Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial
IMPORTANCE: Supervised high-intensity walking exercise that induces ischemic leg symptoms is the first-line therapy for people with lower-extremity peripheral artery disease (PAD), but adherence is poor. OBJECTIVE: To determine whether low-intensity home-based walking exercise at a comfortable pace...
Gespeichert in:
| Veröffentlicht in: | JAMA : the journal of the American Medical Association 2021-04, Vol.325 (13), p.1266-1276 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 1276 |
|---|---|
| container_issue | 13 |
| container_start_page | 1266 |
| container_title | JAMA : the journal of the American Medical Association |
| container_volume | 325 |
| creator | McDermott, Mary M Spring, Bonnie Tian, Lu Treat-Jacobson, Diane Ferrucci, Luigi Lloyd-Jones, Donald Zhao, Lihui Polonsky, Tamar Kibbe, Melina R Bazzano, Lydia Guralnik, Jack M Forman, Daniel E Rego, Al Zhang, Dongxue Domanchuk, Kathryn Leeuwenburgh, Christiaan Sufit, Robert Smith, Brittany Manini, Todd Criqui, Michael H Rejeski, W. Jack |
| description | IMPORTANCE: Supervised high-intensity walking exercise that induces ischemic leg symptoms is the first-line therapy for people with lower-extremity peripheral artery disease (PAD), but adherence is poor. OBJECTIVE: To determine whether low-intensity home-based walking exercise at a comfortable pace significantly improves walking ability in people with PAD vs high-intensity home-based walking exercise that induces ischemic leg symptoms and vs a nonexercise control. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized clinical trial conducted at 4 US centers and including 305 participants. Enrollment occurred between September 25, 2015, and December 11, 2019; final follow-up was October 7, 2020. INTERVENTIONS: Participants with PAD were randomized to low-intensity walking exercise (n = 116), high-intensity walking exercise (n = 124), or nonexercise control (n = 65) for 12 months. Both exercise groups were asked to walk for exercise in an unsupervised setting 5 times per week for up to 50 minutes per session wearing an accelerometer to document exercise intensity and time. The low-intensity group walked at a pace without ischemic leg symptoms. The high-intensity group walked at a pace eliciting moderate to severe ischemic leg symptoms. Accelerometer data were viewable to a coach who telephoned participants weekly for 12 months and helped them adhere to their prescribed exercise. The nonexercise control group received weekly educational telephone calls for 12 months. MAIN OUTCOMES AND MEASURES: The primary outcome was mean change in 6-minute walk distance at 12 months (minimum clinically important difference, 8-20 m). RESULTS: Among 305 randomized patients (mean age, 69.3 [SD, 9.5] years, 146 [47.9%] women, 181 [59.3%] Black patients), 250 (82%) completed 12-month follow-up. The 6-minute walk distance changed from 332.1 m at baseline to 327.5 m at 12-month follow-up in the low-intensity exercise group (within-group mean change, −6.4 m [95% CI, −21.5 to 8.8 m]; P = .34) and from 338.1 m to 371.2 m in the high-intensity exercise group (within-group mean change, 34.5 m [95% CI, 20.1 to 48.9 m]; P |
| doi_str_mv | 10.1001/jama.2021.2536 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8025122</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><ama_id>2778112</ama_id><sourcerecordid>2514708765</sourcerecordid><originalsourceid>FETCH-LOGICAL-a397t-694bef92e9ee8bf4295e5d296394fe1966cacb73af952d993d5deebca6bbc1db3</originalsourceid><addsrcrecordid>eNpdkktvEzEUhS0EoqGwZcECWWLDZoIf87BZIJUQSKRIVCioS8vjuZM4zNjBnhTC_-F_4iFtVfDG0r3fPT5XPgg9p2RKCaFvdrrXU0YYnbKClw_QhBZcZLyQ4iGaECJFVuUiP0NPYtyRdCivHqMzzgWjQooJ-j1vWzAD9i1e-R_Z0g3goh2O-Drihd1s71UWvofsvY7Q4CvdfbNug-c_IRgbAXv3t4Y_2DhoZwBbhy_1YMENEV_ZYYsvIdj9FoLu8EUYIBxHFpLaW7zeAl4t13P8RbvG9_ZXemHWWWdNgtfB6u4petTqLsKzm_scff04X88W2erzp-XsYpVpLqshK2VeQysZSABRtzmTBRQNkyWXeQtUlqXRpq64bmXBGil5UzQAtdFlXRva1PwcvTvp7g91D41J9pNhtQ-21-GovLbq346zW7Xx10oQVlDGksDrG4Hgvx8gDqq30UDXaQf-EBUriGRlRThJ6Kv_0J0_BJfWSxTNKyKqskjU9ESZ4GMM0N6ZoUSNCVBjAtSYADUmIA28vL_CHX775Ql4cQLGudsuqypBKeN_AIDcuCU</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2514708765</pqid></control><display><type>article</type><title>Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial</title><source>MEDLINE</source><source>American Medical Association Journals</source><creator>McDermott, Mary M ; Spring, Bonnie ; Tian, Lu ; Treat-Jacobson, Diane ; Ferrucci, Luigi ; Lloyd-Jones, Donald ; Zhao, Lihui ; Polonsky, Tamar ; Kibbe, Melina R ; Bazzano, Lydia ; Guralnik, Jack M ; Forman, Daniel E ; Rego, Al ; Zhang, Dongxue ; Domanchuk, Kathryn ; Leeuwenburgh, Christiaan ; Sufit, Robert ; Smith, Brittany ; Manini, Todd ; Criqui, Michael H ; Rejeski, W. Jack</creator><creatorcontrib>McDermott, Mary M ; Spring, Bonnie ; Tian, Lu ; Treat-Jacobson, Diane ; Ferrucci, Luigi ; Lloyd-Jones, Donald ; Zhao, Lihui ; Polonsky, Tamar ; Kibbe, Melina R ; Bazzano, Lydia ; Guralnik, Jack M ; Forman, Daniel E ; Rego, Al ; Zhang, Dongxue ; Domanchuk, Kathryn ; Leeuwenburgh, Christiaan ; Sufit, Robert ; Smith, Brittany ; Manini, Todd ; Criqui, Michael H ; Rejeski, W. Jack</creatorcontrib><description>IMPORTANCE: Supervised high-intensity walking exercise that induces ischemic leg symptoms is the first-line therapy for people with lower-extremity peripheral artery disease (PAD), but adherence is poor. OBJECTIVE: To determine whether low-intensity home-based walking exercise at a comfortable pace significantly improves walking ability in people with PAD vs high-intensity home-based walking exercise that induces ischemic leg symptoms and vs a nonexercise control. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized clinical trial conducted at 4 US centers and including 305 participants. Enrollment occurred between September 25, 2015, and December 11, 2019; final follow-up was October 7, 2020. INTERVENTIONS: Participants with PAD were randomized to low-intensity walking exercise (n = 116), high-intensity walking exercise (n = 124), or nonexercise control (n = 65) for 12 months. Both exercise groups were asked to walk for exercise in an unsupervised setting 5 times per week for up to 50 minutes per session wearing an accelerometer to document exercise intensity and time. The low-intensity group walked at a pace without ischemic leg symptoms. The high-intensity group walked at a pace eliciting moderate to severe ischemic leg symptoms. Accelerometer data were viewable to a coach who telephoned participants weekly for 12 months and helped them adhere to their prescribed exercise. The nonexercise control group received weekly educational telephone calls for 12 months. MAIN OUTCOMES AND MEASURES: The primary outcome was mean change in 6-minute walk distance at 12 months (minimum clinically important difference, 8-20 m). RESULTS: Among 305 randomized patients (mean age, 69.3 [SD, 9.5] years, 146 [47.9%] women, 181 [59.3%] Black patients), 250 (82%) completed 12-month follow-up. The 6-minute walk distance changed from 332.1 m at baseline to 327.5 m at 12-month follow-up in the low-intensity exercise group (within-group mean change, −6.4 m [95% CI, −21.5 to 8.8 m]; P = .34) and from 338.1 m to 371.2 m in the high-intensity exercise group (within-group mean change, 34.5 m [95% CI, 20.1 to 48.9 m]; P < .001) and the mean change for the between-group comparison was −40.9 m (97.5% CI, −61.7 to −20.0 m; P < .001). The 6-minute walk distance changed from 328.1 m at baseline to 317.5 m at 12-month follow-up in the nonexercise control group (within-group mean change, −15.1 m [95% CI, −35.8 to 5.7 m]; P = .10), which was not significantly different from the change in the low-intensity exercise group (between-group mean change, 8.7 m [97.5% CI, −17.0 to 34.4 m]; P = .44). Of 184 serious adverse events, the event rate per participant was 0.64 in the low-intensity group, 0.65 in the high-intensity group, and 0.46 in the nonexercise control group. One serious adverse event in each exercise group was related to study participation. CONCLUSIONS AND RELEVANCE: Among patients with PAD, low-intensity home-based exercise was significantly less effective than high-intensity home-based exercise and was not significantly different from the nonexercise control for improving 6-minute walk distance. These results do not support the use of low-intensity home-based walking exercise for improving objectively measured walking performance in patients with PAD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02538900</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.2021.2536</identifier><identifier>PMID: 33821898</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Accelerometers ; Adverse events ; Aged ; Biopsy ; Clinical trials ; Exercise Therapy - methods ; Female ; Humans ; Ischemia ; Ischemia - therapy ; Leg ; Lower Extremity - blood supply ; Lower Extremity - pathology ; Male ; Muscle, Skeletal - pathology ; Original Investigation ; Peripheral Arterial Disease - pathology ; Peripheral Arterial Disease - physiopathology ; Peripheral Arterial Disease - therapy ; Signs and symptoms ; Telephone calls ; Vascular diseases ; Walk Test ; Walking</subject><ispartof>JAMA : the journal of the American Medical Association, 2021-04, Vol.325 (13), p.1266-1276</ispartof><rights>Copyright American Medical Association Apr 6, 2021</rights><rights>Copyright 2021 American Medical Association. All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a397t-694bef92e9ee8bf4295e5d296394fe1966cacb73af952d993d5deebca6bbc1db3</citedby><cites>FETCH-LOGICAL-a397t-694bef92e9ee8bf4295e5d296394fe1966cacb73af952d993d5deebca6bbc1db3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.2021.2536$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2021.2536$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,230,314,776,780,881,3327,27901,27902,76231,76234</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33821898$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>McDermott, Mary M</creatorcontrib><creatorcontrib>Spring, Bonnie</creatorcontrib><creatorcontrib>Tian, Lu</creatorcontrib><creatorcontrib>Treat-Jacobson, Diane</creatorcontrib><creatorcontrib>Ferrucci, Luigi</creatorcontrib><creatorcontrib>Lloyd-Jones, Donald</creatorcontrib><creatorcontrib>Zhao, Lihui</creatorcontrib><creatorcontrib>Polonsky, Tamar</creatorcontrib><creatorcontrib>Kibbe, Melina R</creatorcontrib><creatorcontrib>Bazzano, Lydia</creatorcontrib><creatorcontrib>Guralnik, Jack M</creatorcontrib><creatorcontrib>Forman, Daniel E</creatorcontrib><creatorcontrib>Rego, Al</creatorcontrib><creatorcontrib>Zhang, Dongxue</creatorcontrib><creatorcontrib>Domanchuk, Kathryn</creatorcontrib><creatorcontrib>Leeuwenburgh, Christiaan</creatorcontrib><creatorcontrib>Sufit, Robert</creatorcontrib><creatorcontrib>Smith, Brittany</creatorcontrib><creatorcontrib>Manini, Todd</creatorcontrib><creatorcontrib>Criqui, Michael H</creatorcontrib><creatorcontrib>Rejeski, W. Jack</creatorcontrib><title>Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>IMPORTANCE: Supervised high-intensity walking exercise that induces ischemic leg symptoms is the first-line therapy for people with lower-extremity peripheral artery disease (PAD), but adherence is poor. OBJECTIVE: To determine whether low-intensity home-based walking exercise at a comfortable pace significantly improves walking ability in people with PAD vs high-intensity home-based walking exercise that induces ischemic leg symptoms and vs a nonexercise control. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized clinical trial conducted at 4 US centers and including 305 participants. Enrollment occurred between September 25, 2015, and December 11, 2019; final follow-up was October 7, 2020. INTERVENTIONS: Participants with PAD were randomized to low-intensity walking exercise (n = 116), high-intensity walking exercise (n = 124), or nonexercise control (n = 65) for 12 months. Both exercise groups were asked to walk for exercise in an unsupervised setting 5 times per week for up to 50 minutes per session wearing an accelerometer to document exercise intensity and time. The low-intensity group walked at a pace without ischemic leg symptoms. The high-intensity group walked at a pace eliciting moderate to severe ischemic leg symptoms. Accelerometer data were viewable to a coach who telephoned participants weekly for 12 months and helped them adhere to their prescribed exercise. The nonexercise control group received weekly educational telephone calls for 12 months. MAIN OUTCOMES AND MEASURES: The primary outcome was mean change in 6-minute walk distance at 12 months (minimum clinically important difference, 8-20 m). RESULTS: Among 305 randomized patients (mean age, 69.3 [SD, 9.5] years, 146 [47.9%] women, 181 [59.3%] Black patients), 250 (82%) completed 12-month follow-up. The 6-minute walk distance changed from 332.1 m at baseline to 327.5 m at 12-month follow-up in the low-intensity exercise group (within-group mean change, −6.4 m [95% CI, −21.5 to 8.8 m]; P = .34) and from 338.1 m to 371.2 m in the high-intensity exercise group (within-group mean change, 34.5 m [95% CI, 20.1 to 48.9 m]; P < .001) and the mean change for the between-group comparison was −40.9 m (97.5% CI, −61.7 to −20.0 m; P < .001). The 6-minute walk distance changed from 328.1 m at baseline to 317.5 m at 12-month follow-up in the nonexercise control group (within-group mean change, −15.1 m [95% CI, −35.8 to 5.7 m]; P = .10), which was not significantly different from the change in the low-intensity exercise group (between-group mean change, 8.7 m [97.5% CI, −17.0 to 34.4 m]; P = .44). Of 184 serious adverse events, the event rate per participant was 0.64 in the low-intensity group, 0.65 in the high-intensity group, and 0.46 in the nonexercise control group. One serious adverse event in each exercise group was related to study participation. CONCLUSIONS AND RELEVANCE: Among patients with PAD, low-intensity home-based exercise was significantly less effective than high-intensity home-based exercise and was not significantly different from the nonexercise control for improving 6-minute walk distance. These results do not support the use of low-intensity home-based walking exercise for improving objectively measured walking performance in patients with PAD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02538900</description><subject>Accelerometers</subject><subject>Adverse events</subject><subject>Aged</subject><subject>Biopsy</subject><subject>Clinical trials</subject><subject>Exercise Therapy - methods</subject><subject>Female</subject><subject>Humans</subject><subject>Ischemia</subject><subject>Ischemia - therapy</subject><subject>Leg</subject><subject>Lower Extremity - blood supply</subject><subject>Lower Extremity - pathology</subject><subject>Male</subject><subject>Muscle, Skeletal - pathology</subject><subject>Original Investigation</subject><subject>Peripheral Arterial Disease - pathology</subject><subject>Peripheral Arterial Disease - physiopathology</subject><subject>Peripheral Arterial Disease - therapy</subject><subject>Signs and symptoms</subject><subject>Telephone calls</subject><subject>Vascular diseases</subject><subject>Walk Test</subject><subject>Walking</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkktvEzEUhS0EoqGwZcECWWLDZoIf87BZIJUQSKRIVCioS8vjuZM4zNjBnhTC_-F_4iFtVfDG0r3fPT5XPgg9p2RKCaFvdrrXU0YYnbKClw_QhBZcZLyQ4iGaECJFVuUiP0NPYtyRdCivHqMzzgWjQooJ-j1vWzAD9i1e-R_Z0g3goh2O-Drihd1s71UWvofsvY7Q4CvdfbNug-c_IRgbAXv3t4Y_2DhoZwBbhy_1YMENEV_ZYYsvIdj9FoLu8EUYIBxHFpLaW7zeAl4t13P8RbvG9_ZXemHWWWdNgtfB6u4petTqLsKzm_scff04X88W2erzp-XsYpVpLqshK2VeQysZSABRtzmTBRQNkyWXeQtUlqXRpq64bmXBGil5UzQAtdFlXRva1PwcvTvp7g91D41J9pNhtQ-21-GovLbq346zW7Xx10oQVlDGksDrG4Hgvx8gDqq30UDXaQf-EBUriGRlRThJ6Kv_0J0_BJfWSxTNKyKqskjU9ESZ4GMM0N6ZoUSNCVBjAtSYADUmIA28vL_CHX775Ql4cQLGudsuqypBKeN_AIDcuCU</recordid><startdate>20210406</startdate><enddate>20210406</enddate><creator>McDermott, Mary M</creator><creator>Spring, Bonnie</creator><creator>Tian, Lu</creator><creator>Treat-Jacobson, Diane</creator><creator>Ferrucci, Luigi</creator><creator>Lloyd-Jones, Donald</creator><creator>Zhao, Lihui</creator><creator>Polonsky, Tamar</creator><creator>Kibbe, Melina R</creator><creator>Bazzano, Lydia</creator><creator>Guralnik, Jack M</creator><creator>Forman, Daniel E</creator><creator>Rego, Al</creator><creator>Zhang, Dongxue</creator><creator>Domanchuk, Kathryn</creator><creator>Leeuwenburgh, Christiaan</creator><creator>Sufit, Robert</creator><creator>Smith, Brittany</creator><creator>Manini, Todd</creator><creator>Criqui, Michael H</creator><creator>Rejeski, W. Jack</creator><general>American Medical Association</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20210406</creationdate><title>Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial</title><author>McDermott, Mary M ; Spring, Bonnie ; Tian, Lu ; Treat-Jacobson, Diane ; Ferrucci, Luigi ; Lloyd-Jones, Donald ; Zhao, Lihui ; Polonsky, Tamar ; Kibbe, Melina R ; Bazzano, Lydia ; Guralnik, Jack M ; Forman, Daniel E ; Rego, Al ; Zhang, Dongxue ; Domanchuk, Kathryn ; Leeuwenburgh, Christiaan ; Sufit, Robert ; Smith, Brittany ; Manini, Todd ; Criqui, Michael H ; Rejeski, W. Jack</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a397t-694bef92e9ee8bf4295e5d296394fe1966cacb73af952d993d5deebca6bbc1db3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Accelerometers</topic><topic>Adverse events</topic><topic>Aged</topic><topic>Biopsy</topic><topic>Clinical trials</topic><topic>Exercise Therapy - methods</topic><topic>Female</topic><topic>Humans</topic><topic>Ischemia</topic><topic>Ischemia - therapy</topic><topic>Leg</topic><topic>Lower Extremity - blood supply</topic><topic>Lower Extremity - pathology</topic><topic>Male</topic><topic>Muscle, Skeletal - pathology</topic><topic>Original Investigation</topic><topic>Peripheral Arterial Disease - pathology</topic><topic>Peripheral Arterial Disease - physiopathology</topic><topic>Peripheral Arterial Disease - therapy</topic><topic>Signs and symptoms</topic><topic>Telephone calls</topic><topic>Vascular diseases</topic><topic>Walk Test</topic><topic>Walking</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>McDermott, Mary M</creatorcontrib><creatorcontrib>Spring, Bonnie</creatorcontrib><creatorcontrib>Tian, Lu</creatorcontrib><creatorcontrib>Treat-Jacobson, Diane</creatorcontrib><creatorcontrib>Ferrucci, Luigi</creatorcontrib><creatorcontrib>Lloyd-Jones, Donald</creatorcontrib><creatorcontrib>Zhao, Lihui</creatorcontrib><creatorcontrib>Polonsky, Tamar</creatorcontrib><creatorcontrib>Kibbe, Melina R</creatorcontrib><creatorcontrib>Bazzano, Lydia</creatorcontrib><creatorcontrib>Guralnik, Jack M</creatorcontrib><creatorcontrib>Forman, Daniel E</creatorcontrib><creatorcontrib>Rego, Al</creatorcontrib><creatorcontrib>Zhang, Dongxue</creatorcontrib><creatorcontrib>Domanchuk, Kathryn</creatorcontrib><creatorcontrib>Leeuwenburgh, Christiaan</creatorcontrib><creatorcontrib>Sufit, Robert</creatorcontrib><creatorcontrib>Smith, Brittany</creatorcontrib><creatorcontrib>Manini, Todd</creatorcontrib><creatorcontrib>Criqui, Michael H</creatorcontrib><creatorcontrib>Rejeski, W. Jack</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>McDermott, Mary M</au><au>Spring, Bonnie</au><au>Tian, Lu</au><au>Treat-Jacobson, Diane</au><au>Ferrucci, Luigi</au><au>Lloyd-Jones, Donald</au><au>Zhao, Lihui</au><au>Polonsky, Tamar</au><au>Kibbe, Melina R</au><au>Bazzano, Lydia</au><au>Guralnik, Jack M</au><au>Forman, Daniel E</au><au>Rego, Al</au><au>Zhang, Dongxue</au><au>Domanchuk, Kathryn</au><au>Leeuwenburgh, Christiaan</au><au>Sufit, Robert</au><au>Smith, Brittany</au><au>Manini, Todd</au><au>Criqui, Michael H</au><au>Rejeski, W. Jack</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2021-04-06</date><risdate>2021</risdate><volume>325</volume><issue>13</issue><spage>1266</spage><epage>1276</epage><pages>1266-1276</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><abstract>IMPORTANCE: Supervised high-intensity walking exercise that induces ischemic leg symptoms is the first-line therapy for people with lower-extremity peripheral artery disease (PAD), but adherence is poor. OBJECTIVE: To determine whether low-intensity home-based walking exercise at a comfortable pace significantly improves walking ability in people with PAD vs high-intensity home-based walking exercise that induces ischemic leg symptoms and vs a nonexercise control. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized clinical trial conducted at 4 US centers and including 305 participants. Enrollment occurred between September 25, 2015, and December 11, 2019; final follow-up was October 7, 2020. INTERVENTIONS: Participants with PAD were randomized to low-intensity walking exercise (n = 116), high-intensity walking exercise (n = 124), or nonexercise control (n = 65) for 12 months. Both exercise groups were asked to walk for exercise in an unsupervised setting 5 times per week for up to 50 minutes per session wearing an accelerometer to document exercise intensity and time. The low-intensity group walked at a pace without ischemic leg symptoms. The high-intensity group walked at a pace eliciting moderate to severe ischemic leg symptoms. Accelerometer data were viewable to a coach who telephoned participants weekly for 12 months and helped them adhere to their prescribed exercise. The nonexercise control group received weekly educational telephone calls for 12 months. MAIN OUTCOMES AND MEASURES: The primary outcome was mean change in 6-minute walk distance at 12 months (minimum clinically important difference, 8-20 m). RESULTS: Among 305 randomized patients (mean age, 69.3 [SD, 9.5] years, 146 [47.9%] women, 181 [59.3%] Black patients), 250 (82%) completed 12-month follow-up. The 6-minute walk distance changed from 332.1 m at baseline to 327.5 m at 12-month follow-up in the low-intensity exercise group (within-group mean change, −6.4 m [95% CI, −21.5 to 8.8 m]; P = .34) and from 338.1 m to 371.2 m in the high-intensity exercise group (within-group mean change, 34.5 m [95% CI, 20.1 to 48.9 m]; P < .001) and the mean change for the between-group comparison was −40.9 m (97.5% CI, −61.7 to −20.0 m; P < .001). The 6-minute walk distance changed from 328.1 m at baseline to 317.5 m at 12-month follow-up in the nonexercise control group (within-group mean change, −15.1 m [95% CI, −35.8 to 5.7 m]; P = .10), which was not significantly different from the change in the low-intensity exercise group (between-group mean change, 8.7 m [97.5% CI, −17.0 to 34.4 m]; P = .44). Of 184 serious adverse events, the event rate per participant was 0.64 in the low-intensity group, 0.65 in the high-intensity group, and 0.46 in the nonexercise control group. One serious adverse event in each exercise group was related to study participation. CONCLUSIONS AND RELEVANCE: Among patients with PAD, low-intensity home-based exercise was significantly less effective than high-intensity home-based exercise and was not significantly different from the nonexercise control for improving 6-minute walk distance. These results do not support the use of low-intensity home-based walking exercise for improving objectively measured walking performance in patients with PAD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02538900</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>33821898</pmid><doi>10.1001/jama.2021.2536</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0098-7484 |
| ispartof | JAMA : the journal of the American Medical Association, 2021-04, Vol.325 (13), p.1266-1276 |
| issn | 0098-7484 1538-3598 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8025122 |
| source | MEDLINE; American Medical Association Journals |
| subjects | Accelerometers Adverse events Aged Biopsy Clinical trials Exercise Therapy - methods Female Humans Ischemia Ischemia - therapy Leg Lower Extremity - blood supply Lower Extremity - pathology Male Muscle, Skeletal - pathology Original Investigation Peripheral Arterial Disease - pathology Peripheral Arterial Disease - physiopathology Peripheral Arterial Disease - therapy Signs and symptoms Telephone calls Vascular diseases Walk Test Walking |
| title | Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-10T21%3A49%3A32IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effect%20of%20Low-Intensity%20vs%20High-Intensity%20Home-Based%20Walking%20Exercise%20on%20Walk%20Distance%20in%20Patients%20With%20Peripheral%20Artery%20Disease:%20The%20LITE%20Randomized%20Clinical%20Trial&rft.jtitle=JAMA%20:%20the%20journal%20of%20the%20American%20Medical%20Association&rft.au=McDermott,%20Mary%20M&rft.date=2021-04-06&rft.volume=325&rft.issue=13&rft.spage=1266&rft.epage=1276&rft.pages=1266-1276&rft.issn=0098-7484&rft.eissn=1538-3598&rft_id=info:doi/10.1001/jama.2021.2536&rft_dat=%3Cproquest_pubme%3E2514708765%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2514708765&rft_id=info:pmid/33821898&rft_ama_id=2778112&rfr_iscdi=true |