Testosterone therapy during exercise rehabilitation in male patients with chronic heart failure who have low testosterone status: A double-blind randomized controlled feasibility study
Background This study assessed the feasibility of a 12-week program of exercise, with and without intramuscular testosterone supplementation, in male patients with chronic heart failure (CHF) and low testosterone status and collected preliminary data for key health outcomes. Methods Male patients wi...
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| Veröffentlicht in: | The American heart journal 2012-12, Vol.164 (6), p.893-901 |
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| creator | Stout, Martin, MSc Tew, Garry A., PhD Doll, Helen, PhD Zwierska, Irena, PhD Woodroofe, Nicola, PhD Channer, Kevin S., MD Saxton, John M., PhD |
| description | Background This study assessed the feasibility of a 12-week program of exercise, with and without intramuscular testosterone supplementation, in male patients with chronic heart failure (CHF) and low testosterone status and collected preliminary data for key health outcomes. Methods Male patients with CHF (n = 41, age 67.2 years, range 51-84 years) with mean ± SD testosterone levels of 10.7 ± 2.6 nmol/L (309 ± 76 ng/dL) were randomly allocated to exercise with testosterone or placebo groups. Feasibility was assessed in terms of recruitment, intervention compliance, and attrition. Outcomes included an incremental shuttle walk test, peak oxygen uptake, muscular strength, echocardiographic measures, N-terminal pro–brain natriuretic peptide, inflammatory markers, depression (Beck Depression Inventory), and health-related quality of life (Minnesota Living with Heart Failure Questionnaire and Medical Outcomes Study Short-Form). Results Attrition was 30% but with 100% compliance to exercise and injections in patients who completed the study. Similar improvements in shuttle walk test (18% vs 19%), body mass (−1.3 kg vs −1.0 kg), and hand grip strength (2.1 kg vs 2.5 kg) from baseline were observed in both groups. The exercise with testosterone group showed improvements from baseline in peak oxygen uptake ( P < .01), Beck Depression Inventory ( P < .05), leg strength ( P < .05), and several Medical Outcomes Study Short-Form quality of life domains ( P < .05), which were generally not apparent in the exercise with placebo group. Echocardiographic measures, N-terminal pro–brain natriuretic peptide, and inflammatory markers were mostly unchanged. Conclusions This study shows for the first time that testosterone supplementation during a program of exercise rehabilitation is feasible and can positively impact on a range of key health outcomes in elderly male patients with CHF who have a low testosterone status. |
| doi_str_mv | 10.1016/j.ahj.2012.09.016 |
| format | Article |
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Methods Male patients with CHF (n = 41, age 67.2 years, range 51-84 years) with mean ± SD testosterone levels of 10.7 ± 2.6 nmol/L (309 ± 76 ng/dL) were randomly allocated to exercise with testosterone or placebo groups. Feasibility was assessed in terms of recruitment, intervention compliance, and attrition. Outcomes included an incremental shuttle walk test, peak oxygen uptake, muscular strength, echocardiographic measures, N-terminal pro–brain natriuretic peptide, inflammatory markers, depression (Beck Depression Inventory), and health-related quality of life (Minnesota Living with Heart Failure Questionnaire and Medical Outcomes Study Short-Form). Results Attrition was 30% but with 100% compliance to exercise and injections in patients who completed the study. Similar improvements in shuttle walk test (18% vs 19%), body mass (−1.3 kg vs −1.0 kg), and hand grip strength (2.1 kg vs 2.5 kg) from baseline were observed in both groups. The exercise with testosterone group showed improvements from baseline in peak oxygen uptake ( P < .01), Beck Depression Inventory ( P < .05), leg strength ( P < .05), and several Medical Outcomes Study Short-Form quality of life domains ( P < .05), which were generally not apparent in the exercise with placebo group. Echocardiographic measures, N-terminal pro–brain natriuretic peptide, and inflammatory markers were mostly unchanged. Conclusions This study shows for the first time that testosterone supplementation during a program of exercise rehabilitation is feasible and can positively impact on a range of key health outcomes in elderly male patients with CHF who have a low testosterone status.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2012.09.016</identifier><identifier>PMID: 23194490</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>New York, NY: Mosby, Inc</publisher><subject>Aged ; Aged, 80 and over ; Androgens - administration & dosage ; Angina pectoris ; Biological and medical sciences ; Body Mass Index ; Cardiology. Vascular system ; Cardiovascular ; Chronic Disease ; Cohort Studies ; Combined Modality Therapy ; Depression ; Double-Blind Method ; Echocardiography ; Exercise ; Exercise Test ; Exercise Therapy ; Feasibility Studies ; Heart ; Heart attacks ; Heart Failure - blood ; Heart Failure - therapy ; Heart failure, cardiogenic pulmonary edema, cardiac enlargement ; Humans ; Male ; Medical sciences ; Men ; Middle Aged ; Miscellaneous ; Muscle Strength ; Older people ; Quality of Life ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Testosterone - administration & dosage ; Testosterone - blood ; Treatment Outcome ; United Kingdom</subject><ispartof>The American heart journal, 2012-12, Vol.164 (6), p.893-901</ispartof><rights>Mosby, Inc.</rights><rights>2012 Mosby, Inc.</rights><rights>2014 INIST-CNRS</rights><rights>Copyright © 2012 Mosby, Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Dec 2012</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c499t-1e0f7860b150fcc7f1b59d6acbeb96e3d543f994e0993357a18e9ce2567265a13</citedby><cites>FETCH-LOGICAL-c499t-1e0f7860b150fcc7f1b59d6acbeb96e3d543f994e0993357a18e9ce2567265a13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S000287031200659X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26711720$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23194490$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Stout, Martin, MSc</creatorcontrib><creatorcontrib>Tew, Garry A., PhD</creatorcontrib><creatorcontrib>Doll, Helen, PhD</creatorcontrib><creatorcontrib>Zwierska, Irena, PhD</creatorcontrib><creatorcontrib>Woodroofe, Nicola, PhD</creatorcontrib><creatorcontrib>Channer, Kevin S., MD</creatorcontrib><creatorcontrib>Saxton, John M., PhD</creatorcontrib><title>Testosterone therapy during exercise rehabilitation in male patients with chronic heart failure who have low testosterone status: A double-blind randomized controlled feasibility study</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Background This study assessed the feasibility of a 12-week program of exercise, with and without intramuscular testosterone supplementation, in male patients with chronic heart failure (CHF) and low testosterone status and collected preliminary data for key health outcomes. Methods Male patients with CHF (n = 41, age 67.2 years, range 51-84 years) with mean ± SD testosterone levels of 10.7 ± 2.6 nmol/L (309 ± 76 ng/dL) were randomly allocated to exercise with testosterone or placebo groups. Feasibility was assessed in terms of recruitment, intervention compliance, and attrition. Outcomes included an incremental shuttle walk test, peak oxygen uptake, muscular strength, echocardiographic measures, N-terminal pro–brain natriuretic peptide, inflammatory markers, depression (Beck Depression Inventory), and health-related quality of life (Minnesota Living with Heart Failure Questionnaire and Medical Outcomes Study Short-Form). Results Attrition was 30% but with 100% compliance to exercise and injections in patients who completed the study. Similar improvements in shuttle walk test (18% vs 19%), body mass (−1.3 kg vs −1.0 kg), and hand grip strength (2.1 kg vs 2.5 kg) from baseline were observed in both groups. The exercise with testosterone group showed improvements from baseline in peak oxygen uptake ( P < .01), Beck Depression Inventory ( P < .05), leg strength ( P < .05), and several Medical Outcomes Study Short-Form quality of life domains ( P < .05), which were generally not apparent in the exercise with placebo group. Echocardiographic measures, N-terminal pro–brain natriuretic peptide, and inflammatory markers were mostly unchanged. Conclusions This study shows for the first time that testosterone supplementation during a program of exercise rehabilitation is feasible and can positively impact on a range of key health outcomes in elderly male patients with CHF who have a low testosterone status.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Androgens - administration & dosage</subject><subject>Angina pectoris</subject><subject>Biological and medical sciences</subject><subject>Body Mass Index</subject><subject>Cardiology. Vascular system</subject><subject>Cardiovascular</subject><subject>Chronic Disease</subject><subject>Cohort Studies</subject><subject>Combined Modality Therapy</subject><subject>Depression</subject><subject>Double-Blind Method</subject><subject>Echocardiography</subject><subject>Exercise</subject><subject>Exercise Test</subject><subject>Exercise Therapy</subject><subject>Feasibility Studies</subject><subject>Heart</subject><subject>Heart attacks</subject><subject>Heart Failure - blood</subject><subject>Heart Failure - therapy</subject><subject>Heart failure, cardiogenic pulmonary edema, cardiac enlargement</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Men</subject><subject>Middle Aged</subject><subject>Miscellaneous</subject><subject>Muscle Strength</subject><subject>Older people</subject><subject>Quality of Life</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Testosterone - administration & dosage</subject><subject>Testosterone - blood</subject><subject>Treatment Outcome</subject><subject>United Kingdom</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqNks-KFDEQxhtR3HH1AbxIQAQvPSbp7nRHQVgW_8GCB1fwFtJJtZ0x0xmT9I7jk_l41jijK3sQT0mF31dVqfqK4iGjS0aZeLZa6nG15JTxJZVLfLlVLBiVbSnaur5dLCilvOxaWp0U91JaYSh4J-4WJ7xisq4lXRQ_LiHlkDLEMAHJI0S92RE7Rzd9JvANonEJSIRR9867rLMLE3ETWWsPZIMhTDmRrcsjMSPmcIaMoGMmg3Z-jkC2YyCjvgLiw5bkv4slzDan5-SM2DD3Hsreu8mSqCcb1u47WGLClGPwHq8D6OR-tbBD4Wx394s7g_YJHhzP0-Lj61eX52_Li_dv3p2fXZSmljKXDOjQdoL2rKGDMe3A-kZaoU0PvRRQ2aauBilroFJWVdNq1oE0wBvRctFoVp0WTw95NzF8nbF_tXbJgPd6gjAnxQTngrKm_g-Uc8Yq1okK0cc30FWY44QfUdhoLaqukx1S7ECZGFKKMKhNdGsdd4pRtXeAWil0gNo7QFGp8AU1j46Z534N9o_i98oReHIEdDLaDzhv3PE1J1rGWr7nXhw4wOleOYgqGdy2AesimKxscP9s4-UNtcHtOiz4BXaQrn-rEmrUh71V905lHE3ayE_VTwIe5t4</recordid><startdate>20121201</startdate><enddate>20121201</enddate><creator>Stout, Martin, MSc</creator><creator>Tew, Garry A., PhD</creator><creator>Doll, Helen, PhD</creator><creator>Zwierska, Irena, PhD</creator><creator>Woodroofe, Nicola, PhD</creator><creator>Channer, Kevin S., MD</creator><creator>Saxton, John M., PhD</creator><general>Mosby, Inc</general><general>Mosby</general><general>Elsevier Limited</general><scope>IQODW</scope><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>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20121201</creationdate><title>Testosterone therapy during exercise rehabilitation in male patients with chronic heart failure who have low testosterone status: A double-blind randomized controlled feasibility study</title><author>Stout, Martin, MSc ; Tew, Garry A., PhD ; Doll, Helen, PhD ; Zwierska, Irena, PhD ; Woodroofe, Nicola, PhD ; Channer, Kevin S., MD ; Saxton, John M., PhD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c499t-1e0f7860b150fcc7f1b59d6acbeb96e3d543f994e0993357a18e9ce2567265a13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Androgens - administration & dosage</topic><topic>Angina pectoris</topic><topic>Biological and medical sciences</topic><topic>Body Mass Index</topic><topic>Cardiology. Vascular system</topic><topic>Cardiovascular</topic><topic>Chronic Disease</topic><topic>Cohort Studies</topic><topic>Combined Modality Therapy</topic><topic>Depression</topic><topic>Double-Blind Method</topic><topic>Echocardiography</topic><topic>Exercise</topic><topic>Exercise Test</topic><topic>Exercise Therapy</topic><topic>Feasibility Studies</topic><topic>Heart</topic><topic>Heart attacks</topic><topic>Heart Failure - blood</topic><topic>Heart Failure - therapy</topic><topic>Heart failure, cardiogenic pulmonary edema, cardiac enlargement</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Men</topic><topic>Middle Aged</topic><topic>Miscellaneous</topic><topic>Muscle Strength</topic><topic>Older people</topic><topic>Quality of Life</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Testosterone - administration & dosage</topic><topic>Testosterone - blood</topic><topic>Treatment Outcome</topic><topic>United Kingdom</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Stout, Martin, MSc</creatorcontrib><creatorcontrib>Tew, Garry A., PhD</creatorcontrib><creatorcontrib>Doll, Helen, PhD</creatorcontrib><creatorcontrib>Zwierska, Irena, PhD</creatorcontrib><creatorcontrib>Woodroofe, Nicola, PhD</creatorcontrib><creatorcontrib>Channer, Kevin S., MD</creatorcontrib><creatorcontrib>Saxton, John M., PhD</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>ProQuest Nursing and Allied Health Journals</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>ProQuest Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>ProQuest Healthcare Administration Database</collection><collection>Medical Database</collection><collection>ProQuest Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Stout, Martin, MSc</au><au>Tew, Garry A., PhD</au><au>Doll, Helen, PhD</au><au>Zwierska, Irena, PhD</au><au>Woodroofe, Nicola, PhD</au><au>Channer, Kevin S., MD</au><au>Saxton, John M., PhD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Testosterone therapy during exercise rehabilitation in male patients with chronic heart failure who have low testosterone status: A double-blind randomized controlled feasibility study</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2012-12-01</date><risdate>2012</risdate><volume>164</volume><issue>6</issue><spage>893</spage><epage>901</epage><pages>893-901</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><abstract>Background This study assessed the feasibility of a 12-week program of exercise, with and without intramuscular testosterone supplementation, in male patients with chronic heart failure (CHF) and low testosterone status and collected preliminary data for key health outcomes. Methods Male patients with CHF (n = 41, age 67.2 years, range 51-84 years) with mean ± SD testosterone levels of 10.7 ± 2.6 nmol/L (309 ± 76 ng/dL) were randomly allocated to exercise with testosterone or placebo groups. Feasibility was assessed in terms of recruitment, intervention compliance, and attrition. Outcomes included an incremental shuttle walk test, peak oxygen uptake, muscular strength, echocardiographic measures, N-terminal pro–brain natriuretic peptide, inflammatory markers, depression (Beck Depression Inventory), and health-related quality of life (Minnesota Living with Heart Failure Questionnaire and Medical Outcomes Study Short-Form). Results Attrition was 30% but with 100% compliance to exercise and injections in patients who completed the study. Similar improvements in shuttle walk test (18% vs 19%), body mass (−1.3 kg vs −1.0 kg), and hand grip strength (2.1 kg vs 2.5 kg) from baseline were observed in both groups. The exercise with testosterone group showed improvements from baseline in peak oxygen uptake ( P < .01), Beck Depression Inventory ( P < .05), leg strength ( P < .05), and several Medical Outcomes Study Short-Form quality of life domains ( P < .05), which were generally not apparent in the exercise with placebo group. Echocardiographic measures, N-terminal pro–brain natriuretic peptide, and inflammatory markers were mostly unchanged. Conclusions This study shows for the first time that testosterone supplementation during a program of exercise rehabilitation is feasible and can positively impact on a range of key health outcomes in elderly male patients with CHF who have a low testosterone status.</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>23194490</pmid><doi>10.1016/j.ahj.2012.09.016</doi><tpages>9</tpages></addata></record> |
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| subjects | Aged Aged, 80 and over Androgens - administration & dosage Angina pectoris Biological and medical sciences Body Mass Index Cardiology. Vascular system Cardiovascular Chronic Disease Cohort Studies Combined Modality Therapy Depression Double-Blind Method Echocardiography Exercise Exercise Test Exercise Therapy Feasibility Studies Heart Heart attacks Heart Failure - blood Heart Failure - therapy Heart failure, cardiogenic pulmonary edema, cardiac enlargement Humans Male Medical sciences Men Middle Aged Miscellaneous Muscle Strength Older people Quality of Life Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Testosterone - administration & dosage Testosterone - blood Treatment Outcome United Kingdom |
| title | Testosterone therapy during exercise rehabilitation in male patients with chronic heart failure who have low testosterone status: A double-blind randomized controlled feasibility study |
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