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Testosterone therapy as an adjunct to exercise rehabilitation: effects on exercise capacity, inflammatory markers and quality of life in hypogonadal males with chronic heart failure
ISRCTN ISRCTN99667121
DOI 10.1186/ISRCTN99667121
ClinicalTrials.gov identifier
EudraCT number
Public title Testosterone therapy as an adjunct to exercise rehabilitation: effects on exercise capacity, inflammatory markers and quality of life in hypogonadal males with chronic heart failure
Scientific title
Acronym TEST-EX
Serial number at source RG2511/06/07
Study hypothesis Exercise rehabilitation and adjunctive testosterone therapy will evoke greater improvements in exercise capacity, circulating inflammatory markers, cardiac and skeletal muscle function, indices of psychological health status and quality of life than exercise alone in hypogonadal males with chronic heart failure.
Lay summary Not provided at time of registration
Ethics approval Ethics approval granted by the South Sheffield Research Ethics Committee (REC reference number: 06/Q2308/73), date of approval: June 2nd, 2006.
Study design Randomised double-blind placebo-controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Hypogonadal males with chronic heart failure
Participants - inclusion criteria 1. Ambulant males
2. Over 18 years
3. Stable chronic heart failure
4. Blood testosterone level of less than 12 nmol/l
5. Symptoms of hypogonadism
Participants - exclusion criteria 1. Unstable agina
2. Recent acute myocardial infarction
3. Decompensated heart failure
4. Haemodyamically significant valvular heart disease
5. Uncontrolled hypertension
6. Renal insufficiency
7. Urologic disorders
8. Orthopedic/neurologic illness limiting the ability to exercise
Anticipated start date 01/09/2006
Anticipated end date 31/08/2007
Status of trial Completed
Patient information material
Target number of participants 36
Interventions Exercise alone versus exercise and adjunctive testosterone therapy.
Primary outcome measure(s) Exercise capacity at the 12 week time point in relation to baseline.
Secondary outcome measure(s) 1. Inflammatory markers
2. Tests of cardiac and skeletal muscle function
3. Indices of psychological health status
4. Quality of life
Sources of funding Heart Research (UK) (reference number: RG2511/06/07)
Trial website
Publications 1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17137495
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23194490
Contact name Dr  John  Saxton
  Address Centre for Sport and Exercise Science
Sheffield Hallam University
Collegiate Crescent Campus
  City/town Sheffield
  Zip/Postcode S10 2BP
  Country United Kingdom
Sponsor Heart Research (UK)
  Address Suite 12D
Joseph's Well
  City/town Leeds
  Zip/Postcode LS3 1AB
  Country United Kingdom
  Sponsor website: http://www.heartresearch.org.uk
Date applied 21/08/2006
Last edited 18/02/2013
Date ISRCTN assigned 13/09/2006
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