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	https://doi.org/10.1186/ISRCTN99667121
Protocol serial number	RG2511/06/07
Sponsor	Heart Research (UK)
Funder	Heart Research (UK) (reference number: RG2511/06/07)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr John Saxton
Scientific

Centre for Sport and Exercise Science
Sheffield Hallam University
Collegiate Crescent Campus
Sheffield
S10 2BP
United Kingdom

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	TEST-EX
Study objectives	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.
Ethics approval(s)	Ethics approval granted by the South Sheffield Research Ethics Committee (REC reference number: 06/Q2308/73), date of approval: June 2nd, 2006.
Health condition(s) or problem(s) studied	Hypogonadal males with chronic heart failure
Intervention	Exercise alone versus exercise and adjunctive testosterone therapy.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Testosterone
Primary outcome measure(s)	Exercise capacity at the 12 week time point in relation to baseline.
Key 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
Completion date	31/08/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	36
Key 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
Key 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
Date of first enrolment	01/09/2006
Date of final enrolment	31/08/2007

Centre for Sport and Exercise Science

Sheffield
S10 2BP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2012		Yes	No
Protocol article	protocol	30/11/2006		Yes	No