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
Secondary identifying numbers RG2511/06/07
Submission date
21/08/2006
Registration date
13/09/2006
Last edited
18/02/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr John Saxton
Scientific

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

Study information

Study designRandomised double-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymTEST-EX
Study objectivesExercise 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) studiedHypogonadal males with chronic heart failure
InterventionExercise alone versus exercise and adjunctive testosterone therapy.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Testosterone
Primary outcome measureExercise capacity at the 12 week time point in relation to baseline.
Secondary outcome measures1. Inflammatory markers
2. Tests of cardiac and skeletal muscle function
3. Indices of psychological health status
4. Quality of life
Overall study start date01/09/2006
Completion date31/08/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexMale
Target number of participants36
Key inclusion criteria1. 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 criteria1. 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 enrolment01/09/2006
Date of final enrolment31/08/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Centre for Sport and Exercise Science
Sheffield
S10 2BP
United Kingdom

Sponsor information

Heart Research (UK)
Charity

Suite 12D
Joseph's Well
Leeds
LS3 1AB
United Kingdom

http://www.heartresearch.org.uk
ROR logo https://ror.org/04j68sw28

Funders

Funder type

Not defined

Heart Research (UK) (reference number: RG2511/06/07)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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