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.
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.
authors.affiliation: Department of Cardiology, University Hospital of South Manchester, Wythenshawe, Manchester, United Kingdom.
authors.forename: Martin
authors.initials: M
authors.lastname: Stout
authors.forename: Garry A
authors.initials: GA
authors.lastname: Tew
authors.forename: Helen
authors.initials: H
authors.lastname: Doll
authors.forename: Irena
authors.initials: I
authors.lastname: Zwierska
authors.forename: Nicola
authors.initials: N
authors.lastname: Woodroofe
authors.forename: Kevin S
authors.initials: KS
authors.lastname: Channer
authors.forename: John M
authors.initials: JM
authors.lastname: Saxton
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000728:Androgens / Q000008:administration & dosage*; D015992:Body Mass Index; D002908:Chronic Disease; D015331:Cohort Studies; D003131:Combined Modality Therapy; D003863:Depression; D004311:Double-Blind Method; D004452:Echocardiography; D005080:Exercise Test; D005081:Exercise Therapy; D005240:Feasibility Studies; D006333:Heart Failure / Q000097:blood / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D053580:Muscle Strength; D011788:Quality of Life; D013739:Testosterone / Q000008:administration & dosage* / Q000097:blood; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D000728:Androgens; D013739:Testosterone