Not Yet RecruitingPhase 3ACTRN12619001408178

A novel development of liver-targeted androgen therapy for sarcopenia and synergistic benefit of resistance training in elderly


Sponsor

UNSW Sydney

Enrollment

212 participants

Start Date

Jan 1, 2020

Study Type

Interventional

Conditions

Summary

A randomized controlled trial will establish the extent of an increase in muscle mass and function during the novel liver-targeted testosterone therapy in older men and women with sarcopenia. We will combine this with progressive resistance training component in half of the patients to investigate independent and exercise-stimulated synergistic effects of resistance training and liver-targeted testosterone in improving muscle mass and function in sarcopenia.


Eligibility

Sex: Both males and femalesMin Age: 75 YearssMax Age: 90 Yearss

Inclusion Criteria1

  • Community dwellers with sarcopenia but independent mobility. Sarcopenia will be defined by established clinical criteria: handgrip strength of 37 kg or less for men and 21 kg or less for women; or 12 seconds or more to rise 5 times from a chair with arms folded on the chest. Participants should be able to walk at least 10 m and climb at least one stair step without assistance.

Exclusion Criteria1

  • Overt cardiac failure, active non-skin malignancy, diabetes mellitus, uncontrolled hypertension (systolic BP > 160 mmHg), end-stage kidney or liver failure, recent fractures, neurological impairments, joint replacements, planned surgery within next 6 months, and BMI>35 kg/m2.

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Interventions

Oral crystalline unconjugated testosterone 40 mg/day for 6 months. Testosterone will be administered in 1 capsule (13.3 mg/capsule) 3 times a day. Adherence will be monotored by returned unused capsul

Oral crystalline unconjugated testosterone 40 mg/day for 6 months. Testosterone will be administered in 1 capsule (13.3 mg/capsule) 3 times a day. Adherence will be monotored by returned unused capsules. Participants will be randomized to either receive progressive resistance training or no training for 6 months. Participants in the resistance training group will perform a partially supervised resistance training program for 6 months. Individually supervised sessions (~40 min) will be performed twice per week at the exercise laboratory at UNSW. For each session, participants will perform a warm-up of 5 minutes’ of low-intensity walking on the treadmill and lower-body flexibility exercises. This will be followed by ~ 30 minutes of upper- and lower-body resistance training, such as leg press, leg extension, calf raise, chest press, and seated row. In addition, resistance bands and adjustable dumbbells will be used to strengthen the muscle groups not targeted specifically by the resistance machines. The final 5 min of each session will be a cool down period, involving stretching of the major muscle groups. In addition to supervised sessions, participants will be asked to perform one home-based resistance training session per week, with 8-10 exercises targeting the major muscle groups using adjustable dumbbells and body weight loading. Online instructional videos and a printed training manual will also be provided for each exercise. Compliance to training will be recorded in a training log by the participants. Thus, there will be four groups (active drug+training, active drug no training, placebo drug + training, placebo drug no training).


Locations(1)

Prince of Wales Hospital - Randwick

NSW, Australia

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