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Oxandrolone and Progressive Resistance Training in Older Women with Early Frailty

The Effect of Oxandrolone in Combination with Progressive Resistance Training on Improving Physical Function, Muscle Strength and Power, and Body Composition in Older Women with Early Frailty: A Randomized, Double-Blind, Placebo Controlled Trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000191594
Enrollment
29
Registered
2015-02-26
Start date
2001-02-11
Completion date
2002-01-03
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this investigation is to study the effects of 12 weeks of progressive resistance training (PRT) in combination with 20 mg/day oxandrolone or placebo in older women with early frailty. We hypothesize that PRT plus oxandrolone would show significantly greater increases in lean tissue and reduction in adipose tissue compared to PRT plus placebo. Furthermore, we hypothesize that PRT plus oxandrolone would result in increases in physical function, peak muscle strength [one-repetition maximum (1RM)] as well as muscle peak power compared to participants receiving PRT plus placebo.

Interventions

Progressive Resistance Training combined with Oxandrolone. Participants will be instructed to take 2 x 2.5mg oxandrolone tablets, orally, twice per day (10mg), for the duration of the study (12 weeks). Adherence will be monitored by self-report and the returning of empty packaging by the participants. The progressive resistance training will be performed on Keiser pneumatic resistance equipment 3 days per week for 12 weeks. Training will be fully supervised, one-on-one, by a Nurse and Exe

Progressive Resistance Training combined with Oxandrolone. Participants will be instructed to take 2 x 2.5mg oxandrolone tablets, orally, twice per day (10mg), for the duration of the study (12 weeks). Adherence will be monitored by self-report and the returning of empty packaging by the participants. The progressive resistance training will be performed on Keiser pneumatic resistance equipment 3 days per week for 12 weeks. Training will be fully supervised, one-on-one, by a Nurse and Exercise Physiologist or certified Recreational Therapist. Participants will exercise at a minimum of 80% of their previously determined one-repetition maximum (1RM). Sessions will last approximately 45 minutes. Participants will perform 3 sets of 8 repetitions on the leg press, knee extension, knee flexion, triceps pushdown, plantar flexion and chest press. 1RM testing will be carried out every two weeks to ensure participants are progressed appropriately. Borg rating scales will be used to further titrate the intensity of training by maintaining the resistance between ratings of 15 and 17 at each session. Resistance will be adjusted accordingly if participants develop any musculoskeletal complaints that could be exacerbated with PRT. Participants will undergo both interventions simultaneously.

Sponsors

Pfizer Inc.
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Evidence of a frail or pre-frail condition by demonstration of one of the following: *gait speed between 0.5m/s-0.9m/s *chair rise time >12 seconds *one or more limitation of Nagy’s instrumental activities of daily living *self-reported limitation of the physical component section of the Short Form 36 Health Survey (SF-36), categories B through J inclusive *a loss of 10lb (5kg) or more in the 5 years preceding screening, and a BMI < 24 *one fall within the previous six months, or 2 or more falls within the previous 2 years.

Exclusion criteria

Mini-Mental State Examination score < 24

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026