Oxandrolone and Progressive Resistance Training in Older Women with Early Frailty

Completed

• Conditions: Frailty; Musculoskeletal - Other muscular and skeletal disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12615000191594
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 29

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Muscle Fiber Cross-sectional Area assessed using muscle biopsies obtained from the Vastus Lateralis[12 weeks]

Secondary Outcome Measures

Name	Time	Method
Body Composition assessed using DEXA scan[12 weeks];Muscle Strength (1RM) on the Leg Press, Knee Extension, Knee Flexion, Chest Press and Triceps Pushdown. [12 Weeks];Functional Performance assessed using <br>* Habitual Gait Speed<br>* Maximal Gait Speed<br>* 6 minute walk test<br>* Chair rise<br>* Stair climb<br>* Static Balance assessed using half-tandem, tandem and one-leg<br>* Dynamic balance assessed using forward and backward tandem walk over 6 meters (20 feet).[12 Weeks];Muscle Power on the Leg Press and Chest Press[12 weeks]