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Trial registered on ANZCTR


Registration number
ACTRN12615000191594
Ethics application status
Approved
Date submitted
16/02/2015
Date registered
26/02/2015
Date last updated
3/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oxandrolone and Progressive Resistance Training in Older Women with Early Frailty
Scientific title
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.
Secondary ID [1] 286182 0
Pfizer Protocol Number: A9001008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 294210 0
Condition category
Condition code
Musculoskeletal 294527 294527 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294589 294589 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291193 0
Treatment: Drugs
Intervention code [2] 291194 0
Treatment: Other
Intervention code [3] 291240 0
Lifestyle
Comparator / control treatment
Progressive Resistance Training with Placebo

The placebo tablet will be identical in in appearance, packaging, taste and texture. Participants will be given identical instructions (2 x 2.5mg tablets, twice per day), and adherence will be monitored by self-report and the returning of empty packaging.

The progressive resistance training program will be identical in both groups.

Participants will undergo both interventions simultaneously.
Control group
Placebo

Outcomes
Primary outcome [1] 294305 0
Muscle Fiber Cross-sectional Area assessed using muscle biopsies obtained from the Vastus Lateralis
Timepoint [1] 294305 0
12 weeks
Secondary outcome [1] 312998 0
Body Composition assessed using DEXA scan
Timepoint [1] 312998 0
12 weeks
Secondary outcome [2] 312999 0
Muscle Strength (1RM) on the Leg Press, Knee Extension, Knee Flexion, Chest Press and Triceps Pushdown.
Timepoint [2] 312999 0
12 Weeks
Secondary outcome [3] 313078 0
Functional Performance assessed using
* Habitual Gait Speed
* Maximal Gait Speed
* 6 minute walk test
* Chair rise
* Stair climb
* Static Balance assessed using half-tandem, tandem and one-leg
* Dynamic balance assessed using forward and backward tandem walk over 6 meters (20 feet).
Timepoint [3] 313078 0
12 Weeks
Secondary outcome [4] 313100 0
Muscle Power on the Leg Press and Chest Press
Timepoint [4] 313100 0
12 weeks

Eligibility
Key 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.
Minimum age
65 Years
Maximum age
90 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Mini-Mental State Examination score < 24


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization was performed by Pfizer central office, and randomization sequence was kept offsite. Randomization occurred at the completion of the entire baseline assessment via email to pharmacy staff who prepared study medications for each participant, distributed by research staff identified as “A” or “B” only.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size estimates were based on the adaptive response of muscle as determined by muscle fiber cross sectional area. The change in subjects receiving resistance training with oxandrolone is difficult to hypothesize based on the absence of comparable data in the literature. However, Fiatarone et al showed that the combination of nutrition and progressive resistance training (PRT) increased type II fiber diameter by 21.6% compared to resistance training alone (1). Thus, with an alpha of 0.05 and a power of 0.8, a sample size of 32 (16 in each group) was required to detect a significant change in type II fiber area in participants receiving oxandrolone compared to those receiving placebo.

Sequential linear mixed-effects models with repeated measures will be used to determine the effects of group assignment over time for all dependent variables, using an intention-to-treat analytic strategy without regard to adherence or dropout.

1. Fiatarone Singh, M.A., et al., Insulin-like growth factor I in skeletal muscle after weight-lifting exercise in frail elders. Vol. 277. 1999. E135-E143.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6662 0
United States of America
State/province [1] 6662 0
Massachusetts

Funding & Sponsors
Funding source category [1] 290752 0
Commercial sector/Industry
Name [1] 290752 0
Pfizer Inc.
Address [1] 290752 0
Eastern Point Road, Groton, Connecticut 06340
Country [1] 290752 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Pfizer Inc.
Address
Easters Point Road, Groton, Connecticut 06340
Country
United States of America
Secondary sponsor category [1] 289438 0
None
Name [1] 289438 0
Address [1] 289438 0
Country [1] 289438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292384 0
Hebrew Rehabilitation Center for Aged
Ethics committee address [1] 292384 0
1200 Centre Street, Boston, MA 02131
Ethics committee country [1] 292384 0
United States of America
Date submitted for ethics approval [1] 292384 0
Approval date [1] 292384 0
07/08/2000
Ethics approval number [1] 292384 0
00-011

Summary
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.
Trial website
Trial related presentations / publications
Mavros, Y., O’Neill, E., Connerty, M., Bean, JF., Broe, K., Kiel, DP., MacLean, D., Taylor, A., Fielding, RA., Fiatarone Singh, MA. Oxandrolone augmentation of resistance training in older women: A randomized trial. Medicine and Science in Sport and Exercise. 2015, 47(11):2257-2267. DOI: 10.1249/MSS.0000000000000690
Public notes

Contacts
Principal investigator
Name 54946 0
Prof Maria Fiatarone Singh
Address 54946 0
University of Sydney,
Faculty of Health Sciences
75 East Street
Lidcombe NSW 2141
Country 54946 0
Australia
Phone 54946 0
+61293519755
Fax 54946 0
Email 54946 0
maria.fataronesingh@sydney.edu.au
Contact person for public queries
Name 54947 0
Prof Maria Fiatarone Singh
Address 54947 0
University of Sydney,
Faculty of Health Sciences
75 East Street
Lidcombe NSW 2141
Country 54947 0
Australia
Phone 54947 0
+61293519755
Fax 54947 0
Email 54947 0
maria.fataronesingh@sydney.edu.au
Contact person for scientific queries
Name 54948 0
Prof Maria Fiatarone Singh
Address 54948 0
University of Sydney,
Faculty of Health Sciences
75 East Street
Lidcombe NSW 2141
Country 54948 0
Australia
Phone 54948 0
+61293519755
Fax 54948 0
Email 54948 0
maria.fataronesingh@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary