Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000048482
Ethics application status
Approved
Date submitted
8/11/2006
Date registered
16/01/2007
Date last updated
16/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multimodal Exercise for Functional Independence in Older Women: A randomized, sham-exercise controlled clinical Trial
Scientific title
Multimodal Exercise for Functional Independence in Older Women: A randomized, sham-exercise controlled clinical Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional impairment and disability in older women 1541 0
Condition category
Condition code
Public Health 1640 1640 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Power, strength, and aerobic exercise training
Setting: Supervised by a research assistant in a gym set up in the residence of the participants (subsidized apartments for the elderly)
Modality: Machine-based multi-modal training using Keiser pneumatic resistance machines, Nu-step seated stepper machines and StairMaster stairclimber machine.
Frequency: 3 days per week
Intensity: Power training at 80% 1 repetition maximum, progressed each session as guided by daily use of Borg perceived exertion scale (15-17/20 or "hard to lift") and monthly repeat 1 repetition maximum testing. Strength training at 80% of 1 repetition maximum, progressed as for power training each session throughout the year. Aerobic training at 60% Heart rate reserve, calculated from peak aerobic capacity testing with indirect calorimetry, and progressed each session as guided by heart rate monitors during all exercise bouts and perceived exertion (12-14/20 on Borg perceived exertion scale).
Volume: Each session lasted approximately 1 hour. 1 set of 8 repetitions of strength training, 1 set of 8 repetitions of power training, 20 minutes of aerobic exercise.
Speed of contraction: As fast as possible for concentric phase for power training, 3 seconds for eccentric phase, 1 second rest between reps, 1 min rest between sets minimum. For strength training, same except that concentric phase lasted 3 seconds.
Machines used: Chest press, seated row, leg press, hip abduction, knee extension.
Length of intervention: 1 year.
Intervention code [1] 1436 0
Lifestyle
Comparator / control treatment
Control group: Seated stretching and mild calesthenics for 1 hour , 2 days per week in small group setting supervised by research assistant. Heart rate monitored to keep it within 10 beats of resting heart rate. No use of equipment, no progression over the course of the year.
Control group
Placebo

Outcomes
Primary outcome [1] 2261 0
Functional performance (Short physical performance battery; Physical performance Test)
Timepoint [1] 2261 0
Measured at baseline, 6 and 12 months
Primary outcome [2] 2262 0
Self-reported Disability (NHANES epidemiological follow-up survey questionnaire, Instrumental Activities of Daily Living Score)
Timepoint [2] 2262 0
Measured at baseline, 6 and 12 months
Secondary outcome [1] 3939 0
Muscle strength
Timepoint [1] 3939 0
Measured at baseline, 6 and 12 months
Secondary outcome [2] 3940 0
Muscle power
Timepoint [2] 3940 0
Measured at baseline, 6 and 12 months
Secondary outcome [3] 3941 0
Aerobic capacity
Timepoint [3] 3941 0
Measured at baseline, 6 and 12 months
Secondary outcome [4] 3942 0
Sub-maximal aerobic response (double-product, oxygen consumption, anaerobic threshold, Oxygen uptake efficiency slope)
Timepoint [4] 3942 0
Measured at baseline, 6 and 12 months
Secondary outcome [5] 3943 0
Muscle fiber type and cross-sectional area
Timepoint [5] 3943 0
Measured at baseline, 6 and 12 months
Secondary outcome [6] 3944 0
Mid-thigh and mid arm muscle, fat, and bone areas
Timepoint [6] 3944 0
Measured at baseline, 6 and 12 months
Secondary outcome [7] 3945 0
Total body water
Timepoint [7] 3945 0
Measured at baseline, 6 and 12 months
Secondary outcome [8] 3946 0
Depressive symptoms
Timepoint [8] 3946 0
Measured at baseline, 6 and 12 months
Secondary outcome [9] 3947 0
Health-related quality of Life
Timepoint [9] 3947 0
Measured at baseline, 6 and 12 months
Secondary outcome [10] 3948 0
Physical activity level
Timepoint [10] 3948 0
Measured at baseline, 6 and 12 months
Secondary outcome [11] 3949 0
Six minute walk distance
Timepoint [11] 3949 0
Measured at baseline, 6 and 12 months
Secondary outcome [12] 3950 0
Habitual and maximal gait speed
Timepoint [12] 3950 0
Measured at baseline, 6 and 12 months
Secondary outcome [13] 3951 0
Static and Dynamic balance
Timepoint [13] 3951 0
Measured at baseline, 6 and 12 months
Secondary outcome [14] 3952 0
Self-efficacy
Timepoint [14] 3952 0
Measured at baseline, 6 and 12 months

Eligibility
Key inclusion criteria
Living in senior housing apartment complex where study was carried outOne or more falls in the past 12 months ORDifficulty on at least one activity other than vigorous activities from the physical function sub-scale of the Medical OUtcomes Survey Short-Form 36.
Minimum age
70 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speakingMaleUnwillingness to be randomized or undergo protocols or exercise for 1 yearAny unstable chronic disease precluding exercise testing or training such as unstable angina, recent MI, terminal illness, malginant arrthymias, dementia, current suicidality or psychosis, known aneurysm, amputation, non-ambulatory status.Residence in non-community seting such as nursing home or other institution.

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)
Treatment assignments were generated by a statistician not otherwise involved in the trial and were handed to the volunteers in opaque sealed envelopes at the conclusion of all baseline testing
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Placebo control group was a sham exercise condition (seated stretching/calesthenics of low intensity) Subjects were blinded to the investigators' hypotheses as to which was the preferred intervention. Muscle strength and power and physical performance testing was single-blinded. Therapists (Exercise trainers) were not blinded. Data collection by research staff was not blinded except for blood tests, stress tests and computerized tomography scanning. Data analyst was blinded for body composition, muscle biopsy, nutritional biochemistries, aerobic capacity testing and gait analysis. Questionnaires were interveiwer-administered. Subjects were blinded as to which was the hypothesized effective intervention, both were presented as potentially beneficial for the study outcomes.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/1995
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1785 0
Government body
Name [1] 1785 0
National Institute on Aging
Country [1] 1785 0
United States of America
Funding source category [2] 1786 0
Government body
Name [2] 1786 0
United States Department of Agriculture
Country [2] 1786 0
United States of America
Primary sponsor type
Other
Name
National Institute on Aging (NIA)
Address
Country
United States of America
Secondary sponsor category [1] 1592 0
Government body
Name [1] 1592 0
United States Department of Agriculture (USDA)
Address [1] 1592 0
Country [1] 1592 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3344 0
USDA Human Nutrition Center on Aging at Tufts University
Ethics committee address [1] 3344 0
Boston, Mass
Ethics committee country [1] 3344 0
United States of America
Date submitted for ethics approval [1] 3344 0
Approval date [1] 3344 0
Ethics approval number [1] 3344 0

Summary
Brief summary
Disability in older adults is multi-factorial, and in part related to age-related changes in exercise capacity, including muscle strength, power, and endurance. To address these multiple areas, more than one kind of exercise may be needed to optimize function. Therefore, we are testing the efficacy of a combined program of strength, power and cardiovascular fitness training on functional independence, health status, psycholgocial health and physical performance over one year.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27370 0
Address 27370 0
Country 27370 0
Phone 27370 0
Fax 27370 0
Email 27370 0
Contact person for public queries
Name 10625 0
Maria A. Fiatarone Singh
Address 10625 0
School of Exercise and Sport Science
East Street
Lidcombe, NSW2141
Country 10625 0
Australia
Phone 10625 0
+61 2 93519755
Fax 10625 0
+61 2 93519204
Email 10625 0
[email protected]
Contact person for scientific queries
Name 1553 0
Maria A. Fiatarone Singh
Address 1553 0
School of Exercise and Sport Science
East Street
Lidcombe, NSW 2141
Country 1553 0
Australia
Phone 1553 0
+61 2 93519755
Fax 1553 0
+61 2 93519204
Email 1553 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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