Functional Limitation
Conditions
Keywords
Activities of daily living, Aging, Exercise, Weight lifting
Brief summary
This study is investigating the effects of a home-based resistance exercise program, administered via an interactive telecommunications system, in functionally limited older veterans.
Detailed description
Inactivity and a sedentary lifestyle have been shown to accelerate and exaggerate the age-related decline in muscle strength. In this context, a rapid decline in strength among older adults has been linked to physical frailty, falls, functional decline, impaired mobility, and nursing home placement. Substantial evidence now suggests that habitual physical activity is associated with the maintenance of muscle strength and physical function well into the 8th and 9th decades of life. We propose to investigate the effects of a home-based resistance exercise program, administered via an interactive telecommunications system without the participation of health professionals, in functionally limited older veterans. Subjects will be randomized to either the automated exercise group or an attention placebo control group. The exercise group will undergo resistance training at home three times a week for 6 months, guided by the telecommunications system, followed by a 6-month maintenance phase of less frequent interaction with the system. Outcome measurements will include muscle strength and physical performance related to daily activities at 3, 6, and 12 months to determine the efficacy of the intervention and the time course and durability of the effect. The control group will also interact with the telecommunications system once a week for the whole year, but no exercise will be prescribed. If this home-based, automated, interactive exercise program is effective, it will provide a low-cost easily disseminated approach to improving the strength and functional status of older veterans
Interventions
DEVICEattention control
health education
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 65 years * Ability to use a telephone without assistance
Exclusion criteria
* Angina pectoris * Myocardial infarction * Ventricular dysrhythmia currently receiving therapy * Systolic blood pressure 165 mm Hg or diastolic blood pressure 100 mm Hg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute Walk | 6 months | Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes. |
| Knee Extension Strength | 6 months | The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system |
| Knee Flexion Strength | 6 months | The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system |
| Single Leg Stance With Eyes Open | 6 months | Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance. |
| Tandem Stance | 6 months | Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Extension Strength (Durability) | 12 months | The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system |
| Knee Flexion Strength (Durability) | 12 months | The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system |
| Single Leg Stance With Eyes Open (Durability) | 12 months | Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance. |
| Tandem Stance (Durability) | 12 months | Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line. |
| Six-minute Walk (Durability) | 12 months | Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Telecommunications system for exercise | 52 |
| Arm 2 attention control (health education) | 51 |
| Total | 103 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age, Continuous | 70.3 years STANDARD_DEVIATION 7.5 | 71.7 years STANDARD_DEVIATION 7.2 | 71 years STANDARD_DEVIATION 7.4 |
| Region of Enrollment United States | 52 participants | 51 participants | 103 participants |
| Sex: Female, Male Female | 17 Participants | 15 Participants | 32 Participants |
| Sex: Female, Male Male | 35 Participants | 36 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 52 | 7 / 51 |
| serious Total, serious adverse events | 6 / 52 | 7 / 51 |
Outcome results
Primary
Knee Extension Strength
The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system
Time frame: 6 months
Population: number of subjects completing 6 month evaluations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Exercise Group | Knee Extension Strength | 20.4 kg | Standard Deviation 0.59 |
| Attention Control Group | Knee Extension Strength | 19.5 kg | Standard Deviation 0.65 |
Primary
Knee Flexion Strength
The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system
Time frame: 6 months
Population: Number of subjects completing 6 month evaluations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Exercise Group | Knee Flexion Strength | 34.3 kg | Standard Deviation 0.76 |
| Attention Control Group | Knee Flexion Strength | 32.2 kg | Standard Deviation 0.77 |
Primary
Single Leg Stance With Eyes Open
Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.
Time frame: 6 months
Population: The number of subjects completing 6 month evaluations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Exercise Group | Single Leg Stance With Eyes Open | 20.9 s | Standard Deviation 1.3 |
| Attention Control Group | Single Leg Stance With Eyes Open | 17.4 s | Standard Deviation 1.3 |
Primary
Six-minute Walk
Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.
Time frame: 6 months
Population: The number of subjects completing 6 month evaluations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Exercise Group | Six-minute Walk | 450.6 m | Standard Deviation 5.09 |
| Attention Control Group | Six-minute Walk | 449.8 m | Standard Deviation 5.22 |
Primary
Tandem Stance
Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.
Time frame: 6 months
Population: The number of subjects completing 6 month evaluations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Exercise Group | Tandem Stance | 54.8 s | Standard Deviation 1.9 |
| Attention Control Group | Tandem Stance | 50.5 s | Standard Deviation 2.35 |
Secondary
Knee Extension Strength (Durability)
The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Exercise Group | Knee Extension Strength (Durability) | 20.3 kg | Standard Deviation 0.71 |
| Attention Control Group | Knee Extension Strength (Durability) | 19.4 kg | Standard Deviation 0.66 |
Secondary
Knee Flexion Strength (Durability)
The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Exercise Group | Knee Flexion Strength (Durability) | 34.5 kg | Standard Deviation 0.81 |
| Attention Control Group | Knee Flexion Strength (Durability) | 32.5 kg | Standard Deviation 0.82 |
Secondary
Single Leg Stance With Eyes Open (Durability)
Length of time standing on one leg without moving the support foot, touching the floor or support leg with suspended foot, or requiring assistance.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Exercise Group | Single Leg Stance With Eyes Open (Durability) | 20.1 s | Standard Deviation 1.35 |
| Attention Control Group | Single Leg Stance With Eyes Open (Durability) | 16.6 s | Standard Deviation 1.39 |
Secondary
Six-minute Walk (Durability)
Total distance walked during 6 minutes. Subjects were instructed to walk up and down a 100-foot level hallway as far as they could in 6 minutes.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Exercise Group | Six-minute Walk (Durability) | 446.8 m | Standard Deviation 4.77 |
| Attention Control Group | Six-minute Walk (Durability) | 446.1 m | Standard Deviation 4.91 |
Secondary
Tandem Stance (Durability)
Length of time standing with the heel of one foot touching the toe of the other foot keeping the feet in a straight line.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Automated Exercise Group | Tandem Stance (Durability) | 55.8 s | Standard Deviation 2.18 |
| Attention Control Group | Tandem Stance (Durability) | 51.6 s | Standard Deviation 2.38 |