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This study is investigating the effects of a home-based resistance exercise program, administered via an interactive telecommunications system, in functionally limited older veterans.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | exercise |
|
| Arm 2 | Other | health education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telecommunications system | Device |
| ||
| attention control |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Extension Strength | The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system | 6 months |
| Knee Flexion Strength | The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Extension Strength (Durability) | The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system | 12 months |
| Knee Flexion Strength (Durability) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David William Sparrow, DSc | VA Boston Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Health Care System | Boston | Massachusetts | 02130 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Automated Exercise Group | Telecommunications system for exercise |
| FG001 | Attention Control Group | attention control (health education) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Telecommunications system for exercise |
| BG001 | Arm 2 | attention control (health education) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knee Extension Strength | The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system | number of subjects completing 6 month evaluations | Posted | Mean | Standard Deviation | kg | 6 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Automated Exercise Group | Telecommunications system for exercise |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stroke | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inury/discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Sparrow | VA Boston Healthcare System | 857-364-6407 | david.sparrow@va.gov |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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health education |
|
The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system
| 12 months |
| 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. | 12 months |
| 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. | 12 months |
| 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. | 12 months |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Knee Extension Strength (Durability) | The peak force measured during the bilateral knee extension exercise against the highest level of a hydraulic resistance system | Posted | Mean | Standard Deviation | kg | 12 months |
|
|
|
| Primary | Knee Flexion Strength | The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system | Number of subjects completing 6 month evaluations | Posted | Mean | Standard Deviation | kg | 6 months |
|
|
|
| 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. | The number of subjects completing 6 month evaluations | Posted | Mean | Standard Deviation | s | 6 months |
|
|
|
| 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. | The number of subjects completing 6 month evaluations | Posted | Mean | Standard Deviation | s | 6 months |
|
|
|
| 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. | The number of subjects completing 6 month evaluations | Posted | Mean | Standard Deviation | m | 6 months |
|
|
|
| Secondary | Knee Flexion Strength (Durability) | The peak force measured during the bilateral knee flexion exercise against the highest level of a hydraulic resistance system | Posted | Mean | Standard Deviation | kg | 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | s | 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | s | 12 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | m | 12 months |
|
|
|
| 6 |
| 52 |
| 8 |
| 52 |
| EG001 | Attention Control Group | attention control (health education) | 7 | 51 | 7 | 51 |
| atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| bypass surgery | Cardiac disorders | Non-systematic Assessment |
|
| kidney surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| knee replacement surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| total hip replacement surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| wrist injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| hand and rib injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| torn cartilage in knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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