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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| VA Maryland Health Care System | FED |
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Falls and their consequences are among the major problems in the medical care of older individuals. The long-term goal of this research is to establish the efficacy of a scientifically grounded and mechanism-based therapeutic intervention for improving balance function and preventing falls in older people. When human balance is challenged, protective stepping is a vital strategy for preventing a fall during activities of daily life. Many older people at risk for falls have particular difficulties with successfully stepping sideways as a protective response to loss of balance in the lateral direction. We propose that age-related declines in lateral balance function through impaired protective stepping that precipitates falls, result from neuromechanical (NM) limitations in hip abductor-adductor (AB-AD) muscle strength (torque and power). Moreover, we hypothesize that these functional and NM impairments are reversible with combined high intensity induced step training (IST) and muscle strengthening.
Falls and their consequences are among the major problems in the medical care of older individuals. Some 30 percent of community dwelling people aged 65 years and older, and over 50 percent of those living in institutions fall each year. Among older adults, complications of falls are the leading cause of deaths due to injury and are the most common cause of nonfatal injuries and hospitalization for trauma. The total lifetime healthcare cost of fall-related injuries for the elderly have been projected to reach $85 billion by the year 2020. Even in the absence of injury due to falling, the tendency to lose balance among the elderly commonly results in an overall reduction in the level of physical activity, and to a decreased ability to satisfactorily function in social roles.
Despite the contributions of multiple risk factors to age-related falls (e.g., environmental hazards, orthostatic hypotension, disorientation, sedation), it is well recognized that those who fall present greater impairments in neuromechanical (NM) factors than do older non-fallers. Aging changes in balance and gait associated with NM impairments have also been consistently found to be among the most important risk factors for falls. What is presently unresolved, however, is which among the age-associated NM impairments, altered balance and mobility functions are best associated with falls and responsive to interventions (training).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induced Step Training (IST) | Active Comparator | The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping. |
|
| Hip Strength Training (HST) | Active Comparator | The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises. |
|
| Combined Induced Step and Hip Strength Training | Active Comparator | This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST). |
|
| Standard Flexibility and Relaxation (SFR) | Placebo Comparator | The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Training Interventions | Other | Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Hip Abductor Torque | Hip abductor torque at baseline and 3 months | At baseline and post-test at 3 months |
| Step Count | The number of balance recovery steps at balance tolerance threshold at baseline and 3 months | At baseline and post-test at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Falls | Analysis of fall history between falls in the year prior to enrollment and 12 months after training finished. | Individual subject at 12 months post training |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark W Rogers, PT, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PTRS Research Lab | Baltimore | Maryland | 21201 | United States | ||
| VA Maryland Health Care System |
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| ID | Title | Description |
|---|---|---|
| FG000 | Induced Step Training (IST) | The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping. Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
| FG001 | Hip Strength Training (HST) | The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises. Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
| FG002 | Combined Induced Step and Hip Strength Training | This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST). Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
| FG003 | Standard Flexibility and Relaxation (SFR) | The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises. Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Induced Step Training (IST) | The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping. Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Hip Abductor Torque | Hip abductor torque at baseline and 3 months | Posted | Mean | Standard Error | Nm/kg-m | At baseline and post-test at 3 months |
|
18 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 | Induced Step Training (IST) | The IST group will receive waist-pulls in both the left and right lateral directions by a motorized pulling system to produce stepping. Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vicki Gray Principal Investigator | University of Maryland | 4107063778 | vicki.gray@som.umaryland.edu |
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|
| Baltimore |
| Maryland |
| 21201 |
| United States |
| BG001 | Hip Strength Training (HST) | The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises. Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
| BG002 | Combined Induced Step and Hip Strength Training | This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST). Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
| BG003 | Standard Flexibility and Relaxation (SFR) | The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises. Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hip Strength Training (HST) |
The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises. Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
| OG002 | Combined Induced Step and Hip Strength Training | This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST). Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
| OG003 | Standard Flexibility and Relaxation (SFR) | The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises. Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. |
|
|
| Primary | Step Count | The number of balance recovery steps at balance tolerance threshold at baseline and 3 months | Posted | Mean | Standard Error | steps | At baseline and post-test at 3 months |
|
|
|
| Secondary | Falls | Analysis of fall history between falls in the year prior to enrollment and 12 months after training finished. | Not all study participants completed the falls following. The falls follow up was removed late in the trial. | Posted | Mean | 95% Confidence Interval | #falls/person/year | Individual subject at 12 months post training |
|
|
|
| 0 |
| 25 |
| 6 |
| 25 |
| EG001 | Hip Strength Training (HST) | The HST group will have muscle strength training, to include hip abduction (AB) and adduction (AD) resistance exercises. Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. | 0 | 26 | 4 | 26 |
| EG002 | Combined Induced Step and Hip Strength Training | This training group consists of combined induced step training (IST) and hip AB-AD strength training (HST). Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. | 0 | 25 | 5 | 25 |
| EG003 | Standard Flexibility and Relaxation (SFR) | The SFR group will perform a flexibility and relaxation program involving minimal-intensity exercises. Physical Training Interventions: Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises. | 0 | 26 | 1 | 26 |
| R Leg Bruise | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Quad and Hip Abductor Soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| R Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| R Arm Abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Redness/Swelling of Scrotum | Reproductive system and breast disorders | Systematic Assessment |
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| Belching/Burping | Gastrointestinal disorders | Systematic Assessment |
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| Muscle Soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hip Flexor Cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Abdominal Cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| Post-Test Balance Recovery Steps |
|