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| ID | Type | Description | Link |
|---|---|---|---|
| 1I01RX001813-01A1 | U.S. NIH Grant/Contract | View source |
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Obesity is a major risk factor for mobility problems in older adults and many older adults use a walking aid to help with their mobility. The use of a walking aid changes normal walking patterns and makes walking harder, leading people to have more functional problems. The purpose of this study is to test the effects of 12 months of a multi-modal balance intervention (MMBI) with supervised weight loss compared to MMBI only on fitness, functional performance, balance, and economy of gait. Participants will be one of 120 participants in the VA Maryland Health Care System (VAMHCS). Participation in this study is voluntary. The research will be conducted at the VAMHCS. The entire study will take approximately 4 years to complete. Subjects' participation in the study will last 24 months.
Note: Study has been completed, enrollment and study interventions were severely impacted by coronavirus disease 2019 (COVID)
Older obese adults suffer disproportionately from walking mobility limitations. Sedentary, obese older adults are at an increased risk for having or developing difficulties with mobility. These individuals are often excluded from studies due to their advanced mobility limitations. A number of studies have compared the effects of weight loss alone, exercise alone, or weight loss in combination with exercise on functional performance in older adults, but none of the studies have specifically targeted subjects who use walking assistive devices. The purpose of this study is to test the effects of a 12 month multi-modal exercise rehabilitation intervention with a nutrition program versus a nutrition program only on fitness, functional performance, mobility, and muscle mass. The results of this study will lead to new and more effective interventions that could reduce disability, fall risk, injury-related hospitalization and death in older Veterans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi Modal Balance Training & Weight Loss | Experimental | Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). Weekly nutrition sessions for individual dietary recommendations designed to produce about a 10% weight loss over the first six months of the study. |
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| Multi Modal Balance Training Only | Active Comparator | Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi Modal Balance Training (MMBI) | Behavioral | Group balance class, obstacle course, strengthening exercises |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 Minute Walk Distance | Distance walked during the 6 minute walking test | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement | 6 minute walk with submaximal assessment of oxygen uptake as a measure of fitness. | 6 months |
| Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie I Katzel, MD PhD | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
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Subjects were excluded from the study before assignment to groups due to the corona virus 19 (COVID-19) pandemic and associated research activity shut down.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multi Modal Balance Training & Weight Loss | Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). Weekly nutrition sessions for individual dietary recommendations designed to produce about a 10% weight loss over the first six months of the study. Multi Modal Balance Training: Group balance class, obstacle course, strengthening exercises Weight Loss: Nutritional counseling to achieve 500 kcal standard hypocaloric diet |
| FG001 | Multi Modal Balance Training Only | Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). Multi Modal Balance Training: Group balance class, obstacle course, strengthening exercises |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Multi Modal Balance Training & Weight Loss | Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). Weekly nutrition sessions for individual dietary recommendations designed to produce about a 10% weight loss over the first six months of the study. Multi Modal Balance Training: Group balance class, obstacle course, strengthening exercises Weight Loss: Nutritional counseling to achieve 500 kcal standard hypocaloric diet |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change in 6 Minute Walk Distance | Distance walked during the 6 minute walking test | There may have been certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures or there may have been unforeseen problems with data collection. | Posted | Mean | Standard Deviation | feet | 6 months |
|
Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
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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 | Multi Modal Balance Training & Weight Loss | Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). Weekly nutrition sessions for individual dietary recommendations designed to produce about a 10% weight loss over the first six months of the study. Multi Modal Balance Training: Group balance class, obstacle course, strengthening exercises Weight Loss: Nutritional counseling to achieve 500 kcal standard hypocaloric diet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Conduct of the study was severely impacted by Coronavirus disease (COVID-19) as this study involved center-based exercise. All of the study participants stopped exercising and we were unable to obtain post-intervention outcome data for the longer time points that were proposed in the grant and even the short term outcome data was severely limited and underpowered. Due to their functional limitations the interventions were more labor intensive than had been anticipated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leslie Katzel | Baltimore VA Geriatric Research Education and Clinical Center | 4106057248 | leslie.katzel@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2021 | Mar 20, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2021 | Oct 23, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Two group randomized control trial (RCT)
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Assessor blinded to group, statistical analyses blinded to group
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| Weight Loss (WL) | Behavioral | Nutritional counseling to achieve 500 kcal standard hypocaloric diet |
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The DXA scan provides information about the body composition including total body fat, and lean muscle mass
| baseline, 6 months |
| Change in Gait Biomechanics | Gait biomechanics as assessed by walking mechanics on the gait rite mat. Scale range 0 - 24 with higher scores indicating better outcome. | 6 months |
| Change in Short Physical Performance Battery | overall short physical performance battery score. Scale range 0 - 12 with higher scores indicating better possible function. | baseline, 3 months |
| Change in Four Square Step Test | Dynamic test of balance involving change in stepping direction. | baseline, 3 months |
| Change in 8 Foot up and go | Time to get up from a chair and walk around a cone 8 feet away and sit back down, representing agility. | baseline, 3 months |
| COVID-19 research shut down |
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| Lack of Efficacy |
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| BG001 | Multi Modal Balance Training Only | Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). Multi Modal Balance Training: Group balance class, obstacle course, strengthening exercises |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index (BMI) (kg/m2) | Mean | Standard Deviation | kg/m2 |
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| OG001 | Multi Modal Balance Training Only | Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). Multi Modal Balance Training: Group balance class, obstacle course, strengthening exercises |
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| Secondary | Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement | 6 minute walk with submaximal assessment of oxygen uptake as a measure of fitness. | There were certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures. | Posted | Mean | Standard Deviation | ml/kg/min | 6 months |
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| Secondary | Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan | The DXA scan provides information about the body composition including total body fat, and lean muscle mass | There may have been certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures or there may have been unforeseen problems with data collection. | Posted | Mean | Standard Deviation | grams | baseline, 6 months |
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| Secondary | Change in Gait Biomechanics | Gait biomechanics as assessed by walking mechanics on the gait rite mat. Scale range 0 - 24 with higher scores indicating better outcome. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | Change in Short Physical Performance Battery | overall short physical performance battery score. Scale range 0 - 12 with higher scores indicating better possible function. | There may have been certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures or there may have been unforeseen problems with data collection. | Posted | Mean | Standard Deviation | units on a scale | baseline, 3 months |
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| Secondary | Change in Four Square Step Test | Dynamic test of balance involving change in stepping direction. | There may have been certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures or there may have been unforeseen problems with data collection. | Posted | Mean | Standard Deviation | seconds | baseline, 3 months |
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| Secondary | Change in 8 Foot up and go | Time to get up from a chair and walk around a cone 8 feet away and sit back down, representing agility. | There may have been certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures or there may have been unforeseen problems with data collection. | Posted | Mean | Standard Deviation | seconds | baseline, 3 months |
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| 0 |
| 9 |
| 0 |
| 9 |
| 6 |
| 9 |
| EG001 | Multi Modal Balance Training Only | Supervised exercise 3 times per week for about 1 hour. The classes will consist of a group balance class (about 30 minutes), a supervised obstacle course (about 10 minutes), and lower body and core body strength exercises (about 20 minutes). Multi Modal Balance Training: Group balance class, obstacle course, strengthening exercises | 0 | 11 | 0 | 11 | 5 | 11 |
| Carpal Tunnel Surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Car accident | General disorders | Non-systematic Assessment |
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| Right knee swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | Non-systematic Assessment |
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| Back/hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hypotension | Cardiac disorders | Non-systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Allergic reaction | Immune system disorders | Non-systematic Assessment |
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| Hypoglycemia | Hepatobiliary disorders | Non-systematic Assessment |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| 6 months |
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| 3 months |
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| 3 months |
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| Superiority |
| 3 months |
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