Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201, United States
NCT Number: NCT02806336
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.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21201, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group balance class, obstacle course, strengthening exercises
Other names: MMBI
Nutritional counseling to achieve 500 kcal standard hypocaloric diet
Other names: WL
Time frame: 6 months
Distance walked during the 6 minute walking test
Time frame: 6 months
6 minute walk with submaximal assessment of oxygen uptake as a measure of fitness.
Time frame: baseline, 6 months
The DXA scan provides information about the body composition including total body fat, and lean muscle mass
Time frame: 6 months
Gait biomechanics as assessed by walking mechanics on the gait rite mat. Scale range 0 - 24 with higher scores indicating better outcome.
Time frame: baseline, 3 months
overall short physical performance battery score. Scale range 0 - 12 with higher scores indicating better possible function.
Time frame: baseline, 3 months
Dynamic test of balance involving change in stepping direction.
Time frame: baseline, 3 months
Time to get up from a chair and walk around a cone 8 feet away and sit back down, representing agility.
VA Office of Research and Development
Fed
Acronym: RISE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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