Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility

Phase 2

Completed

• Conditions: Obesity; Dysmobility
• Interventions: Behavioral: Multi Modal Balance Training; Behavioral: Weight Loss

• Registration Number: NCT02806336
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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 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.

Detailed Description

Note: new recruitment on hold due to COVID-19

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.

Study Timeline

• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Study Start: 2016-10-03
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Age >= 60
• BMI >= 30 kg/m2
• Dysmobility as define by 1 or more of the following: Use of or prescribed an assistive walking device, measured gait speed < 1.0 m/s, Four Square Step Test >/= 12 secs OR inability to complete the Four Square Step Test, and/or self-reported difficulty walking 1 km.
• Community dwelling

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Exclusion Criteria

• Unable to walk >0.2 mph on a treadmill for 2 minutes
• Poorly controlled hypertension >180 systolic or >100 diastolic
• Episodes of acute coronary syndrome, coronary revascularization, or major cardiac/vascular procedures within the prior 6 months
• NYHA Class 3 or 4 heart failure
• Symptomatic angina at rest or during exercise
• Syncope within the past 12 months without known cause or resolution
• Chronic lung disease required oxygen dependency
• Severe spinal stenosis limiting ambulation
• Known dementia
• Mini Mental State Exam score <24
• Transtibial or above the knee amputation
• Currently enrolled and active in Gerofit or MOVE
• Poorly controlled diabetes as defined by HbA1C >10% or frequent hypoglycemic episodes
• Currently undergoing chemotherapy and/or radiation therapy for cancer treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi Modal Balance Training & Weight Loss	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 & Weight Loss	Multi Modal Balance Training	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 Only	Multi Modal Balance Training	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).

Primary Outcome Measures

Name	Time	Method
Change in 6 minute walk distance	baseline, 3 months, 6 months, 12 months, 24 months	Distance walked during the 6 minute walking test

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life, LLDFI	baseline, 3 months, 6 months, 12 months, 24 months	LLDFI Questionnaires
Change in four square step test	baseline, 3 months, 6 months, 12 months, 24 months	Dynamic test of balance involving change in stepping direction.
Change in gait biomechanics	baseline, 3 months, 6 months, 12 months, 24 months	Gait biomechanics as assessed by walking mechanics on the GAITmat
Change in short physical performance battery	baseline, 3 months, 6 months, 12 months, 24 months	Component scores of the standing balance battery, usual gait speed, and repeated chair stands (which make up the short physical performance battery test); as well as overall short physical performance battery score
Change in ADL/IADL questionnaire	baseline, 3 months, 6 months, 12 months, 24 months	Self-reported ability to complete activities of daily living and independent activities of daily living.
Change in MoCA	baseline, 3 months, 6 months, 12 months, 24 months	Questionnaire assessing global cognitive function
Change in VO2peak	baseline, 6 months, 12 months, 24 months	VO2peak measured during graded exercise treadmill test to volitional fatigue
Change in 6 minute walk with VO2 measurement	baseline, 3 months, 6 months, 12 months, 24 months	6 minute walk with submaximal assessment of oxygen uptake.
Change in Muscle mass/body composition as assessed by DXA scan	baseline, 6 months, 12 months, 24 months	DXA scan
Change in 8 foot up and go	baseline, 3 months, 6 months, 12 months, 24 months	Time to get up from a chair and walk around a cone 8 feet away and sit back down, representing agility.
Change in Muscle mass/body composition as assessed by CT scan	baseline, 6 months, 12 months, 24 months	CT scan
Change in CHAMPS questionnaire	baseline, 3 months, 6 months, 12 months, 24 months	Self-reported physical activities questionnaire.

Trial Locations

Locations (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD; 🇺🇸 Baltimore, Maryland, United States