Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Two group RCT
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Assessor blinded to group, statistical analyses blinded to group

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Behavioral: Multi Modal Balance Training
    Group balance class, obstacle course, strengthening exercises
    Other names:
    • MMBI
  • Behavioral: Weight Loss
    Nutritional counseling to achieve 500 kcal standard hypocaloric diet
    Other names:
    • WL
Active Comparator
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).
  • Behavioral: Multi Modal Balance Training
    Group balance class, obstacle course, strengthening exercises
    Other names:
    • MMBI

More Details

Status
Completed
Sponsor
VA Office of Research and Development

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.