Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility

NCT ID: NCT02806336

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-03
• Study Completion Date: 2022-06-30

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 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.

Detailed Description

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.

Conditions

Obesity; Dysmobility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Multi Modal Balance Training (MMBI)

Intervention Type: BEHAVIORAL

Group balance class, obstacle course, strengthening exercises

Weight Loss (WL)

Intervention Type: BEHAVIORAL

Nutritional counseling to achieve 500 kcal standard hypocaloric diet

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).

Group Type: ACTIVE_COMPARATOR

Multi Modal Balance Training (MMBI)

Intervention Type: BEHAVIORAL

Group balance class, obstacle course, strengthening exercises

Interventions

Multi Modal Balance Training (MMBI)

Group balance class, obstacle course, strengthening exercises

Intervention Type: BEHAVIORAL

Weight Loss (WL)

Nutritional counseling to achieve 500 kcal standard hypocaloric diet

Intervention Type: BEHAVIORAL

Other Intervention Names

MMBI; WL

Eligibility Criteria

Inclusion Criteria

• Age >= 60
• Body Mass Index (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
• New York Heart Association 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 a supervised exercise program or Weight Management Program for Veterans (MOVE)
• Poorly controlled diabetes as defined by HbA1C >10% or frequent hypoglycemic episodes
• Currently undergoing chemotherapy and/or radiation therapy for cancer treatment

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie I Katzel, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Locations

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1I01RX001813-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

E1813-R

Identifier Type: -

Identifier Source: org_study_id