Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility (RISE)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Dysmobility
• Intervention / Treatment: Behavioral: Multi Modal Balance Training (MMBI); Behavioral: Weight Loss (WL)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 (MMBI); Group balance class, obstacle course, strengthening exercises; Other Names: MMBI; Behavioral: Weight Loss (WL); 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 (MMBI); Group balance class, obstacle course, strengthening exercises; Other Names: MMBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6 Minute Walk Distance	Distance walked during the 6 minute walking test	6 months

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Leslie I Katzel, MD PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2016
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimated): June 20, 2016

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: function; mobility; weight loss; exercise training; assistive device
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: E1813-R; 1I01RX001813-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No