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OpenTrials
Completed

NCT Number: NCT02806336

Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility

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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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi Modal Balance Training (MMBI)

Behavioral

Group balance class, obstacle course, strengthening exercises

Other names: MMBI

Weight Loss (WL)

Behavioral

Nutritional counseling to achieve 500 kcal standard hypocaloric diet

Other names: WL

Primary outcomes

  1. Change in 6 Minute Walk Distance

    Time frame: 6 months

    Distance walked during the 6 minute walking test

Secondary outcomes

  1. Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement

    Time frame: 6 months

    6 minute walk with submaximal assessment of oxygen uptake as a measure of fitness.

  2. Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan

    Time frame: baseline, 6 months

    The DXA scan provides information about the body composition including total body fat, and lean muscle mass

  3. Change in Gait Biomechanics

    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.

  4. Change in Short Physical Performance Battery

    Time frame: baseline, 3 months

    overall short physical performance battery score. Scale range 0 - 12 with higher scores indicating better possible function.

  5. Change in Four Square Step Test

    Time frame: baseline, 3 months

    Dynamic test of balance involving change in stepping direction.

  6. Change in 8 Foot up and go

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: RISE

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jun 20, 2016
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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