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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02806336
Collaborator
(none)
37
Enrollment
1
Location
2
Arms
68.9
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Multi Modal Balance Training
  • Behavioral: Weight Loss
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two group RCTTwo group RCT
Masking:
Single (Outcomes Assessor)
Masking Description:
Assessor blinded to group, statistical analyses blinded to group
Primary Purpose:
Treatment
Official Title:
Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility
Actual Study Start Date :
Oct 3, 2016
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

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
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Change in VO2peak [baseline, 6 months, 12 months, 24 months]

      VO2peak measured during graded exercise treadmill test to volitional fatigue

    2. 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.

    3. Change in Muscle mass/body composition as assessed by DXA scan [baseline, 6 months, 12 months, 24 months]

      DXA scan

    4. Change in Quality of Life, LLDFI [baseline, 3 months, 6 months, 12 months, 24 months]

      LLDFI Questionnaires

    5. Change in gait biomechanics [baseline, 3 months, 6 months, 12 months, 24 months]

      Gait biomechanics as assessed by walking mechanics on the GAITmat

    6. 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

    7. Change in four square step test [baseline, 3 months, 6 months, 12 months, 24 months]

      Dynamic test of balance involving change in stepping direction.

    8. 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.

    9. Change in Muscle mass/body composition as assessed by CT scan [baseline, 6 months, 12 months, 24 months]

      CT scan

    10. 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.

    11. Change in CHAMPS questionnaire [baseline, 3 months, 6 months, 12 months, 24 months]

      Self-reported physical activities questionnaire.

    12. Change in MoCA [baseline, 3 months, 6 months, 12 months, 24 months]

      Questionnaire assessing global cognitive function

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Baltimore Maryland United States 21201

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Leslie Ira Katzel, MD PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT02806336
    Other Study ID Numbers:
    • E1813-R
    • 1I01RX001813-01A1
    First Posted:
    Jun 20, 2016
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by VA Office of Research and Development
    exercise training
    assistive device
    weight loss
    function
    mobility
    Additional relevant MeSH terms:
    Weight Loss

    Study Results

    No Results Posted as of Jul 15, 2022