ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 364 for:    Recruiting, Not yet recruiting, Available Studies | "weight loss"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02806336
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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
Obesity Dysmobility Behavioral: Multi Modal Balance Training Behavioral: Weight Loss Phase 2 Phase 3

Detailed Description:
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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two 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 : October 3, 2016
Estimated Primary Completion Date : October 3, 2020
Estimated Study Completion Date : October 3, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: MMBI
Behavioral: Weight Loss
Nutritional counseling to achieve 500 kcal standard hypocaloric diet
Other Name: 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 Name: MMBI



Primary Outcome Measures :
  1. Change in 6 minute walk distance [ Time Frame: baseline, 3 months, 6 months, 12 months, 24 months ]
    Distance walked during the 6 minute walking test


Secondary Outcome Measures :
  1. Change in VO2peak [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline, 6 months, 12 months, 24 months ]
    DXA scan

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

  5. Change in gait biomechanics [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline, 6 months, 12 months, 24 months ]
    CT scan

  10. Change in ADL/IADL questionnaire [ Time Frame: 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 [ Time Frame: baseline, 3 months, 6 months, 12 months, 24 months ]
    Self-reported physical activities questionnaire.

  12. Change in MoCA [ Time Frame: baseline, 3 months, 6 months, 12 months, 24 months ]
    Questionnaire assessing global cognitive function



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 60
  • BMI >= 30 kg/m2
  • Use of an assistive device (cane, walker, etc)
  • Mobility limitation as evidenced by observed gait speed <1.0 m/s and/or self-reported difficulty walking 1km
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806336


Contacts
Contact: Leslie I Katzel, MD PhD (410) 605-7248 Leslie.Katzel@va.gov
Contact: Lydia A Paden, MS (410) 605-7000 ext 5444 lydia.paden@va.gov

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21201
Contact: Leslie I Katzel, MD PhD    (410) 605-7248    Leslie.Katzel@va.gov   
Principal Investigator: Leslie Ira Katzel, MD PhD         
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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02806336     History of Changes
Other Study ID Numbers: E1813-R
1I01RX001813-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
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
Body Weight Changes
Body Weight
Signs and Symptoms