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

Primary Purpose

Obesity, Dysmobility

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Multi Modal Balance Training
Weight Loss
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring exercise training, assistive device, weight loss, function, mobility

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multi Modal Balance Training & Weight Loss

Multi Modal Balance Training Only

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change in 6 minute walk distance
Distance walked during the 6 minute walking test

Secondary Outcome Measures

Change in VO2peak
VO2peak measured during graded exercise treadmill test to volitional fatigue
Change in 6 minute walk with VO2 measurement
6 minute walk with submaximal assessment of oxygen uptake.
Change in Muscle mass/body composition as assessed by DXA scan
DXA scan
Change in Quality of Life, LLDFI
LLDFI Questionnaires
Change in gait biomechanics
Gait biomechanics as assessed by walking mechanics on the GAITmat
Change in short physical performance battery
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
Change in four square step test
Dynamic test of balance involving change in stepping direction.
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.
Change in Muscle mass/body composition as assessed by CT scan
CT scan
Change in ADL/IADL questionnaire
Self-reported ability to complete activities of daily living and independent activities of daily living.
Change in CHAMPS questionnaire
Self-reported physical activities questionnaire.
Change in MoCA
Questionnaire assessing global cognitive function

Full Information

First Posted
June 2, 2016
Last Updated
July 12, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02806336
Brief Title
Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility
Acronym
RISE
Official Title
Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Dysmobility
Keywords
exercise training, assistive device, weight loss, function, mobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Two group RCT
Masking
Outcomes Assessor
Masking Description
Assessor blinded to group, statistical analyses blinded to group
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi Modal Balance Training & Weight Loss
Arm Type
Experimental
Arm Description
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.
Arm Title
Multi Modal Balance Training Only
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Multi Modal Balance Training
Other Intervention Name(s)
MMBI
Intervention Description
Group balance class, obstacle course, strengthening exercises
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss
Other Intervention Name(s)
WL
Intervention Description
Nutritional counseling to achieve 500 kcal standard hypocaloric diet
Primary Outcome Measure Information:
Title
Change in 6 minute walk distance
Description
Distance walked during the 6 minute walking test
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Secondary Outcome Measure Information:
Title
Change in VO2peak
Description
VO2peak measured during graded exercise treadmill test to volitional fatigue
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Change in 6 minute walk with VO2 measurement
Description
6 minute walk with submaximal assessment of oxygen uptake.
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
Change in Muscle mass/body composition as assessed by DXA scan
Description
DXA scan
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Change in Quality of Life, LLDFI
Description
LLDFI Questionnaires
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
Change in gait biomechanics
Description
Gait biomechanics as assessed by walking mechanics on the GAITmat
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
Change in short physical performance battery
Description
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
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
Change in four square step test
Description
Dynamic test of balance involving change in stepping direction.
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
Change in 8 foot up and go
Description
Time to get up from a chair and walk around a cone 8 feet away and sit back down, representing agility.
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
Change in Muscle mass/body composition as assessed by CT scan
Description
CT scan
Time Frame
baseline, 6 months, 12 months, 24 months
Title
Change in ADL/IADL questionnaire
Description
Self-reported ability to complete activities of daily living and independent activities of daily living.
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
Change in CHAMPS questionnaire
Description
Self-reported physical activities questionnaire.
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months
Title
Change in MoCA
Description
Questionnaire assessing global cognitive function
Time Frame
baseline, 3 months, 6 months, 12 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Ira Katzel, MD PhD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility

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