N/A
N=20
Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility
Obesity · Dysmobility
Bottom Line
View on ClinicalTrials.gov: NCT02806336 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in 6 Minute Walk Distance — 1137; 1195 feet — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multi Modal Balance Training (MMBI) (Behavioral); Weight Loss (WL) (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 6 Minute Walk Distance |
1137; 1195 | 0.03 sig |
| SECONDARY Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement |
13.46; 15.01 | 0.34 |
| SECONDARY Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan |
64185; 66642.5; 63251; 69376.5 | 0.78 |
| SECONDARY Change in Gait Biomechanics |
16.8; 20.3 | 0.03 sig |
| SECONDARY Change in Short Physical Performance Battery |
9; 9; 10; 11 | 0.14 |
| SECONDARY Change in Four Square Step Test |
12.58; 17.68; 10.67; 11.69 | .17 |
| SECONDARY Change in 8 Foot up and go |
9.00; 10.24; 9.78; 8.33 | 0.23 |
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 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.
Eligibility Criteria
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 /= 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 10% or frequent hypoglycemic episodes
- Currently undergoing chemotherapy and/or radiation therapy for cancer treatment
Data sourced from ClinicalTrials.gov (NCT02806336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.