Clinical trial NCT02806336: Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility
Official title: Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Dysmobility
Keywords: exercise training
assistive device
weight loss
function
mobility
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-06-20
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group randomized control trial (RCT)
Primary purpose: TREATMENT

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 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.

Detailed description: 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.

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 \< 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

Primary outcomes:
measure: Change in 6 Minute Walk Distance
timeFrame: 6 months
Secondary outcomes:
measure: Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement
timeFrame: 6 months
measure: Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan
timeFrame: baseline, 6 months
measure: Change in Gait Biomechanics
timeFrame: 6 months
measure: Change in Short Physical Performance Battery
timeFrame: baseline, 3 months
measure: Change in Four Square Step Test
timeFrame: baseline, 3 months
measure: Change in 8 Foot up and go
timeFrame: baseline, 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Leslie I Katzel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: