Dysmobility, Obesity
Conditions
Keywords
exercise training, assistive device, weight loss, function, mobility
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.
Interventions
BEHAVIORALMulti Modal Balance Training (MMBI)
Group balance class, obstacle course, strengthening exercises
BEHAVIORALWeight Loss (WL)
Nutritional counseling to achieve 500 kcal standard hypocaloric diet
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessor blinded to group, statistical analyses blinded to group
Intervention model description
Two group randomized control trial (RCT)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 Minute Walk Distance | 6 months | Distance walked during the 6 minute walking test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan | baseline, 6 months | The DXA scan provides information about the body composition including total body fat, and lean muscle mass |
| Change in Gait Biomechanics | 6 months | Gait biomechanics as assessed by walking mechanics on the gait rite mat. Scale range 0 - 24 with higher scores indicating better outcome. |
| Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement | 6 months | 6 minute walk with submaximal assessment of oxygen uptake as a measure of fitness. |
| Change in Four Square Step Test | baseline, 3 months | Dynamic test of balance involving change in stepping direction. |
| Change in 8 Foot up and go | baseline, 3 months | Time to get up from a chair and walk around a cone 8 feet away and sit back down, representing agility. |
| Change in Short Physical Performance Battery | baseline, 3 months | overall short physical performance battery score. Scale range 0 - 12 with higher scores indicating better possible function. |
Countries
United States
Participant flow
Pre-assignment details
Subjects were excluded from the study before assignment to groups due to the corona virus 19 (COVID-19) pandemic and associated research activity shut down.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Multi Modal Balance Training: Group balance class, obstacle course, strengthening exercises
Weight Loss: Nutritional counseling to achieve 500 kcal standard hypocaloric diet | 9 |
| 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).
Multi Modal Balance Training: Group balance class, obstacle course, strengthening exercises | 11 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | COVID-19 research shut down | 3 | 4 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Multi Modal Balance Training & Weight Loss | Multi Modal Balance Training Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 10 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Continuous | 70.44 years STANDARD_DEVIATION 8.5 | 71.73 years STANDARD_DEVIATION 5.37 | 71.15 years STANDARD_DEVIATION 6.78 |
| Body Mass Index (BMI) (kg/m2) | 37.72 kg/m2 STANDARD_DEVIATION 4.84 | 36.65 kg/m2 STANDARD_DEVIATION 5.02 | 37.18 kg/m2 STANDARD_DEVIATION 4.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 11 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 7 Participants | 11 Participants |
| Region of Enrollment United States | 9 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 11 |
| other Total, other adverse events | 6 / 9 | 5 / 11 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 |
Outcome results
Primary
Change in 6 Minute Walk Distance
Distance walked during the 6 minute walking test
Time frame: 6 months
Population: There may have been certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures or there may have been unforeseen problems with data collection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multi Modal Balance Training & Weight Loss | Change in 6 Minute Walk Distance | 1137 feet | Standard Deviation 328 |
| Multi Modal Balance Training Only | Change in 6 Minute Walk Distance | 1195 feet | Standard Deviation 425 |
Comparison: change in combined groupsp-value: 0.03t-test, 2 sided
Secondary
Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement
6 minute walk with submaximal assessment of oxygen uptake as a measure of fitness.
Time frame: 6 months
Population: There were certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multi Modal Balance Training & Weight Loss | Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement | 13.46 ml/kg/min | Standard Deviation 4.04 |
| Multi Modal Balance Training Only | Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement | 15.01 ml/kg/min | Standard Deviation 3.64 |
p-value: 0.34t-test, 2 sided
Secondary
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.
Time frame: baseline, 3 months
Population: There may have been certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures or there may have been unforeseen problems with data collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multi Modal Balance Training & Weight Loss | Change in 8 Foot up and go | Baseline | 9.00 seconds | Standard Deviation 2.61 |
| Multi Modal Balance Training & Weight Loss | Change in 8 Foot up and go | 3 months | 9.78 seconds | Standard Deviation 2.82 |
| Multi Modal Balance Training Only | Change in 8 Foot up and go | Baseline | 10.24 seconds | Standard Deviation 3.12 |
| Multi Modal Balance Training Only | Change in 8 Foot up and go | 3 months | 8.33 seconds | Standard Deviation 2.34 |
p-value: 0.23t-test, 2 sided
Secondary
Change in Four Square Step Test
Dynamic test of balance involving change in stepping direction.
Time frame: baseline, 3 months
Population: There may have been certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures or there may have been unforeseen problems with data collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multi Modal Balance Training & Weight Loss | Change in Four Square Step Test | Baseline | 12.58 seconds | Standard Deviation 3.06 |
| Multi Modal Balance Training & Weight Loss | Change in Four Square Step Test | 3 months | 10.67 seconds | Standard Deviation 1.63 |
| Multi Modal Balance Training Only | Change in Four Square Step Test | Baseline | 17.68 seconds | Standard Deviation 6.4 |
| Multi Modal Balance Training Only | Change in Four Square Step Test | 3 months | 11.69 seconds | Standard Deviation 4.14 |
p-value: 0.17t-test, 2 sided
p-value: 0.14t-test, 2 sided
Secondary
Change in Gait Biomechanics
Gait biomechanics as assessed by walking mechanics on the gait rite mat. Scale range 0 - 24 with higher scores indicating better outcome.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multi Modal Balance Training & Weight Loss | Change in Gait Biomechanics | 16.8 score on a scale | Standard Deviation 6 |
| Multi Modal Balance Training Only | Change in Gait Biomechanics | 20.3 score on a scale | Standard Deviation 7 |
p-value: 0.03t-test, 2 sided
Secondary
Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan
The DXA scan provides information about the body composition including total body fat, and lean muscle mass
Time frame: baseline, 6 months
Population: There may have been certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures or there may have been unforeseen problems with data collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multi Modal Balance Training & Weight Loss | Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan | Baseline | 64185 grams | Standard Deviation 15175.8 |
| Multi Modal Balance Training & Weight Loss | Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan | 6 months | 63251 grams | Standard Deviation 14811.1 |
| Multi Modal Balance Training Only | Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan | Baseline | 66642.5 grams | Standard Deviation 4653.3 |
| Multi Modal Balance Training Only | Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan | 6 months | 69376.5 grams | Standard Deviation 4599.7 |
p-value: 0.78t-test, 2 sided
Secondary
Change in Short Physical Performance Battery
overall short physical performance battery score. Scale range 0 - 12 with higher scores indicating better possible function.
Time frame: baseline, 3 months
Population: There may have been certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures or there may have been unforeseen problems with data collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multi Modal Balance Training & Weight Loss | Change in Short Physical Performance Battery | Baseline | 9 units on a scale | Standard Deviation 2 |
| Multi Modal Balance Training & Weight Loss | Change in Short Physical Performance Battery | 3 months | 10 units on a scale | Standard Deviation 2 |
| Multi Modal Balance Training Only | Change in Short Physical Performance Battery | Baseline | 9 units on a scale | Standard Deviation 3 |
| Multi Modal Balance Training Only | Change in Short Physical Performance Battery | 3 months | 11 units on a scale | Standard Deviation 2 |
p-value: 0.14t-test, 2 sided