Trial Outcomes & Findings for Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility (NCT NCT02806336)
NCT ID: NCT02806336
Last Updated: 2025-04-09
Results Overview
Distance walked during the 6 minute walking test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
6 months
Results posted on
2025-04-09
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
COVID-19 research shut down
|
3
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
Multimodel Exercise and Weight Loss in Older Obese Veterans With Dysmobility
Baseline characteristics by cohort
| Measure |
Multi Modal Balance Training & Weight Loss
n=9 Participants
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
|
Multi Modal Balance Training Only
n=11 Participants
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
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Continuous
|
70.44 years
STANDARD_DEVIATION 8.50 • n=99 Participants
|
71.73 years
STANDARD_DEVIATION 5.37 • n=107 Participants
|
71.15 years
STANDARD_DEVIATION 6.78 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Body Mass Index (BMI) (kg/m2)
|
37.72 kg/m2
STANDARD_DEVIATION 4.84 • n=99 Participants
|
36.65 kg/m2
STANDARD_DEVIATION 5.02 • n=107 Participants
|
37.18 kg/m2
STANDARD_DEVIATION 4.82 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
Distance walked during the 6 minute walking test
Outcome measures
| Measure |
Multi Modal Balance Training & Weight Loss
n=9 Participants
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
|
Multi Modal Balance Training Only
n=9 Participants
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
|
|---|---|---|
|
Change in 6 Minute Walk Distance
|
1137 feet
Standard Deviation 328
|
1195 feet
Standard Deviation 425
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were certain circumstances in which the Principal Investigator or clinical investigative team chose not to perform some of the research procedures.
6 minute walk with submaximal assessment of oxygen uptake as a measure of fitness.
Outcome measures
| Measure |
Multi Modal Balance Training & Weight Loss
n=9 Participants
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
|
Multi Modal Balance Training Only
n=9 Participants
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
|
|---|---|---|
|
Change in 6 Minute Walk With Oxygen Uptake (VO2) Measurement
|
13.46 ml/kg/min
Standard Deviation 4.04
|
15.01 ml/kg/min
Standard Deviation 3.64
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: 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.
The DXA scan provides information about the body composition including total body fat, and lean muscle mass
Outcome measures
| Measure |
Multi Modal Balance Training & Weight Loss
n=7 Participants
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
|
Multi Modal Balance Training Only
n=6 Participants
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
|
|---|---|---|
|
Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan
Baseline
|
64185 grams
Standard Deviation 15175.8
|
66642.5 grams
Standard Deviation 4653.3
|
|
Change in Lean Mass as Assessed by Dual Energy X Ray Absorptiometry (DXA) Scan
6 months
|
63251 grams
Standard Deviation 14811.1
|
69376.5 grams
Standard Deviation 4599.7
|
SECONDARY outcome
Timeframe: 6 monthsGait biomechanics as assessed by walking mechanics on the gait rite mat. Scale range 0 - 24 with higher scores indicating better outcome.
Outcome measures
| Measure |
Multi Modal Balance Training & Weight Loss
n=9 Participants
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
|
Multi Modal Balance Training Only
n=9 Participants
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
|
|---|---|---|
|
Change in Gait Biomechanics
|
16.8 score on a scale
Standard Deviation 6
|
20.3 score on a scale
Standard Deviation 7
|
SECONDARY outcome
Timeframe: baseline, 3 monthsPopulation: 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.
overall short physical performance battery score. Scale range 0 - 12 with higher scores indicating better possible function.
Outcome measures
| Measure |
Multi Modal Balance Training & Weight Loss
n=7 Participants
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
|
Multi Modal Balance Training Only
n=7 Participants
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
|
|---|---|---|
|
Change in Short Physical Performance Battery
Baseline
|
9 units on a scale
Standard Deviation 2
|
9 units on a scale
Standard Deviation 3
|
|
Change in Short Physical Performance Battery
3 months
|
10 units on a scale
Standard Deviation 2
|
11 units on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: baseline, 3 monthsPopulation: 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.
Dynamic test of balance involving change in stepping direction.
Outcome measures
| Measure |
Multi Modal Balance Training & Weight Loss
n=7 Participants
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
|
Multi Modal Balance Training Only
n=7 Participants
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
|
|---|---|---|
|
Change in Four Square Step Test
3 months
|
10.67 seconds
Standard Deviation 1.63
|
11.69 seconds
Standard Deviation 4.14
|
|
Change in Four Square Step Test
Baseline
|
12.58 seconds
Standard Deviation 3.06
|
17.68 seconds
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: baseline, 3 monthsPopulation: 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.
Time to get up from a chair and walk around a cone 8 feet away and sit back down, representing agility.
Outcome measures
| Measure |
Multi Modal Balance Training & Weight Loss
n=7 Participants
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
|
Multi Modal Balance Training Only
n=7 Participants
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
|
|---|---|---|
|
Change in 8 Foot up and go
Baseline
|
9.00 seconds
Standard Deviation 2.61
|
10.24 seconds
Standard Deviation 3.12
|
|
Change in 8 Foot up and go
3 months
|
9.78 seconds
Standard Deviation 2.82
|
8.33 seconds
Standard Deviation 2.34
|
Adverse Events
Multi Modal Balance Training & Weight Loss
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Multi Modal Balance Training Only
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Multi Modal Balance Training & Weight Loss
n=9 participants at risk
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
|
Multi Modal Balance Training Only
n=11 participants at risk
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
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
44.4%
4/9 • Number of events 4 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
18.2%
2/11 • Number of events 6 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
|
Musculoskeletal and connective tissue disorders
Carpal Tunnel Surgery
|
11.1%
1/9 • Number of events 1 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
0.00%
0/11 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
|
General disorders
Car accident
|
11.1%
1/9 • Number of events 1 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
0.00%
0/11 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
|
Musculoskeletal and connective tissue disorders
Right knee swelling
|
11.1%
1/9 • Number of events 1 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
0.00%
0/11 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
|
Eye disorders
Conjunctivitis
|
11.1%
1/9 • Number of events 1 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
0.00%
0/11 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
|
Musculoskeletal and connective tissue disorders
Back/hip pain
|
0.00%
0/9 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
18.2%
2/11 • Number of events 2 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/9 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
9.1%
1/11 • Number of events 1 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/9 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
9.1%
1/11 • Number of events 1 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/9 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
9.1%
1/11 • Number of events 1 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
|
Hepatobiliary disorders
Hypoglycemia
|
0.00%
0/9 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
9.1%
1/11 • Number of events 1 • Up to 2 years
The definitions of adverse events and serious adverse events does not differ from the clinical trials definitions.
|
Additional Information
Dr. Leslie Katzel
Baltimore VA Geriatric Research Education and Clinical Center
Phone: 4106057248
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place