Trial Outcomes & Findings for Metabolic Syndrome and Fall Risk (NCT NCT02633891)
NCT ID: NCT02633891
Last Updated: 2024-06-28
Results Overview
A measure of proactive dynamic standing balance. A participant steps over four canes that are laid on the ground at 90 degree angles to each other. The participants stands in one of the squares formed by the canes and they are instructed to step as quickly as possible into each square in a specified sequence.
COMPLETED
NA
12 participants
12 weeks
2024-06-28
Participant Flow
Participant milestones
| Measure |
Balance Exercise Program
Participants will attend weekly group training sessions and will keep an exercise log of home activity during a three month exercise program designed to improve balance. Balance exercises will be performed three times per week in a home-based training program.
Balance exercise: tailored balance exercise program
|
Standard Care
Participants will meet in person on a weekly basis for a general education class regarding health and fall prevention but will not participate in an exercise class.
Standard care: general health education and fall prevention classes
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metabolic Syndrome and Fall Risk
Baseline characteristics by cohort
| Measure |
Balance Exercise Program
n=7 Participants
Participants will attend weekly group training sessions and will keep an exercise log of home activity during a three month exercise program designed to improve balance. Balance exercises will be performed three times per week in a home-based training program.
Balance exercise: tailored balance exercise program
|
Standard Care
n=5 Participants
Participants will meet in person on a weekly basis for a general education class regarding health and fall prevention but will not participate in an exercise class.
Standard care: general health education and fall prevention classes
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
66 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
35.64 kg/m^2
n=5 Participants
|
38.16 kg/m^2
n=7 Participants
|
36.69 kg/m^2
n=5 Participants
|
|
Fasting glucose
|
133.86 mg/dL
n=5 Participants
|
108.4 mg/dL
n=7 Participants
|
123.25 mg/dL
n=5 Participants
|
|
Four square step test
|
14.49 seconds
n=5 Participants
|
13.01 seconds
n=7 Participants
|
13.91 seconds
n=5 Participants
|
|
Dynamic Gait Index (DGI)
|
7 score on a scale
n=5 Participants
|
9 score on a scale
n=7 Participants
|
7.73 score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: In the balance exercise program 2 participants were lost to follow up and 2 participants did not complete the 12-week mobility testing, which included the FSST. In the standard care group 1 participant was lost to follow up.
A measure of proactive dynamic standing balance. A participant steps over four canes that are laid on the ground at 90 degree angles to each other. The participants stands in one of the squares formed by the canes and they are instructed to step as quickly as possible into each square in a specified sequence.
Outcome measures
| Measure |
Balance Exercise Program
n=3 Participants
Participants will attend weekly group training sessions and will keep an exercise log of home activity during a three month exercise program designed to improve balance. Balance exercises will be performed three times per week in a home-based training program.
Balance exercise: tailored balance exercise program
|
Standard Care
n=4 Participants
Participants will meet in person on a weekly basis for a general education class regarding health and fall prevention but will not participate in an exercise class.
Standard care: general health education and fall prevention classes
|
|---|---|---|
|
Four Square Step Test (FSST)
|
11.04 seconds
Interval 9.9 to 12.93
|
14.29 seconds
Interval 9.28 to 25.47
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: In the balance exercise program 2 participants were lost to follow up and 2 participants did not complete the 12-week mobility testing, which included the DGI. In the standard care group 1 participant was lost to follow up.
An instrumented DGI will be performed on an instrumented gait mat. The DGI is a measure of functional balance during walking and it assesses an individual's ability to modify balance while walking in the presence of external demands (walking while changing speeds, head turns, stepping over and around obstacles, pivoting, and stair climbing). The short form DGI is scored 0-12, with higher number indicating better performance.
Outcome measures
| Measure |
Balance Exercise Program
n=3 Participants
Participants will attend weekly group training sessions and will keep an exercise log of home activity during a three month exercise program designed to improve balance. Balance exercises will be performed three times per week in a home-based training program.
Balance exercise: tailored balance exercise program
|
Standard Care
n=4 Participants
Participants will meet in person on a weekly basis for a general education class regarding health and fall prevention but will not participate in an exercise class.
Standard care: general health education and fall prevention classes
|
|---|---|---|
|
Dynamic Gait Index (DGI)
|
9.33 score on a scale
Interval 8.0 to 10.0
|
7.5 score on a scale
Interval 3.0 to 11.0
|
Adverse Events
Balance Exercise Program
Standard Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place