Trial Outcomes & Findings for Highly Challenging Balance Program to Reduce Fall Rate in PD (NCT NCT03972969)
NCT ID: NCT03972969
Last Updated: 2024-06-21
Results Overview
Total number of falls from baseline to the 3-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
162 participants
Primary outcome timeframe
Baseline to 3 months
Results posted on
2024-06-21
Participant Flow
Participant milestones
| Measure |
In-person Exercise Group
facility-based structured exercise program
Facility-based structured exercise: Structured exercise program in a facility with instruction and encouragement
|
Remote Exercise Group
home-based structured exercise program
Home-based structured exercise: Structured exercise program in the home with instruction and encouragement
|
Control Group
health education
Health education: Provision of general information about a variety of topics
|
|---|---|---|---|
|
3-month Follow-up
STARTED
|
51
|
58
|
53
|
|
3-month Follow-up
COMPLETED
|
50
|
57
|
53
|
|
3-month Follow-up
NOT COMPLETED
|
1
|
1
|
0
|
|
6-month Follow-up
STARTED
|
50
|
57
|
53
|
|
6-month Follow-up
COMPLETED
|
47
|
54
|
50
|
|
6-month Follow-up
NOT COMPLETED
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
In-person Exercise Group
facility-based structured exercise program
Facility-based structured exercise: Structured exercise program in a facility with instruction and encouragement
|
Remote Exercise Group
home-based structured exercise program
Home-based structured exercise: Structured exercise program in the home with instruction and encouragement
|
Control Group
health education
Health education: Provision of general information about a variety of topics
|
|---|---|---|---|
|
3-month Follow-up
Death
|
1
|
1
|
0
|
|
6-month Follow-up
Death
|
1
|
1
|
1
|
|
6-month Follow-up
Lost to Follow-up
|
2
|
2
|
2
|
Baseline Characteristics
Highly Challenging Balance Program to Reduce Fall Rate in PD
Baseline characteristics by cohort
| Measure |
In-person Exercise Group
n=51 Participants
facility-based structured exercise program
Facility-based structured exercise: Structured exercise program in a facility with instruction and encouragement
|
Remote Exercise Group
n=58 Participants
home-based structured exercise program
Home-based structured exercise: Structured exercise program in the home with instruction and encouragement
|
Control Group
n=53 Participants
health education
Health education: Provision of general information about a variety of topics
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.5 years
STANDARD_DEVIATION 7.0 • n=99 Participants
|
76.2 years
STANDARD_DEVIATION 7.2 • n=107 Participants
|
73.2 years
STANDARD_DEVIATION 7.7 • n=206 Participants
|
74.4 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
160 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White Non-Hispanic
|
51 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
160 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsTotal number of falls from baseline to the 3-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.
Outcome measures
| Measure |
In-person Exercise Group
n=51 Participants
facility-based structured exercise program
Facility-based structured exercise: Structured exercise program in a facility with instruction and encouragement
|
Remote Exercise Group
n=58 Participants
home-based structured exercise program
Home-based structured exercise: Structured exercise program in the home with instruction and encouragement
|
Control Group
n=53 Participants
health education
Health education: Provision of general information about a variety of topics
|
|---|---|---|---|
|
Number of Falls Over 3 Month Period
|
1.1 number of falls
Standard Deviation 2.7
|
1.6 number of falls
Standard Deviation 3.0
|
9.7 number of falls
Standard Deviation 48.4
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsTotal number of falls from baseline to the 6-month follow-up. Falls are defined as unexpected events in which the participants come to rest on the ground, floor, or lower level.
Outcome measures
| Measure |
In-person Exercise Group
n=51 Participants
facility-based structured exercise program
Facility-based structured exercise: Structured exercise program in a facility with instruction and encouragement
|
Remote Exercise Group
n=58 Participants
home-based structured exercise program
Home-based structured exercise: Structured exercise program in the home with instruction and encouragement
|
Control Group
n=53 Participants
health education
Health education: Provision of general information about a variety of topics
|
|---|---|---|---|
|
Number of Falls Over 6 Month Period
|
2.08 number of falls
Standard Deviation 3.46
|
3.02 number of falls
Standard Deviation 6.32
|
11.36 number of falls
Standard Deviation 49.55
|
Adverse Events
In-person Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Remote Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
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