Trial Outcomes & Findings for In-home Cycling for Individuals With PD: Feasibility (NCT NCT04300023)
NCT ID: NCT04300023
Last Updated: 2025-02-04
Results Overview
Total number of completed sessions divided by the prescribed number of sessions per study protocol (72)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
up to 6 months of active intervention
Results posted on
2025-02-04
Participant Flow
All participants who started the solo cycling group crossed over to the social cycling group.
Participant milestones
| Measure |
Solo Cycling Control Group
Solo Cycling Group: Exercise bike delivered to their home, custom fit to their needs and installed in a safe location. Participants will be provided with exercise recommendations, but will receive only data recording calls every 2-weeks. \[will crossover and complete the cycling intervention following the initial 6-months\]
|
Social Cycling Group
Exercise bike delivered to their home, custom fit to their needs and installed in a safe location, sessions will consist of up to 30 minutes of cycling while engaged in social interaction with a research staff member, thus providing a social/community aspect that would not otherwise be present.
Social Cycling Group: engaged with a research staff member for 30 minutes of cycling
|
|---|---|---|
|
Before Crossover to Social Group
STARTED
|
6
|
7
|
|
Before Crossover to Social Group
COMPLETED
|
6
|
6
|
|
Before Crossover to Social Group
NOT COMPLETED
|
0
|
1
|
|
After Crossover to Social Group
STARTED
|
6
|
0
|
|
After Crossover to Social Group
COMPLETED
|
6
|
0
|
|
After Crossover to Social Group
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Solo Cycling Control Group
Solo Cycling Group: Exercise bike delivered to their home, custom fit to their needs and installed in a safe location. Participants will be provided with exercise recommendations, but will receive only data recording calls every 2-weeks. \[will crossover and complete the cycling intervention following the initial 6-months\]
|
Social Cycling Group
Exercise bike delivered to their home, custom fit to their needs and installed in a safe location, sessions will consist of up to 30 minutes of cycling while engaged in social interaction with a research staff member, thus providing a social/community aspect that would not otherwise be present.
Social Cycling Group: engaged with a research staff member for 30 minutes of cycling
|
|---|---|---|
|
Before Crossover to Social Group
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
In-home Cycling for Individuals With PD: Feasibility
Baseline characteristics by cohort
| Measure |
Solo Cycling Control Group
n=6 Participants
Exercise bike delivered to their home, custom fit to their needs and installed in a safe location. Participants will be provided with exercise recommendations, but will receive only data recording calls every 2-weeks. \[will crossover and complete the cycling intervention following the initial 6-months\]
|
Social Cycling Group Only
n=7 Participants
Exercise bike delivered to their home, custom fit to their needs and installed in a safe location, sessions will consist of up to 30 minutes of cycling while engaged in social interaction with a research staff member, thus providing a social/community aspect that would not otherwise be present.
Social Cycling Group: engaged with a research staff member for 30 minutes of cycling
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.3 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
68.1 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
72.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 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
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 6 months of active interventionPopulation: 12 unique participants, 6 solo cycling group crossed over to social group
Total number of completed sessions divided by the prescribed number of sessions per study protocol (72)
Outcome measures
| Measure |
Solo Cycling Control Group
n=432 sessions
Exercise bike delivered to their home, custom fit to their needs and installed in a safe location. Participants will be provided with exercise recommendations, but will receive only data recording calls every 2-weeks. \[will crossover and complete the cycling intervention following the initial 6-months\]
|
Social Cycling Group
n=864 sessions
Exercise bike delivered to their home, custom fit to their needs and installed in a safe location, sessions will consist of up to 30 minutes of cycling while engaged in social interaction with a research staff member, thus providing a social/community aspect that would not otherwise be present.
Social Cycling Group: engaged with a research staff member for 30 minutes of cycling
|
|---|---|---|
|
Adherence: Percentage of Sessions Completed
|
38.0 percent sessions completed
Interval 7.0 to 75.0
|
94.6 percent sessions completed
Interval 88.9 to 98.6
|
SECONDARY outcome
Timeframe: up to 6 months of active interventionThe number of minutes spent cycling during each session
Outcome measures
| Measure |
Solo Cycling Control Group
n=6 Participants
Exercise bike delivered to their home, custom fit to their needs and installed in a safe location. Participants will be provided with exercise recommendations, but will receive only data recording calls every 2-weeks. \[will crossover and complete the cycling intervention following the initial 6-months\]
|
Social Cycling Group
n=12 Participants
Exercise bike delivered to their home, custom fit to their needs and installed in a safe location, sessions will consist of up to 30 minutes of cycling while engaged in social interaction with a research staff member, thus providing a social/community aspect that would not otherwise be present.
Social Cycling Group: engaged with a research staff member for 30 minutes of cycling
|
|---|---|---|
|
Time Per Session
|
16 minutes
Standard Deviation 11
|
27 minutes
Standard Deviation 3
|
SECONDARY outcome
Timeframe: up to 6 months of active interventionAdverse events that occur during the active intervention period
Outcome measures
| Measure |
Solo Cycling Control Group
n=6 Participants
Exercise bike delivered to their home, custom fit to their needs and installed in a safe location. Participants will be provided with exercise recommendations, but will receive only data recording calls every 2-weeks. \[will crossover and complete the cycling intervention following the initial 6-months\]
|
Social Cycling Group
n=12 Participants
Exercise bike delivered to their home, custom fit to their needs and installed in a safe location, sessions will consist of up to 30 minutes of cycling while engaged in social interaction with a research staff member, thus providing a social/community aspect that would not otherwise be present.
Social Cycling Group: engaged with a research staff member for 30 minutes of cycling
|
|---|---|---|
|
Adverse Events
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 monthsParticipant will wear an activity monitor to collect this data
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, post-test (~6-months)The Canadian Occupational Performance Measure (COPM) will be administered to assess the participant's self-report of performance and satisfaction on a scale of 1 to 10 on self-selected occupational tasks. Performance and satisfaction scores range from 1 (lowest) to 10 (highest) for each identified item. The top three identified occupations will be reported.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, post-test (~6-months)The Fall History Questionnaire is a 6-item survey that asks about Fall rate in the last 2 weeks, last month, last 6 months, the typical cause of a fall, and how the fear of falling may influence daily activities. The hypothesis is that Fall frequency will be improved in the socially engaged cycling group and not with those cycling alone.
Outcome measures
Outcome data not reported
Adverse Events
Solo Cycling Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Social Cycling Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kristen Pickett, PhD
University of Wisconsin - Madison
Phone: (608) 890-2103
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place