Parkinson Disease
Conditions
Keywords
social support, exercise
Brief summary
This study will examine the influence of social support on exercise frequency, duration, quality of life, and overall activity level.
Detailed description
The benefits of exercise for individuals with Parkinson disease (PD) have been well documented; however, individuals with PD living in rural and underserved urban settings are largely unable or unwilling to participate in group exercise programs due in large part to their distance from such programs and financial considerations. Additionally, community based programs which provide social support and engagement have been shown to benefit elderly individuals as well as individuals with pathology, but are equally unattainable to this group. Taking the exercise to these individuals via telemedicine or tele-exercise may be an ideal means of delivering this type of intervention. The long-term goal of this project is to improve outcomes for underserved populations of individuals with Parkinson disease (PD) by providing access to in-home physical activity via a telehealth approach. Approximately one million Americans currently live with a diagnosis of PD and it has been estimated that delaying the progression by 20% would result in a $75,891 savings per individual based on reduced health care costs, income maintenance, increased duration of life and improved quality of life. However, individuals with PD of lower socioeconomic status, people of color and rural dwelling seniors have been critically underserved by clinical and academic programming resulting in poorer health outcomes. This Study will examine the effects of social engagement during in-home exercise on a small sample of individuals with Parkinson Disease (PD). This pilot investigation will directly measure the effect of social support and engagement on exercise outcomes for rural dwelling individuals with PD.
Interventions
BEHAVIORALSocial Cycling Group
engaged with a research staff member for 30 minutes of cycling
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
12 participants randomly assigned to social cycling group or solo cycling group, solo group participants crossed over to the social group.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of idiopathic definite PD based upon established criteria * vision at or corrected to 20/40 or better * ability to independently ambulate for at least 10 minutes continuously * no reported vestibular or neurological disease (stroke or muscle disease) beyond their diagnosed PD * score of greater than or equal to 78 (no evidence of dementia) on the telephone adaptation of the modified mini-mental state exam * English Speaking
Exclusion criteria
* contraindication for exercise * history of muscular or orthopedic diagnosis * inability to participate in the full duration of the study * currently exercising for 20 or more minutes per week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence: Percentage of Sessions Completed | up to 6 months of active intervention | Total number of completed sessions divided by the prescribed number of sessions per study protocol (72) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Per Session | up to 6 months of active intervention | The number of minutes spent cycling during each session |
| Adverse Events | up to 6 months of active intervention | Adverse events that occur during the active intervention period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Activity Level as Measured by Average Steps Per Day | up to 6 months | Participant will wear an activity monitor to collect this data |
| Change in Canadian Occupational Performance Measure (COPM) Scores | 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. |
| Change in Fall Frequency | 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. |
Countries
United States
Participant flow
Pre-assignment details
All participants who started the solo cycling group crossed over to the social cycling group.
Participants by arm
| Arm | Count |
|---|---|
| Solo Cycling Control 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. \[will crossover and complete the cycling intervention following the initial 6-months\] | 6 |
| Social Cycling Group Only 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 | 7 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Before Crossover to Social Group | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Solo Cycling Control Group | Total | Social Cycling Group Only |
|---|---|---|---|
| Age, Continuous | 75.3 years STANDARD_DEVIATION 3 | 72.0 years STANDARD_DEVIATION 6.8 | 68.1 years STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 13 Participants | 7 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 | 0 Participants | 0 Participants | 0 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 | 6 Participants | 13 Participants | 7 Participants |
| Region of Enrollment United States | 6 participants | 13 participants | 7 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 12 |
| other Total, other adverse events | 0 / 6 | 0 / 12 |
| serious Total, serious adverse events | 0 / 6 | 0 / 12 |
Outcome results
Primary
Adherence: Percentage of Sessions Completed
Total number of completed sessions divided by the prescribed number of sessions per study protocol (72)
Time frame: up to 6 months of active intervention
Population: 12 unique participants, 6 solo cycling group crossed over to social group
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Solo Cycling Control Group | Adherence: Percentage of Sessions Completed | 38.0 percent sessions completed |
| Social Cycling Group | Adherence: Percentage of Sessions Completed | 94.6 percent sessions completed |
Secondary
Adverse Events
Adverse events that occur during the active intervention period
Time frame: up to 6 months of active intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Solo Cycling Control Group | Adverse Events | 0 Participants |
| Social Cycling Group | Adverse Events | 0 Participants |
Secondary
Time Per Session
The number of minutes spent cycling during each session
Time frame: up to 6 months of active intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solo Cycling Control Group | Time Per Session | 16 minutes | Standard Deviation 11 |
| Social Cycling Group | Time Per Session | 27 minutes | Standard Deviation 3 |
Other Pre-specified
Change in Canadian Occupational Performance Measure (COPM) Scores
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.
Time frame: baseline, post-test (~6-months)
Other Pre-specified
Change in Fall Frequency
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.
Time frame: baseline, post-test (~6-months)
Other Pre-specified
Overall Activity Level as Measured by Average Steps Per Day
Participant will wear an activity monitor to collect this data
Time frame: up to 6 months