In-home Cycling for Individuals With PD: Effectiveness

NCT06616948 | Completed DMC

• 3 other identifiers: 2018-0414: EffectivenessA176000EDUC\KINESIOLOGY\KINESIO
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to examine the reach and maintenance of an in-home cycling program for underserved individuals with Parkinson disease and to determine the effectiveness of a 6-month in-home, progressive, tele-exercise cycling program and 3-month health coach follow-up for those same participants.

Conditions

Parkinson Disease

Keywords

social support; exercise

Outcome Measures

Primary Outcomes (1)

• 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 averages for each of the top three occupational tasks will be reported.

  baseline, post-test (~6-months), 3-month follow up (~9-months)

Secondary Outcomes (8)

• Change in Pittsburgh Sleep Quality Index

  baseline, post-test (~6-months), 3-month follow up (~9-months)

• Change in Timed Up and Go Test

  baseline, post-test (~6-months), 3-month follow up (~9-months)

• Change in Four Square Step Test

  baseline, post-test (~6-months), 3-month follow up (~9-months)

• Change in Fall Frequency

  baseline, post-test (~6-months), 3-month follow up (~9-months)

• Change in Standardized Gait Analysis: Gait Velocity

  baseline, post-test (~6-months), 3-month follow up (~9-months)

Other Outcomes (5)

• Change in Free Locomotion Gait Analysis: Time

  baseline, post-test (~6-months), 3-month follow up (~9-months)

• Change in Free Locomotion Gait Analysis: Acceleration

  baseline, post-test (~6-months), 3-month follow up (~9-months)

• Change in Free Locomotion Gait Analysis: Angular Velocity

  baseline, post-test (~6-months), 3-month follow up (~9-months)

Study Arms (4)

Social Cycling Group

EXPERIMENTAL

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.

Behavioral: Social Cycling Group

Normal care control

NO INTERVENTION

Participants assigned to the normal care control will receive no intervention for the first 6-months then cross over to the cycling intervention.

Biweekly health coach

EXPERIMENTAL

Following completion of the 6-month cycling intervention, participants will receive a call every 2-weeks to discuss ongoing maintenance efforts.

Behavioral: coaching calls

No health coach

ACTIVE COMPARATOR

Following the conclusion of the 6-month cycling session, participants will be contacted monthly to record falls. No discussion of ongoing exercise will occur

Behavioral: No coaching calls

Interventions

Social Cycling Group BEHAVIORAL

engaged with a research staff member for 30 minutes of cycling

Social Cycling Group

coaching calls BEHAVIORAL

individuals will receive a phone call every 14 days to discuss ongoing exercise maintenance efforts.

Biweekly health coach

No coaching calls BEHAVIORAL

Following completion of the 6-month cycling sessions, no maintenance calls will be placed.

No health coach

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Kristen A Pickett, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed pilot study will utilize the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation and Maintenance) to focus on the reach and effectiveness of a 6-month triweekly in-home cycling program and then pilot a health coach model to promote maintenance for the subsequent 3-month period.

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: August 25, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)