In-home Cycling for Individuals With PD: Feasibility

NCT04300023 | Completed Results DMC

• 5 other identifiers: 2018-0414: FeasibilityA176000EDUC\KINESIOLOGY\KINESIO1UL1TR002373-011KL2TR002374-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the influence of social support on exercise frequency, duration, quality of life, and overall activity level.

Conditions

Parkinson Disease

Keywords

social support; exercise

Outcome Measures

Primary Outcomes (1)

• Adherence: Percentage of Sessions Completed

  Total number of completed sessions divided by the prescribed number of sessions per study protocol (72)

  up to 6 months of active intervention

Secondary Outcomes (2)

• Time Per Session

  up to 6 months of active intervention

• Adverse Events

  up to 6 months of active intervention

Other Outcomes (3)

• Overall Activity Level as Measured by Average Steps Per Day

  up to 6 months

• Change in Canadian Occupational Performance Measure (COPM) Scores

  baseline, post-test (~6-months)

• Change in Fall Frequency

  baseline, post-test (~6-months)

Study Arms (2)

Solo Cycling Control Group

NO INTERVENTION

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

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

Interventions

Social Cycling Group BEHAVIORAL

engaged with a research staff member for 30 minutes of cycling

Social Cycling Group

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
• National Center for Advancing Translational Sciences (NCATS): collaborator

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

Results Point of Contact

• Title: Kristen Pickett, PhD
• Organization: University of Wisconsin - Madison

Kristen.pickett@wisc.edu

(608) 890-2103

Study Officials

• Kristen A Pickett, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: 12 participants randomly assigned to social cycling group or solo cycling group, solo group participants crossed over to the social group.

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: August 25, 2021
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)