In-home Cycling for Parkinson's Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Muscular, Orthopedic, Exercise, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

40 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment In-home Cycling for Parkinson's Disease?

Research shows that cycling, including in-home and community-based programs, can help improve symptoms of Parkinson's disease. Studies found that regular cycling can lead to better motor function, balance, and coordination, and may slow disease progression. ^{1 2 3 4 5}

Is in-home cycling safe for people with Parkinson's disease?

The research on cycling for Parkinson's disease does not report specific safety concerns or adverse events, suggesting it is generally safe. However, many studies did not report on adverse events, so it's important to consult with a healthcare provider before starting any new exercise program. ^{2 4 5 6 7}

How does in-home cycling treatment differ from other treatments for Parkinson's disease?

In-home cycling for Parkinson's disease is unique because it allows patients to engage in exercise at home, potentially increasing accessibility and adherence compared to facility-based programs. This treatment focuses on high-cadence cycling, which has been shown to improve motor symptoms like tremor and bradykinesia (slowness of movement) in Parkinson's patients, offering a non-drug approach to managing symptoms. ^{2 3 5 6 8}

What is the purpose of this trial?

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.

Research Team

Kristen A Pickett, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for individuals with Parkinson's Disease who are underserved and interested in an at-home cycling program. Participants will engage in a 6-month tele-exercise cycling routine, followed by a 3-month period with optional health coaching.

Inclusion Criteria

I have been diagnosed with Parkinson's disease.

My vision is 20/40 or better, with or without glasses.

English speaking

Exclusion Criteria

Contraindication for exercise

I can commit to the full duration of the study.

Currently exercising for 20 or more minutes per week

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-month in-home, progressive, tele-exercise cycling program with social interaction via Skype

6 months

Regular virtual sessions via Skype

Follow-up

Participants receive a 3-month follow-up with a health coach to discuss maintenance efforts and motivation

3 months

Biweekly calls with health coach

Follow-up (No Health Coach)

Participants are contacted monthly to record falls, with no discussion of ongoing exercise

3 months

Monthly contact for fall recording

Treatment Details

Interventions

• In-home Cycling

Trial Overview The study tests the effectiveness of two approaches: one group participates in social cycling sessions along with regular coaching calls, while another group cycles without any coaching calls.

Participant Groups

Group I: Social Cycling Group Experimental Treatment 1 Intervention

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.

Group II: Biweekly health coach Experimental Treatment 1 Intervention

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

Group III: Normal care control Active Control 1 Intervention

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

Group IV: No health coach Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Findings from Research

Persons with Parkinson's disease (PD) and age-matched healthy adults both increased their pedaling rates while cycling in a virtual environment (VE) with auditory and visual cues, indicating that these cues can effectively enhance exercise intensity.

However, individuals with PD needed explicit instructions to focus on visual cues to increase their cycling speed, suggesting that attention to cues is crucial for this group to benefit from the exercise intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory and visual cueing modulate cycling speed of older adults and persons with Parkinson's disease in a Virtual Cycling (V-Cycle) system. Gallagher, R., Damodaran, H., Werner, WG., et al.[2018]

In a 6-month community-based cycling program for 41 participants with Parkinson's disease, significant improvements were observed in motor function, as indicated by a decrease in the MDS-UPDRS-III score, suggesting that aerobic exercise can help slow disease progression.

Participants who attended at least 74% of the cycling classes experienced the greatest benefits, highlighting the importance of consistent exercise attendance and maintaining a higher pedaling cadence for mitigating Parkinson's symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based high-intensity cycling improves disease symptoms in individuals with Parkinson's disease: A six-month pragmatic observational study. Rosenfeldt, AB., Miller Koop, M., Penko, AL., et al.[2023]

Passive leg cycling significantly reduces tremor and bradykinesia in individuals with mild-to-moderate Parkinson's disease, indicating a potential therapeutic benefit for upper extremity motor function.

The rate of passive cycling (60, 70, or 80 rpm) did not influence the level of improvement in motor function, suggesting that the benefits of passive cycling may be consistent regardless of speed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of passive leg cycling on upper extremity tremor and bradykinesia in Parkinson's disease. Ridgel, AL., Muller, MD., Kim, CH., et al.[2011]

A pilot trial involving 10 individuals with Parkinson's disease demonstrated that a 40-minute session of active-assisted cycling (AAC) was well tolerated and did not cause excessive fatigue.

Most participants experienced immediate improvements in tremor and bradykinesia after the AAC session, suggesting that high-intensity cycling could be an effective intervention for enhancing motor function in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active-assisted cycling improves tremor and bradykinesia in Parkinson's disease. Ridgel, AL., Peacock, CA., Fickes, EJ., et al.[2022]

A review of 53 randomized controlled trials on exercise and motor training for Parkinson's disease showed that most interventions were effective and well-supervised, lasting an average of 8.3 weeks, with high participant retention rates (69% retained ≥85% of participants).

However, the lack of detailed reporting on adherence and adverse events in 72% of trials may hinder clinicians' ability to implement these programs effectively in practice, as they need to weigh the benefits against potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and motor training in people with Parkinson's disease: a systematic review of participant characteristics, intervention delivery, retention rates, adherence, and adverse events in clinical trials. Allen, NE., Sherrington, C., Suriyarachchi, GD., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Immediate Effects of High-Cadence Cycling on Core Outcomes in Individuals With Parkinson's Disease. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effects of a low-resistance, interval bicycling intervention in Parkinson's Disease. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Auditory and visual cueing modulate cycling speed of older adults and persons with Parkinson's disease in a Virtual Cycling (V-Cycle) system. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Community-based high-intensity cycling improves disease symptoms in individuals with Parkinson's disease: A six-month pragmatic observational study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Acute effects of passive leg cycling on upper extremity tremor and bradykinesia in Parkinson's disease. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Active-assisted cycling improves tremor and bradykinesia in Parkinson's disease. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Exercise and motor training in people with Parkinson's disease: a systematic review of participant characteristics, intervention delivery, retention rates, adherence, and adverse events in clinical trials. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A Tandem Cycling Program: Feasibility and Physical Performance Outcomes in People With Parkinson Disease. [2022]