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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cycling at home can benefit people with Parkinson's disease, particularly those without access to other exercise programs. Participants will use an exercise bike at home for six months, with some receiving regular calls from a health coach for support afterward. The study aims to determine if this program can improve participants' health and maintain benefits over time. Individuals with Parkinson's who can see well, walk independently for at least 10 minutes, and are not currently exercising more than 20 minutes a week might be suitable candidates. As an unphased trial, this study provides a unique opportunity for participants to contribute to research that could improve exercise accessibility for Parkinson's patients.

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 prior data suggests that this in-home cycling program is safe for individuals with Parkinson's disease?

Research has shown that cycling at home is generally safe for people with Parkinson’s disease. Studies have found no specific safety concerns or negative effects linked to this type of exercise, indicating that most people handle it well. In fact, cycling can enhance the overall quality of life for those with Parkinson’s. Participants in these studies experienced the benefits of exercise without major problems, making it a promising option for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores in-home cycling as a unique approach to managing Parkinson's disease. Traditional treatments often focus on medication and clinical therapies, but this method emphasizes physical activity combined with social interaction. The social cycling group is particularly innovative, as it integrates exercise with social engagement, potentially enhancing both physical and mental health. Additionally, the biweekly health coach calls aim to provide ongoing support, which could help maintain long-term benefits. This trial could reveal new ways to improve quality of life for those with Parkinson's by making exercise more accessible and socially engaging.

What evidence suggests that this trial's in-home cycling program could be effective for Parkinson's disease?

This trial will evaluate the effectiveness of in-home cycling for people with Parkinson's disease. Research has shown that cycling at home can help manage symptoms. Participants in the Social Cycling Group will receive an exercise bike delivered to their home and engage in cycling sessions with social interaction. Studies have found that a home cycling program can slow movement problems caused by the disease. Specifically, people who cycled regularly experienced fewer movement issues over time compared to those who didn't cycle. Many participants also noticed quick improvements in symptoms like shaking and slow movement after intense cycling sessions. This suggests that regular cycling at home could effectively manage Parkinson's symptoms. ^{1 3 4 6 7}

Who Is on the Research Team?

Kristen A Pickett, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06616948

In-home Cycling for Individuals With PD: Effectiveness 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8632855/

Effectiveness of a Long-Term, Home-Based Aerobic Exercise ... A remotely supervised home-based aerobic exercise programme is feasible for patients with Parkinson's disease: results of a small randomised feasibility trial.

3. movementdisorders.org movementdisorders.org/MDS/News/Newsroom/News-Releases_BIN/IC25-releases/Cycling-fast-to-slow-Parkinsons-High-rate-exercise-regimen-results-in-lower-rate-of-motor-symptom-progression.htm

Cycling fast to slow Parkinson's: High-rate exercise ... Those prescribed the cycling regimen demonstrated a significantly lower rate of motor symptom progression at 12 months than those receiving ...

4. withpower.com withpower.com/trial/in-home-cycling-for-parkinsons-disease-bbb0b

In-home Cycling for Parkinson's Disease · Info for Participants Most participants experienced immediate improvements in tremor and bradykinesia after the AAC session, suggesting that high-intensity cycling could be an ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1474442219302856

Effectiveness of home-based and remotely supervised ... Aerobic exercise can be done at home by patients with Parkinson's disease with mild disease severity and it attenuates off-state motor signs.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04300023

In-home Cycling for Individuals With PD: Feasibility 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8463550/

Parkinson's disease patients benefit from bicycling Furthermore, our findings suggest that bicycling improves the overall quality-of-life of PD patients. Subject terms: Parkinson's disease, ...