Parkinson's DiseaseNCT02175082
Cycling in Parkinson's Disease
A study testing Cycling at Forced rate and Cycling at self-selected rate in people with Parkinson's Disease, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of a forced exercise aerobic exercise program, utilizing a cycling activity, on specific gait parameters and balance in individuals with Parkinson's Disease (PD). Design: pilot, feasibility, randomized control, evaluator blinded. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Cycling at Forced rate and Cycling at self-selected rate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's Disease
- Hoehn and Yahr Stages II - III.
- Ages 30-80 years
- Medical Clearance
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- MOCA: (Montreal Cognition Scale) : rating of less than 24, indicative of cognitive dysfunction
- Changes in Parkinson's medications within the two weeks prior to starting the study
- Anticipated change in Parkinson Disease medications during the course of the study
- Uncontrolled orthostasis
- Symptomatic coronary artery disease
- Fracture of lower limb within 6 months prior to study onset or significant lower limb orthopedic diagnosis that would limit cycling
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- Other significant neurologic diagnoses including multiple sclerosis or vestibular disease
- Acute illness
- Physical therapy within the month prior to study entry
- Subjects already participating in a forced exercise or high intensity exercise program
- Any medical condition that the physician investigator determined would compromise safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago)
Chicago, Illinois, 60611
About this study
Official title: A Forced Cycling Exercise Program in Individuals With Parkinson's Disease: Can it Improve Gait Parameters?
The purpose of this study is to assess the effectiveness of a forced exercise aerobic exercise program, utilizing a cycling activity, on specific gait parameters and balance in individuals with Parkinson's Disease (PD). Design: pilot, feasibility, randomized control, evaluator blinded. Subjects: Twenty four patients with idiopathic PD Hoehn and Yahr (H\&Y) stage II or III. Intervention: Participants randomly assigned to one of two exercise groups, forced exercise or self selected exercise, on cycling machine three times a week for 8 weeks. Both groups to exercise at same aerobic intensity level to keep heart rate at 60-80% heart rate max. Outcomes: Gait parameters of step length, width, and variability as measured by the GAITRite; 6 Minute Walk Test; mini-BESTest (balance testing); exercise tolerance via Patient Reported Outcomes Measurement Information System (PROMIS) scale.
- Conditions
- Parkinson's Disease
- Being tested
- Cycling at Forced rate, Cycling at self-selected rate
- Keywords
- Parkinson Disease, Exercise, Rehabilitation, Physical Therapy, Cycling
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycling at Forced rateOther
Cycling at self-selected rateOther
| Study group | Role | What they receive |
|---|---|---|
| Forced exercise cycling | Active comparator | Cycling exercise at approximately 90 rpm Receives: Other: Cycling at Forced rate |
| Self-selected pace cycling | Active comparator | Cycling at self selected rate, with same aerobic level as forced cycling group Receives: Other: Cycling at self-selected rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
Distance walked in 6 minutes
Measured: 8 weeks
Secondary outcomes (5)
Stride length
Length of stride in meters as measured by the GAITrite
Measured: 8 weeks
Step Width
Width of step in meters as measured by the GAITrite
Measured: 8 weeks
Step variability
Standard deviation of step as measure in meters by the Gaitrite system
Measured: 8 weeks
10 meter walk test
Time in seconds for the subject to walk 10 meters
Measured: 8 weeks
miniBESTest (Balance Evaluation Systems Test)
Subject is scored as the 14 activities on this scale are performed, and a summary score is derived.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2019
- Study completionJun 2019
Why it stopped: Terminated prior to enrollment goals due to difficulty with recruiting subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects were randomized to a delay start or immediate start group and then for the cycling, the intervention was randomized to : forced pace (80-90 revolutions per minute with equals 15 miles per hour cycling rate or self-selected with both groups working at similar aerobic levels
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Memorial Hospital, Paul Ruby Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Christina Marciniak, Shirley Ryan AbilityLab
- Investigators
- Christina M Marciniak, MD, Principal investigator, Shirley Ryan AbilityLab/Northwestern University Chicago IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175082
- Sponsor's protocol ID
- STU00093757
- Status last verified
- Oct 2020
- First submitted
- 21 Jun 2014
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sung P, Rafferty M, Doyle L, Kliver E, Bines K, Traines J, Scarpa A, Marciniak C, Solanki S, Todd A. Technology-based Forced Paced Cycling in Parkinson's disease: Is it Feasible and Effective?Archives of PM&R October 2019Volume 100, Issue 10, Page e126
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Forced Cycling Exercise Program in Individuals With Parkinson's Disease: Can it Improve Gait Parameters?
- ClinicalTrials.gov ID
- NCT02175082
- Acronym / sponsor ID
- STU00093757
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson Disease, Exercise, Rehabilitation, Physical Therapy, Cycling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated prior to enrollment goals due to difficulty with recruiting subjects
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Northwestern Memorial Hospital, Paul Ruby Foundation for Parkinson's Research
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effectiveness of a forced exercise aerobic exercise program, utilizing a cycling activity, on specific gait parameters and balance in individuals with Parkinson's Disease (PD). Design: pilot, feasibility, randomized control, evaluator blinded. Subjects: Twenty four patients with idiopathic PD Hoehn and Yahr (H\&Y) stage II or III. Intervention: Participants randomly assigned to one of two exercise groups, forced exercise or self selected exercise, on cycling machine three times a week for 8 weeks. Both groups to exercise at same aerobic intensity level to keep heart rate at 60-80% heart rate max. Outcomes: Gait parameters of step length, width, and variability as measured by the GAITRite; 6 Minute Walk Test; mini-BESTest (balance testing); exercise tolerance via Patient Reported Outcomes Measurement Information System (PROMIS) scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects were randomized to a delay start or immediate start group and then for the cycling, the intervention was randomized to : forced pace (80-90 revolutions per minute with equals 15 miles per hour cycling rate or self-selected with both groups working at similar aerobic levels
| Arm | Type | Receives |
|---|---|---|
| Forced exercise cycling | Active comparator | Other: Cycling at Forced rateCycling exercise at approximately 90 rpm |
| Self-selected pace cycling | Active comparator | Other: Cycling at self-selected rateCycling at self selected rate, with same aerobic level as forced cycling group |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Idiopathic Parkinson's Disease
- Hoehn and Yahr Stages II - III.
- Ages 30-80 years
- Medical Clearance
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (11 listed)
- MOCA: (Montreal Cognition Scale) : rating of less than 24, indicative of cognitive dysfunction
- Changes in Parkinson's medications within the two weeks prior to starting the study
- Anticipated change in Parkinson Disease medications during the course of the study
- Uncontrolled orthostasis
- Symptomatic coronary artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycling at Forced rate | Other | Forced exercise cycling |
| Cycling at self-selected rate | Other | Self-selected pace cycling |
Primary outcome
6-minute walk test
Time frame: 8 weeks
Distance walked in 6 minutes
5 secondary outcomes
Stride length
Time frame: 8 weeks
Step Width
Time frame: 8 weeks
Step variability
Time frame: 8 weeks
10 meter walk test
Time frame: 8 weeks
miniBESTest (Balance Evaluation Systems Test)
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Terminated prior to enrollment goals due to difficulty with recruiting subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Results publicationSung P, Rafferty M, Doyle L, Kliver E, Bines K, Traines J, Scarpa A, Marciniak C, Solanki S, Todd A. Technology-based Forced Paced Cycling in Parkinson's disease: Is it Feasible and Effective?Archives of PM&R October 2019Volume 100, Issue 10, Page e126
- Meeting abstract publishedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina M Marciniak, MD principal investigator
Shirley Ryan AbilityLab/Northwestern University Chicago IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycling at Forced rate and Cycling at self-selected rate in people with Parkinson's Disease, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated prior to enrollment goals due to difficulty with recruiting subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02175082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.