Parkinson's DiseasePhase 2NCT01257945
Exercise for People With Parkinson's Disease
A Phase 2 study testing Aerobic Exercise, Flexibility and Function exercise program and Home exercise program in people with Parkinson's Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This randomized, controlled exercise intervention with three groups compares two exercise approaches to standard of care. Supervised interventions are administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Aerobic Exercise, Flexibility and Function exercise program and Home exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jul 2010
- Phase
- Phase 2
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson's Disease
- Hoehn \& Yahr stages 1-3.5
Who cannot join
- Cardiovascular contraindications to aerobic exercise
- Reliance on walker or wheelchair
- Psychiatric conditions
- DBS or other surgeries
- Any other conditions that would interfere with exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Exercise, Physical Function, and Parkinson's Disease
This randomized, controlled exercise intervention with three groups compares two exercise approaches to standard of care. Supervised interventions are administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. Functional outcomes are measured at the completion of the supervised exercise (4 months) as well as 10 and 16 months.
Read the detailed description
This randomized, controlled exercise intervention study compares physical therapy interventions for people in early and mid-stages of Parkinson's disease. Two different approaches to exercise are compared to standard of care. The two exercise programs consist of supervised interventions, administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. The standard of care program consists of a home program in which participants exercise in a group setting once a month with an exercise trainer. Functional outcomes are measured at the completion of the supervised exercise at 4 months as well as 10 and 16 months. This study is the first long term exercise study for people with Parkinson's disease PD of which we are aware and is the most comprehensive examination of exercise for people with PD to date. Results of this study will provide definitive information regarding the best approach to exercise for people in early and mid stages of PD, both in terms of immediate 4 month and long term 16 month effects.
- Conditions
- Parkinson's Disease
- Being tested
- Aerobic Exercise, Flexibility and Function exercise program, Home exercise program
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Flexibility and Function exercise programBehavioural
Home exercise programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Flexibility & Function | Experimental | Subjects take part in an exercise program based on flexibility and function. Receives: Behavioral: Flexibility and Function exercise program |
| Aerobic Exercise | Experimental | Subjects will take part in an aerobic exercise program Receives: Behavioral: Aerobic Exercise |
| Home exercise | Other | Standard of care home exercise program Receives: Behavioral: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Reach
Measure of balance
Measured: baseline, 4, 10, 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startApr 2003
- Primary completionApr 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 University of Colorado, DenverThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Margaret Schenkman, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257945
- Sponsor's protocol ID
- 02-0750
- Other IDs
- R01HD043770
- Status last verified
- Oct 2012
- First submitted
- 7 Dec 2010
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Christiansen CL, Schenkman ML, McFann K, Wolfe P, Kohrt WM. Walking economy in people with Parkinson's disease. Mov Disord. 2009 Jul 30;24(10):1481-7. doi: 10.1002/mds.22621.
PubMed 19441128Schenkman M, Hall D, Kumar R, Kohrt WM. Endurance exercise training to improve economy of movement of people with Parkinson disease: three case reports. Phys Ther. 2008 Jan;88(1):63-76. doi: 10.2522/ptj.20060351. Epub 2007 Oct 16.
PubMed 17940108Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886Schenkman M, Hall DA, Baron AE, Schwartz RS, Mettler P, Kohrt WM. Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. Phys Ther. 2012 Nov;92(11):1395-410. doi: 10.2522/ptj.20110472. Epub 2012 Jul 19.
PubMed 22822237
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise, Physical Function, and Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01257945
- Acronym / sponsor ID
- 02-0750
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2003
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Dec 2010 (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.
This randomized, controlled exercise intervention with three groups compares two exercise approaches to standard of care. Supervised interventions are administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. Functional outcomes are measured at the completion of the supervised exercise (4 months) as well as 10 and 16 months.
Detailed description
This randomized, controlled exercise intervention study compares physical therapy interventions for people in early and mid-stages of Parkinson's disease. Two different approaches to exercise are compared to standard of care. The two exercise programs consist of supervised interventions, administered for four months, with emphasis on patients adopting exercise habits to continue to exercise for an additional 12 months. The standard of care program consists of a home program in which participants exercise in a group setting once a month with an exercise trainer. Functional outcomes are measured at the completion of the supervised exercise at 4 months as well as 10 and 16 months. This study is the first long term exercise study for people with Parkinson's disease PD of which we are aware and is the most comprehensive examination of exercise for people with PD to date. Results of this study will provide definitive information regarding the best approach to exercise for people in early and mid stages of PD, both in terms of immediate 4 month and long term 16 month effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flexibility & Function | Experimental | Behavioral: Flexibility and Function exercise programSubjects take part in an exercise program based on flexibility and function. |
| Aerobic Exercise | Experimental | Behavioral: Aerobic ExerciseSubjects will take part in an aerobic exercise program |
| Home exercise | Other | Behavioral: Home exercise programStandard of care home exercise program |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Parkinson's Disease
- Hoehn \& Yahr stages 1-3.5
Key exclusion criteria (5 listed)
- Cardiovascular contraindications to aerobic exercise
- Reliance on walker or wheelchair
- Psychiatric conditions
- DBS or other surgeries
- Any other conditions that would interfere with exercise
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 |
|---|---|---|
| Aerobic Exercise | Behavioural | Aerobic Exercise |
| Flexibility and Function exercise program | Behavioural | Flexibility & Function |
| Home exercise program | Behavioural | Home exercise |
Primary outcome
Functional Reach
Time frame: baseline, 4, 10, 16 months
Measure of balance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Background: PubMed 19441128Christiansen CL, Schenkman ML, McFann K, Wolfe P, Kohrt WM. Walking economy in people with Parkinson's disease. Mov Disord. 2009 Jul 30;24(10):1481-7. doi: 10.1002/mds.22621.
- Results publication: PubMed 17940108Schenkman M, Hall D, Kumar R, Kohrt WM. Endurance exercise training to improve economy of movement of people with Parkinson disease: three case reports. Phys Ther. 2008 Jan;88(1):63-76. doi: 10.2522/ptj.20060351. Epub 2007 Oct 16.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- Derived from this study: PubMed 22822237Schenkman M, Hall DA, Baron AE, Schwartz RS, Mettler P, Kohrt WM. Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. Phys Ther. 2012 Nov;92(11):1395-410. doi: 10.2522/ptj.20110472. Epub 2012 Jul 19.
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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.
Margaret Schenkman principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerobic Exercise, Flexibility and Function exercise program and Home exercise program in people with Parkinson's Disease, run by University of Colorado, Denver 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Oct 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Reach (time frame: baseline, 4, 10, 16 months). 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 NCT01257945, which also lists 5 linked publications.
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 2 Oct 2012.