Parkinson DiseaseNCT02615548
Exercise for Adults With Parkinson Disease
A study testing community-based exercise class and self-directed physical activity in people with Parkinson Disease, run by University of British Columbia at 1 site in Canada.
Trial summary
Physical activity is a key intervention used to reduce the healthcare costs and the negative consequences of Parkinson Disease (PD) by improving walking and balance and reducing the number of falls. However, not all exercise classes provide the same results for people with PD. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- community-based exercise class and self-directed physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Dec 2017
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic PD
- Hoehn \& Yahr stages 1 to 3 (17).These stages define early to mid-stage of PD.
- Adult men and/or women, age 45-80
- Willing and able to participate in 60-minute of physical activity, 3/week for 12-weeks, then 2/week for 36 weeks
Who cannot join
- History of any neurological, cardiovascular, or orthopedic condition that can limit their ability to participate
- Individuals who self-report engaging in more than 120 minutes of vigorous physical activity per week at baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effect of Specific, Long- Term, Community-based Exercises on Walking, Balance, and Quality of Life in Adults With Parkinson Disease.
Physical activity is a key intervention used to reduce the healthcare costs and the negative consequences of Parkinson Disease (PD) by improving walking and balance and reducing the number of falls. However, not all exercise classes provide the same results for people with PD. Specific exercises designed to target the features of PD have shown greater outcomes than generic physical activity. The exercise principles include high-intensity (size and speed) movement, task repetition, rhythmical rocking, mental imagery, cognitive strategies, treadmill walking, and making use of internal and external cues. Collectively these PD-specific exercises can be designed to be run in exercise groups. Structured exercise groups also include social interaction that is known to improve depression and apathy, both of which are features common in people with PD.
This study will compare the effect of specific, long-term community-based exercise class on balance, walking, quality of life, and mood compare to self-directed exercise.
Investigators anticipate that participants from the community-based, long-term intervention will show better improvements in balance and walking compare to participants that are self-directing their activities.
Read the detailed description
This is a mixed-method, randomized design study. Participants will be assessed using qualitative and quantitative measures before and after a nine-month intervention.Outcome measures for motor function will be described using Paired t-tests for continuous variables and McNemar's Test for categorical variables. Participants will be recruited from the LGH NROP program, North Shore physicians, and the Pacific Parkinson's Research Centre Movement Disorders Clinic, UBC. Potential participants will be approached by their treating physicians during their clinical visits. People who are interested in participating in the study will be invited to contact the NROP Registered Nurse (RN) to discuss study participation and review the inclusion and exclusion criteria. The study will recruit fifteen participants for the intensive community-based exercise group and fifteen for the self-directed exercise group.The sample size calculation was performed using G*power 3.1.9.2.Once participants provide a signed informed consent they will be randomly assigned to one of the groups by picking a number from 00 to 30 out of an envelope.
The class will consist of evidence-based exercises such as: sustained, high effort exercises, resistance exercises, and endurance training. The other participants will continue on their own. All participants will be asked to fill out a physical activity diary regarding the frequency, duration, and intensity of the activities during the nine months trial.
- Conditions
- Parkinson Disease
- Being tested
- community-based exercise class, self-directed physical activity
- Keywords
- exercises
- 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.
community-based exercise classOther
This intervention will be held in a community centre, twice per week, for 36 weeks.The participants will have an educational session regarding importance of regular exercise.The class will consist of evidence-based exercises such as: sustained, high effort exercises, resistance exercises, and endurance training.Two trainers with specific for Parkinson Disease training will lead the class.
self-directed physical activityOther
Participants from this group will have an educational session regarding importance of regular exercises for Parkinson Disease and will be asked to stay as active as possible.Both groups will be asked to fill out physical activity diary.
| Study group | Role | What they receive |
|---|---|---|
| Community exercise class | Experimental | Regular community exercise class is the intervention. It is an exercise class that incorporate PWR moves( UP,ROCK,STEP,TWIST) and cardiovascular training. Receives: Other: community-based exercise class |
| self-directed exercise activity | Active comparator | Self-directed exercise. Receives: Other: self-directed physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
. Functional Gait Assessment (FGA)
FGA is a 10-item test, assessing walking and balance.It is well validated as a predictor for falls for people with PD
Measured: Assess the change between baseline and post 9-month intervention.
Secondary outcomes (2)
6 minute walk test (6MWT)-
6 MWT assesses physical endurance. Participants will be asked to walk down a hallway at a comfortable speed for 6 min.
Measured: Assess the change between baseline and post 9-month intervention.
Semi-structured interview
To assess the attitude of participants toward the intervention
Measured: Assess the change between baseline and post 9-month intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health
- Responsible party
- Principal investigator, Diana Krasteva, University of British Columbia
- Investigators
- Diana Krasteva, Bachelor's, Principal investigator, Vancouver Coastal Health/ University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615548
- Sponsor's protocol ID
- H15-01772
- Status last verified
- Nov 2016
- First submitted
- 23 Nov 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ernst 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 36602886
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Specific, Long- Term, Community-based Exercises on Walking, Balance, and Quality of Life in Adults With Parkinson Disease.
- ClinicalTrials.gov ID
- NCT02615548
- Acronym / sponsor ID
- H15-01772
- Conditions
- Parkinson Disease
- Keywords
- exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health
- Study start
- Mar 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Nov 2015 (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.
Physical activity is a key intervention used to reduce the healthcare costs and the negative consequences of Parkinson Disease (PD) by improving walking and balance and reducing the number of falls. However, not all exercise classes provide the same results for people with PD. Specific exercises designed to target the features of PD have shown greater outcomes than generic physical activity. The exercise principles include high-intensity (size and speed) movement, task repetition, rhythmical rocking, mental imagery, cognitive strategies, treadmill walking, and making use of internal and external cues. Collectively these PD-specific exercises can be designed to be run in exercise groups. Structured exercise groups also include social interaction that is known to improve depression and apathy, both of which are features common in people with PD.
This study will compare the effect of specific, long-term community-based exercise class on balance, walking, quality of life, and mood compare to self-directed exercise.
Investigators anticipate that participants from the community-based, long-term intervention will show better improvements in balance and walking compare to participants that are self-directing their activities.
Detailed description
This is a mixed-method, randomized design study. Participants will be assessed using qualitative and quantitative measures before and after a nine-month intervention.Outcome measures for motor function will be described using Paired t-tests for continuous variables and McNemar's Test for categorical variables. Participants will be recruited from the LGH NROP program, North Shore physicians, and the Pacific Parkinson's Research Centre Movement Disorders Clinic, UBC. Potential participants will be approached by their treating physicians during their clinical visits. People who are interested in participating in the study will be invited to contact the NROP Registered Nurse (RN) to discuss study participation and review the inclusion and exclusion criteria. The study will recruit fifteen participants for the intensive community-based exercise group and fifteen for the self-directed exercise group.The sample size calculation was performed using G*power 3.1.9.2.Once participants provide a signed informed consent they will be randomly assigned to one of the groups by picking a number from 00 to 30 out of an envelope.
The class will consist of evidence-based exercises such as: sustained, high effort exercises, resistance exercises, and endurance training. The other participants will continue on their own. All participants will be asked to fill out a physical activity diary regarding the frequency, duration, and intensity of the activities during the nine months trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community exercise class | Experimental | Other: community-based exercise classRegular community exercise class is the intervention. It is an exercise class that incorporate PWR moves( UP,ROCK,STEP,TWIST) and cardiovascular training. |
| self-directed exercise activity | Active comparator | Other: self-directed physical activitySelf-directed exercise. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic PD
- Hoehn \& Yahr stages 1 to 3 (17).These stages define early to mid-stage of PD.
- Adult men and/or women, age 45-80
- Willing and able to participate in 60-minute of physical activity, 3/week for 12-weeks, then 2/week for 36 weeks
Key exclusion criteria (2 listed)
- History of any neurological, cardiovascular, or orthopedic condition that can limit their ability to participate
- Individuals who self-report engaging in more than 120 minutes of vigorous physical activity per week at baseline
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 |
|---|---|---|
| community-based exercise classThis intervention will be held in a community centre, twice per week, for 36 weeks.The participants will have an educational session regarding importance of regular exercise.The class will consist of evidence-based exercises such as: sustained, high effort exercises, resistance exercises, and endurance training.Two trainers with specific for Parkinson Disease training will lead the class. | Other | Community exercise class |
| self-directed physical activityParticipants from this group will have an educational session regarding importance of regular exercises for Parkinson Disease and will be asked to stay as active as possible.Both groups will be asked to fill out physical activity diary. | Other | self-directed exercise activity |
Primary outcome
. Functional Gait Assessment (FGA)
Time frame: Assess the change between baseline and post 9-month intervention.
FGA is a 10-item test, assessing walking and balance.It is well validated as a predictor for falls for people with PD
2 secondary outcomes
6 minute walk test (6MWT)-
Time frame: Assess the change between baseline and post 9-month intervention.
Semi-structured interview
Time frame: Assess the change between baseline and post 9-month intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Diana Krasteva, Bachelor's principal investigator
Vancouver Coastal Health/ University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing community-based exercise class and self-directed physical activity in people with Parkinson Disease, run by University of British Columbia at 1 site in Canada.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Nov 2016. 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 Canada. 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?
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?
. Functional Gait Assessment (FGA) (time frame: Assess the change between baseline and post 9-month intervention.). 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 NCT02615548, which also lists 2 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 22 Nov 2016.