Parkinson DiseaseNCT03618901
Rock Steady Boxing vs. Sensory Attention Focused Exercise
A study testing Rock Steady Boxing and PD SAFEx in people with Parkinson Disease, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.
Trial summary
This study evaluates the effect on Rock Steady Boxing (RSB) and PD SAFEx on Parkinson's disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Rock Steady Boxing and PD SAFEx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2018to 30 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- must be able to understand verbal instructions in English
- diagnosed with idiopathic PD by a neurologist
Who cannot join
- if diagnosed with a neurological condition other than PD
- if participated in an exercise program at least 2-weeks prior to the start of the study
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Movement Disorders Research and Rehabilitation Centre
Waterloo, Ontario, N2L 3J4
Kishoree Sangarapillai, Msc, 5198840710 ext. 3924, sang3490@mylaurier.ca
Quincy Almeida, PhD, 5198840710 ext. 3924, qalmeida@wlu.ca
About this study
Official title: A Randomized Crossover Trial: The Effects of Rock Steady Boxing vs. Sensory Attention Focused Exercise on Disease Progression for Those With Parkinson's Disease.
This study evaluates the effect on Rock Steady Boxing (RSB) and PD SAFEx on Parkinson's disease.
Read the detailed description
Both interventions produce benefits to the PD population. PD SAFEx has been proven to improve the motor symptoms of PD. However, research still needs to be conducted on the PD specific benefits associated with RSB. As such it an RCT is necessary to compare the effects of both interventions.
- Conditions
- Parkinson Disease
- Being tested
- Rock Steady Boxing, PD SAFEx
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rock Steady BoxingOther
Boxing programs as offered by the Rock Steady Boxing institution,
PD SAFExOther
Progressive proprioception training.
| Study group | Role | What they receive |
|---|---|---|
| Rock Steady Boxing | Experimental | Non-contact boxing program. Receives: Other: Rock Steady Boxing |
| PD SAFEx | Active comparator | Sensory attention focused exercise. Receives: Other: PD SAFEx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor symptom improvements
Unified Parkinson Disease Rating Scale (UPDRS) conducted by a qualified movement disorders specialist. The maximum score is 108, the higher the score, the worse the symptoms.
Measured: change from baseline at 12 weeks
Secondary outcomes (8)
Quality of life assessments
Completion of Parkinson's Disease Questionnaire (PDQ-39). There are 8 sections: mobility (sub score 10), activities of daily living (sub score 6), emotional well-being (sub score 6), stigma (sub score 4), social support (sub score 3), cognition (sub score 4), communication (sub score 3) and bodily discomfort (sub score 3). The higher the score, the worse the symptoms.
Measured: change from baseline at 12 weeks
Balance1
Using the Biodex balance system. The postural stability test (PST) will be conducted. The results will be presented as actual score and standard deviation for both legs to determine an individuals ability to maintain balance. The lower the score the better.
Measured: change from baseline at 12 weeks
Gait1
For the timed-up-and-go test (TUG) participants will stand up, walk to the line on the floor, turn around and walk back to the chair and sit down.
Measured: change from baseline at 12 weeks
Strength
Will be assessed using the Jamar hand dynamometer.
Measured: change from baseline at 12 weeks
Cognitive Assessment 1
Scale of Outcomes of Parkinson Disease (SCOPA-COG), will be used to assess memory and visuospatial function. There are 5 sections: memory learning, attention, executive functions, visuo-spatial functions and memory. The total score that can be achieved is 43 (the higher the score the better).
Measured: change from baseline at 12 weeks
cognitive assessment 3
Completion of Montreal Cognitive Assessment (MoCA). There are a total 30 points, the higher the score the better (26 and above is normal).
Measured: change from baseline at 12 weeks
Balance 2
Activities-specific Balance Confidence Scale (ABC). The total score that can be achieved is 16, the higher the percent the more self-confidence.
Measured: change from baseline at 12 weeks
Cognitive assessment 2
Mini-Mental State Examination (MMSE). The total score than can be achieved is otal score 30 (the higher the score the better).
Measured: change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start30 Sep 2018
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Aug 2019 (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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The early start group: 12-weeks (intervention) followed by 12-weeks of no exercise. The delayed start group: 12-weeks (no exercise) followed by 12-weeks (intervention). This model will be used for both RSB and PD SAFEx.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kishoree, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618901
- Sponsor's protocol ID
- MDRC2
- Status last verified
- May 2019
- First submitted
- 18 Jul 2018
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Trial: The Effects of Rock Steady Boxing vs. Sensory Attention Focused Exercise on Disease Progression for Those With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT03618901
- Acronym / sponsor ID
- MDRC2
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation CentreUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 7 Aug 2018 (actual)
- 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 study evaluates the effect on Rock Steady Boxing (RSB) and PD SAFEx on Parkinson's disease.
Detailed description
Both interventions produce benefits to the PD population. PD SAFEx has been proven to improve the motor symptoms of PD. However, research still needs to be conducted on the PD specific benefits associated with RSB. As such it an RCT is necessary to compare the effects of both interventions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The early start group: 12-weeks (intervention) followed by 12-weeks of no exercise. The delayed start group: 12-weeks (no exercise) followed by 12-weeks (intervention). This model will be used for both RSB and PD SAFEx.
| Arm | Type | Receives |
|---|---|---|
| Rock Steady Boxing | Experimental | Other: Rock Steady BoxingNon-contact boxing program. |
| PD SAFEx | Active comparator | Other: PD SAFExSensory attention focused exercise. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- must be able to understand verbal instructions in English
- diagnosed with idiopathic PD by a neurologist
Key exclusion criteria (2 listed)
- if diagnosed with a neurological condition other than PD
- if participated in an exercise program at least 2-weeks prior to the start of the study
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 |
|---|---|---|
| Rock Steady BoxingBoxing programs as offered by the Rock Steady Boxing institution, | Other | Rock Steady Boxing |
| PD SAFExProgressive proprioception training. | Other | PD SAFEx |
Primary outcome
Motor symptom improvements
Time frame: change from baseline at 12 weeks
Unified Parkinson Disease Rating Scale (UPDRS) conducted by a qualified movement disorders specialist. The maximum score is 108, the higher the score, the worse the symptoms.
8 secondary outcomes
Quality of life assessments
Time frame: change from baseline at 12 weeks
Balance1
Time frame: change from baseline at 12 weeks
Gait1
Time frame: change from baseline at 12 weeks
Strength
Time frame: change from baseline at 12 weeks
Cognitive Assessment 1
Time frame: change from baseline at 12 weeks
cognitive assessment 3
Time frame: change from baseline at 12 weeks
Balance 2
Time frame: change from baseline at 12 weeks
Cognitive assessment 2
Time frame: change from baseline at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- 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: 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.
Movement Disorders Research and Rehabilitation Centre
Waterloo, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rock Steady Boxing and PD SAFEx in people with Parkinson Disease, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre 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 2 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 16 May 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor symptom improvements (time frame: change from baseline at 12 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 NCT03618901, 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 16 May 2019; AzTrials last refreshed its copy on 3 Nov 2026.