ExerciseNCT03711955
Comparing the Effects of Instability Resistance Training Versus Aerobic Training on Cognitive and Motor Improvements Found in Parkinson's Disease Participants
A study testing Exercise in people with Exercise and Parkinson Disease, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.
Trial summary
This study will be looking at the effects that instability resistance training and aerobic training, individually, have on the improvement of various motor and cognitive impairments present in individuals with Parkinson' disease. There will be 25-30 participants in this study (all of whom have Parkinson's disease). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Exercise, Parkinson Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 18 Feb 2019to 31 Oct 2020
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease participants aged between 50 to 80 years old
- Has idiopathic Parkinson's disease
- On stable medication (dopaminergic medication)
- Hoehn and Yahr stage between 2 and 3
- Does not present other neurological disorder other than Parkinson's disease)
- Does not have significant arthritis, cardiovascular disease, and cognitive impairment by Mini-Mental State Examination (score <23)
Show all 9Show fewer
- Has normal or corrected vision in at one eye in order to carry out exercise)
- Able to comply to scheduled visits, treatments, and other trial procedures
- Must be in sufficient health to participate in study's training program as determined through the use of Physical Activity Readiness Questionnaire-Plus (PARQ+) screening tool, coupled with evaluation by a certified exercise physiologist/physician for clearance to participate in training program
Who cannot join
- has uncontrolled hypertension and/or diabetes
- Is currently participating in any form of physical activity/exercise program that involves AET or RT two or more times a week in the last six months
- presence of dementia which is determined by having a score of 13 or less on the MoCa test.
- has significant arthritis, cardiovascular disease, and cognitive impairment by Mini-Mental State Examination (score <23)
Trial locations and contacts
1 site in 1 country.
Qunicy Almeida contact
Canada1 site, 1 recruiting
- Recruiting
Movement Disorder Research and Rehabilitation Centre
Waterloo, Ontario, N2L 3J4
Quincy Almeida, 519.884.0710 ext. 3924, mdrc@wlu.ca
Alisha Mistry, 4164002909, mist4750@mylaurier.ca
About this study
Official title: The Improvement in Cognitive and Motor Function: An 8 Week Study Comparing the Effects of Instability Resistance Training Versus Aerobic Training on Cognitive and Motor Improvements Found in Parkinson's Disease Participants.
This study will be looking at the effects that instability resistance training and aerobic training, individually, have on the improvement of various motor and cognitive impairments present in individuals with Parkinson' disease.
There will be 25-30 participants in this study (all of whom have Parkinson's disease). Once passing the eligibility criteria, participants will complete as series of baseline/pre-tests and then be randomly assigned to either the aerobic training group or the instability training group, where they will participate in every training session that occurs in the next 8 consecutive weeks. There will be 3 training sessions a week occurring on non-consecutive days (ex. Monday, Wednesday, Friday) for both training groups (3 aerobic training sessions, 3 instability resistance training sessions). Once the 8 week training intervention has been completed, a series of post-tests will occur exactly once week after (same tests used as in the pre-tests)
Read the detailed description
Twenty-eight to thirty selected participants that fit the eligibility criteria will go through a series of baseline (pre-test) tests during screening session. It should be noted that all participants are to be assessed in their clinical "ON" state (fully medicated).Motor and cognitive tests are conducted to determine the baseline level of participants in the following domain of motor and cognitive functions:
- Timed Up and Go test: mobility test measuring participants static and dynamic balance on gait mat (Protokinetic gait mat)
- Protokinetic gait mat: measure gait velocity and spatial and temporal gait variability (stride length, stride time, double support time, and step width) a.Measured through three tests: i.dual-tasking walking (counting backwards from 15, naming countries) ii.walking at normal speed (3 trails) iii.fast walking
- Grip Strength test: measure overall strength
- Unified Parkinson's Disease Rating Scale (UPDRS): assess various motor, cognitive, emotional and activities of daily living components of Parkinson's disease
- Montreal Cognitive Assessment (MoCa) test: assess cognitive domains and look for Mild Cognitive Impairment (MCI) (attention and concentration, executive functions, memory, language) with scores ranging from 13-24
- Trail-Making Test: tests visual attention and task-switching Part A: includes number 1-25, must draw lines and connect numbers in ascending order Part B: includes both letters and numbers; must draw lines connecting number and letters in ascending order ( but must alternate between number and letters, ex. 1-A-2-B)
- Delis-Kaplan Executive Function System: executive function deficits, those being: measurement of selective attention and cognitive flexibility Trial 1: participant would say out loud the patches of colour Trial 2: participant would read words out loud printed in black ink Trial 3: participant has to say the ink colour, not the word Trial 4: participant has to say the ink colour, not the word UNLESS the word is in a box, then the participant has to say the word and not say the ink colour.
- Parkinson Disease Cognitive Rating Scale : comprehensive cognitive function scale (measuring frontal sub-cortical and posterior cortical tasks)
Intervention Once baseline tests are completed, participants will be randomly assigned into either the instability resistance training group or the aerobic training group (done through RANDOM.org database), with each group receiving equal number of participants. Participants will participate in an eight week training program that will begin within one week after the baseline tests are completed. This training program will run over the course of eight weeks, with scheduled training sessions occurring three times a week (Monday, Wednesday, Friday), and will be running for one hour for both AET and IRT training groups. In total, there will be a total of twenty-four training sessions for both AET and IRT groups.
Aerobic Training
Each AET sessions are to last one hour, with 40 minutes being allocated to the aerobic exercise training component, 10 minutes allocated to warm-ups, 5 minutes allocated to cool-downs, and one 5 minute rest period between the 20 minutes spent on each machine (ex. 20 minutes of cycling, 5 minute rest, 20 minutes seated row). The AET program consists of 20 minutes of cycling on the stationary bicycle and 20 minutes of seated row on the kinesis Techno-gym machine. This is to be preceded by 10 minutes of static stretching during warm up, and 5 minutes of post-exercise recovery (dynamic stretches). The exercise intensity on both modalities (rowing machine and recumbent bicycle) is to be maintained throughout sessions by using the following checklist: 1) maintaining 70% of maximum heart rate (HRmax) predicted by age (determined by the formula HRmax=208-(0.7× age), 2) maintaining a pace of 50rpm, and 3) maintain a score below 5 on the Borg rating 10-point scale. Additionally, the resistance are to be kept at a constant weight throughout the 20 minutes of cycling and seated row, and is to only be increased/decreased when 1) participants are below the 70% maximum heart rate (HRmax) and/or 2) participants have a score above 5 on the Bohr scale (in which resistance/weights will be decreased). Each session will be led by lab supervisors/coordinators along with trained volunteers. The supervisors and volunteers will demonstrate, guide, monitor and assists participants in the exercises if required.
Instability Resistance Training
Each IRT sessions are to last one hour, with time being allocated to a 10 minute warm up, consisting of static stretches, a 5 minute cool down, consisting of dynamic stretches, and a series of IRT exercises performed in a circuit setting over the duration of 40 minutes. Just as the AET sessions, IRT sessions will run for one hour, three times a week, for eight-weeks. Before the beginning of the first session, a baseline performance is to be completed for every participant, to determine their 1 repetition maximum (RM) on each exercise modality. Once the baseline tests are completed, participants will begin their exercise sessions. In the sessions, five resistance exercises will be performed (reverse lunge row, half squats, ankle plantar flexion, push-ups, and trunk rotations). All the exercises shown, except push-ups, will be performed on the Techno-gym Kinesis machine. A linear periodization will occur, in which the training load will progress from high-volume low-intensity to low-volume high-intensity loads over the duration of eight weeks to maximize training adaptations(number of sets increase and the number of repetitions decrease). Additionally, there will be a progressive increase in load/resistance by 1-2 lbs and the degree of instability of each exercise during the course of the eight week program. Unstable devices will be changed from the least unstable to the most unstable device throughout the program (balance pad, balance discs, dyna discs, Swiss ball, BOSU ball), but only when participants showed a considerable decrease in body sway/movement and force production increased when performing exercises (ability to balance body on device and maintain center of mass). Furthermore, these devices are placed between the base of support for each participant and the floor. If participants are not able to perform an exercise with higher loads/resistance due to the increase in instability of new unstable device, participants must maintain the same load used in previous session. Rest time will be allocated throughout each session (30sec-1min rests between each set). Each session will be monitored, guided and assisted by leading lab supervisor/coordinator along with trained volunteers. The supervisors and volunteers will demonstrate, guide, monitor and assists participants in the exercises if required.
- Conditions
- Exercise, Parkinson Disease
- Being tested
- Exercise
- Medical subject headings
- Motor Activity, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Two types of training exercises, AET and IRT, will be used as the interventions in this study. Participants will either be assigned to the AET group or the IRT group, where they will participate in the respective training intervention group for 8 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training group (AET) | Experimental | Each AET sessions are to last one hour, with 40 minutes being allocated to the aerobic exercise training component, 10 minutes allocated to warm-ups, 5 minutes allocated to cool-downs, and one 5 minute rest period between the 20 minutes spent on each machine (20 minutes of cycling, 5 minute rest, 20 minutes seated row). The AET program consists of 20 minutes of cycling on the stationary bicycle and 20 minutes of seated row on the kinesis Technogym machine. This is to be preceded by 10 minutes of static stretching during warm up, and 5 minutes of post-exercise recovery (dynamic stretches). Receives: Other: Exercise |
| Instability training group (IRT) | Experimental | Each IRT sessions are to last one hour, with time being allocated to a 10 minute warm up, consisting of static stretches, a 5 minute cool down, consisting of dynamic stretches, and a series of IRT exercises performed in a circuit setting over the duration of 40 minutes. In the sessions, five resistance exercises will be performed. A linear periodization will occur, in which the training load will progress from high-volume low-intensity to low-volume high-intensity loads over the duration of eight weeks to maximize training adaptations. Additionally, there will be a progressive increase in load/resistance by 1-2 lbs and the degree of instability of each exercise during the course of the eight week program. Unstable devices will be changed from the least unstable to the most unstable device throughout the program, but only when participants showed a considerable decrease in body sway/movement and force production increased when performing exercises. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
executive function (memory, language and concentration)
memory, language and concentration will be measured using Montreal Cognitive Assessment test
Measured: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
executive function (selective attention, cognitive flexibility)
selective attention, cognitive flexibility will be measured using the Delis-Kaplan Executive Function System test
Measured: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
executive function (visual attention and task switching)
visual attention and task switching ability will be measured using the Trail Making Test
Measured: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
executive function (attention, working memory and recall verbal memory)
sustained attention, working memory, and immediate and delayed free recall verbal memory is measured using the Parkinson's Disease Cognitive Rating Scale (score total out of 134-the perfect score. The closer to 134, the the better results)
Measured: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
gait variability
gait variability will be measured using the the Protokinetic Gait-walk test
Measured: change from baseline gait functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
muscular strength
muscular strength will be measured using the grip strength test (jamar dynamometer tool)
Measured: change from baseline muscular strength tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
gait (static and dynamic balance)
static and dynamic balance will be measured using Timed Up and Go Test
Measured: change from baseline gait functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
assessing comprehensive motor and non-motor symptoms
assess non-motor experiences of daily living, motor experiences of daily living, motor examination, and motor complications symptoms will be assessed through the Unified Parkinson's Disease Rating Scale (0-4 rating scale, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe)
Measured: change from baseline motor and non-motor functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start18 Feb 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion31 Oct 2020 (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 ExerciseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the aerobic training group/intervention or the instability resistance training group/intervention
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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, Alisha Mistry, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
- Investigators
- Alisha Mistry, Principal investigator, Movement Disorder Research and Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711955
- Sponsor's protocol ID
- Sunlife1
- Status last verified
- Sep 2019
- First submitted
- 11 Oct 2018
- Last updated
- 23 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improvement in Cognitive and Motor Function: An 8 Week Study Comparing the Effects of Instability Resistance Training Versus Aerobic Training on Cognitive and Motor Improvements Found in Parkinson's Disease Participants.
- ClinicalTrials.gov ID
- NCT03711955
- Acronym / sponsor ID
- Sunlife1
- Conditions
- Exercise, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation CentreUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 19 Oct 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 will be looking at the effects that instability resistance training and aerobic training, individually, have on the improvement of various motor and cognitive impairments present in individuals with Parkinson' disease.
There will be 25-30 participants in this study (all of whom have Parkinson's disease). Once passing the eligibility criteria, participants will complete as series of baseline/pre-tests and then be randomly assigned to either the aerobic training group or the instability training group, where they will participate in every training session that occurs in the next 8 consecutive weeks. There will be 3 training sessions a week occurring on non-consecutive days (ex. Monday, Wednesday, Friday) for both training groups (3 aerobic training sessions, 3 instability resistance training sessions). Once the 8 week training intervention has been completed, a series of post-tests will occur exactly once week after (same tests used as in the pre-tests)
Detailed description
Twenty-eight to thirty selected participants that fit the eligibility criteria will go through a series of baseline (pre-test) tests during screening session. It should be noted that all participants are to be assessed in their clinical "ON" state (fully medicated).Motor and cognitive tests are conducted to determine the baseline level of participants in the following domain of motor and cognitive functions:
- Timed Up and Go test: mobility test measuring participants static and dynamic balance on gait mat (Protokinetic gait mat)
- Protokinetic gait mat: measure gait velocity and spatial and temporal gait variability (stride length, stride time, double support time, and step width) a.Measured through three tests: i.dual-tasking walking (counting backwards from 15, naming countries) ii.walking at normal speed (3 trails) iii.fast walking
- Grip Strength test: measure overall strength
- Unified Parkinson's Disease Rating Scale (UPDRS): assess various motor, cognitive, emotional and activities of daily living components of Parkinson's disease
- Montreal Cognitive Assessment (MoCa) test: assess cognitive domains and look for Mild Cognitive Impairment (MCI) (attention and concentration, executive functions, memory, language) with scores ranging from 13-24
- Trail-Making Test: tests visual attention and task-switching Part A: includes number 1-25, must draw lines and connect numbers in ascending order Part B: includes both letters and numbers; must draw lines connecting number and letters in ascending order ( but must alternate between number and letters, ex. 1-A-2-B)
- Delis-Kaplan Executive Function System: executive function deficits, those being: measurement of selective attention and cognitive flexibility Trial 1: participant would say out loud the patches of colour Trial 2: participant would read words out loud printed in black ink Trial 3: participant has to say the ink colour, not the word Trial 4: participant has to say the ink colour, not the word UNLESS the word is in a box, then the participant has to say the word and not say the ink colour.
- Parkinson Disease Cognitive Rating Scale : comprehensive cognitive function scale (measuring frontal sub-cortical and posterior cortical tasks)
Intervention Once baseline tests are completed, participants will be randomly assigned into either the instability resistance training group or the aerobic training group (done through RANDOM.org database), with each group receiving equal number of participants. Participants will participate in an eight week training program that will begin within one week after the baseline tests are completed. This training program will run over the course of eight weeks, with scheduled training sessions occurring three times a week (Monday, Wednesday, Friday), and will be running for one hour for both AET and IRT training groups. In total, there will be a total of twenty-four training sessions for both AET and IRT groups.
Aerobic Training
Each AET sessions are to last one hour, with 40 minutes being allocated to the aerobic exercise training component, 10 minutes allocated to warm-ups, 5 minutes allocated to cool-downs, and one 5 minute rest period between the 20 minutes spent on each machine (ex. 20 minutes of cycling, 5 minute rest, 20 minutes seated row). The AET program consists of 20 minutes of cycling on the stationary bicycle and 20 minutes of seated row on the kinesis Techno-gym machine. This is to be preceded by 10 minutes of static stretching during warm up, and 5 minutes of post-exercise recovery (dynamic stretches). The exercise intensity on both modalities (rowing machine and recumbent bicycle) is to be maintained throughout sessions by using the following checklist: 1) maintaining 70% of maximum heart rate (HRmax) predicted by age (determined by the formula HRmax=208-(0.7× age), 2) maintaining a pace of 50rpm, and 3) maintain a score below 5 on the Borg rating 10-point scale. Additionally, the resistance are to be kept at a constant weight throughout the 20 minutes of cycling and seated row, and is to only be increased/decreased when 1) participants are below the 70% maximum heart rate (HRmax) and/or 2) participants have a score above 5 on the Bohr scale (in which resistance/weights will be decreased). Each session will be led by lab supervisors/coordinators along with trained volunteers. The supervisors and volunteers will demonstrate, guide, monitor and assists participants in the exercises if required.
Instability Resistance Training
Each IRT sessions are to last one hour, with time being allocated to a 10 minute warm up, consisting of static stretches, a 5 minute cool down, consisting of dynamic stretches, and a series of IRT exercises performed in a circuit setting over the duration of 40 minutes. Just as the AET sessions, IRT sessions will run for one hour, three times a week, for eight-weeks. Before the beginning of the first session, a baseline performance is to be completed for every participant, to determine their 1 repetition maximum (RM) on each exercise modality. Once the baseline tests are completed, participants will begin their exercise sessions. In the sessions, five resistance exercises will be performed (reverse lunge row, half squats, ankle plantar flexion, push-ups, and trunk rotations). All the exercises shown, except push-ups, will be performed on the Techno-gym Kinesis machine. A linear periodization will occur, in which the training load will progress from high-volume low-intensity to low-volume high-intensity loads over the duration of eight weeks to maximize training adaptations(number of sets increase and the number of repetitions decrease). Additionally, there will be a progressive increase in load/resistance by 1-2 lbs and the degree of instability of each exercise during the course of the eight week program. Unstable devices will be changed from the least unstable to the most unstable device throughout the program (balance pad, balance discs, dyna discs, Swiss ball, BOSU ball), but only when participants showed a considerable decrease in body sway/movement and force production increased when performing exercises (ability to balance body on device and maintain center of mass). Furthermore, these devices are placed between the base of support for each participant and the floor. If participants are not able to perform an exercise with higher loads/resistance due to the increase in instability of new unstable device, participants must maintain the same load used in previous session. Rest time will be allocated throughout each session (30sec-1min rests between each set). Each session will be monitored, guided and assisted by leading lab supervisor/coordinator along with trained volunteers. The supervisors and volunteers will demonstrate, guide, monitor and assists participants in the exercises if required.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the aerobic training group/intervention or the instability resistance training group/intervention
| Arm | Type | Receives |
|---|---|---|
| Aerobic training group (AET) | Experimental | Other: ExerciseEach AET sessions are to last one hour, with 40 minutes being allocated to the aerobic exercise training component, 10 minutes allocated to warm-ups, 5 minutes allocated to cool-downs, and one 5 minute rest period between the 20 minutes spent on each machine (20 minutes of cycling, 5 minute rest, 20 minutes seated row). The AET program consists of 20 minutes of cycling on the stationary bicycle and 20 minutes of seated row on the kinesis Technogym machine. This is to be preceded by 10 minutes of static stretching during warm up, and 5 minutes of post-exercise recovery (dynamic stretches). |
| Instability training group (IRT) | Experimental | Other: ExerciseEach IRT sessions are to last one hour, with time being allocated to a 10 minute warm up, consisting of static stretches, a 5 minute cool down, consisting of dynamic stretches, and a series of IRT exercises performed in a circuit setting over the duration of 40 minutes. In the sessions, five resistance exercises will be performed. A linear periodization will occur, in which the training load will progress from high-volume low-intensity to low-volume high-intensity loads over the duration of eight weeks to maximize training adaptations. Additionally, there will be a progressive increase in load/resistance by 1-2 lbs and the degree of instability of each exercise during the course of the eight week program. Unstable devices will be changed from the least unstable to the most unstable device throughout the program, but only when participants showed a considerable decrease in body sway/movement and force production increased when performing exercises. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Parkinson's disease participants aged between 50 to 80 years old
- Has idiopathic Parkinson's disease
- On stable medication (dopaminergic medication)
- Hoehn and Yahr stage between 2 and 3
- Does not present other neurological disorder other than Parkinson's disease)
Key exclusion criteria (4 listed)
- has uncontrolled hypertension and/or diabetes
- Is currently participating in any form of physical activity/exercise program that involves AET or RT two or more times a week in the last six months
- presence of dementia which is determined by having a score of 13 or less on the MoCa test.
- has significant arthritis, cardiovascular disease, and cognitive impairment by Mini-Mental State Examination (score <23)
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 |
|---|---|---|
| ExerciseTwo types of training exercises, AET and IRT, will be used as the interventions in this study. Participants will either be assigned to the AET group or the IRT group, where they will participate in the respective training intervention group for 8 consecutive weeks. | Other | Aerobic training group (AET), Instability training group (IRT) |
Primary outcome
executive function (memory, language and concentration)
Time frame: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
memory, language and concentration will be measured using Montreal Cognitive Assessment test
executive function (selective attention, cognitive flexibility)
Time frame: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
selective attention, cognitive flexibility will be measured using the Delis-Kaplan Executive Function System test
executive function (visual attention and task switching)
Time frame: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
visual attention and task switching ability will be measured using the Trail Making Test
executive function (attention, working memory and recall verbal memory)
Time frame: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
sustained attention, working memory, and immediate and delayed free recall verbal memory is measured using the Parkinson's Disease Cognitive Rating Scale (score total out of 134-the perfect score. The closer to 134, the the better results)
gait variability
Time frame: change from baseline gait functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
gait variability will be measured using the the Protokinetic Gait-walk test
muscular strength
Time frame: change from baseline muscular strength tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
muscular strength will be measured using the grip strength test (jamar dynamometer tool)
gait (static and dynamic balance)
Time frame: change from baseline gait functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
static and dynamic balance will be measured using Timed Up and Go Test
assessing comprehensive motor and non-motor symptoms
Time frame: change from baseline motor and non-motor functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
assess non-motor experiences of daily living, motor experiences of daily living, motor examination, and motor complications symptoms will be assessed through the Unified Parkinson's Disease Rating Scale (0-4 rating scale, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 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.
- synergic trailLink provided by the sponsor.
- balance and fear of falling in subjects with Parkinson's disease is improved after exercises with motor complexitiesLink provided by the sponsor.
- resistance training with instability for patients with Parkinson's diseaseLink provided by the sponsor.
- symptom and gait changes after sensory attention focused exercise vs aerobic training in Parkinson's diseaseLink provided by the sponsor.
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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.
Qunicy Almeida contact
Alisha Mistry principal investigator
Movement Disorder Research and Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Exercise and 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 9 inclusion and 4 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 23 Sep 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?
Contact Alisha Mistry (4164002909, mist4750@mylaurier.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
executive function (memory, language and concentration) (time frame: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)). The study lists 8 primary outcomes in all. 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 NCT03711955, 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 23 Sep 2019.