Parkinson's DiseaseNCT02476266
Two Resistance Training Protocols to Reduce the Risk of Falls in Parkinson's Disease
A study testing Resistance Training in people with Parkinson's Disease and Accidental Falls, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre at 1 site in Canada.
Trial summary
Parkinson's disease (PD) is a chronic neurodegenerative disorder that is characterized by a multitude of symptoms. Impairments in balance, muscle deficits and increased risk of falls are commonly experienced in PD.The purpose of this study is to investigate the effects of two different resistance training programs on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Accidental Falls
- What is being tested?
- Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Sep 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with idiopathic PD by a Neurologist
- Able to stand two minutes, unassisted
- Able to understand English instructions
- Signed Physical Activity Readiness Medical Examination (PARmed-X) by physician
Who cannot join
- a neurological disease other than PD
- peripheral neuropathy
- physical impairments that would prevent participation in the muscular strength testing
- uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunlife Financial Movement Disorders Research and Rehabilitation Centre- Wilfrid Laurier University
Waterloo, Ontario, N2L 3C5
About this study
Official title: Power Training to Reduce Falls in Parkinson's Disease
Parkinson's disease (PD) is a chronic neurodegenerative disorder that is characterized by a multitude of symptoms. Impairments in balance, muscle deficits and increased risk of falls are commonly experienced in PD.The purpose of this study is to investigate the effects of two different resistance training programs on improving balance and muscular strength to thereby reduce the risk of falls in those with PD. This study will randomize individuals to one of two groups, a power training group, or a strength training group. Both interventional groups will participate in 12 weeks of resistance training, two times per week for an hour each exercise session.
Read the detailed description
Parkinson's disease (PD) is a neurodegenerative disorder that results in multiple hallmark symptoms, such as balance impairments, postural instability and muscular deficits. These symptoms, in combination with a deficient sensory-perceptual integration system, put individuals with PD at a higher risk of falls and fractures, compared to healthy older adults. With the expected rise in PD diagnosis, this will place an unprecedented burden on the Canadian healthcare system due to increased hospitalizations, surgeries, placement into long term care facilities, and rehabilitation. Improving symptom severity and delaying disease progression through rehabilitation strategies that improve balance and muscular deficits, can decrease falling risk in individuals with PD, potentially alleviating the projected burden on the healthcare system. For these reasons it is imperative to have the ability to directly measure the degree to which individuals with PD are at risk of experiencing falls through objective techniques.
Purpose: Therefore the purpose of this study is to examine the effects of two different forms of resistance training (RT) to improve the muscular deficits experienced, as well to improve the balance impairments experienced as it has been suggested that RT is able to do this not only in healthy older adults but in those with PD as well. The two RT programs that will be investigated are a conventional strength training (ST) program and a high velocity strength training, known as power training (PT) program.
Objective/Aim: The objective of this study is to identify if ST or PT is a more effective rehabilitation program to improving muscle strength and power, balance measures and reducing the risk of falls. Due to the nature of the PT intervention it is hypothesized that these individuals will experience the greatest improvements in outcome measures.
Methods/Design: This study will be a double blind randomized controlled trial. Participants will be blinded to group allocation except for the control group, however those in the interventional group will only be informed that they are participating in a RT program. The primary investigator will only collect measures that are considered to be objective at follow up time points. Pre-intervention measures will all be collected prior to randomization into group allocations. The assessor of disease severity will also be blinded to group allocation.
Participants will be randomized to one of three groups: i) a control group (to account for normal disease progression for the duration of the intervention); ii) ST group and iii) PT group.
The intervention will be a total of 12 weeks long, where participants will come in two days per week for an hour long session each day, for a total of 24 session.
Participants randomized to the ST group will complete three sets of 8-10 repetitions at 70% of their one repetition maximum (1-RM), as determined during their pre-test. Those randomized to the PT group will complete three sets of 12-15 repetitions at 40% of their 1-RM, as determined during their pre-test. Both programs involve individualized exercise prescriptions based on the results of their predicted 1-RM. This program will be designed by a Canadian Society for Exercise Physiology Certified Exercise Physiologist, who has the knowledge and ability to safely test and prescribe exercise to individuals with chronic conditions. Both programs will be progressive in nature, in that as each individual is able to complete the last set, for two consecutive training sessions at the higher end of the range of repetitions (i.e. for the ST group 10 or more repetitions), the next session their weight will be increased by 5%. Upon completion participants will complete all outcome measures again. These measures will be completed during a wash out period at 3 months and 6 months post intervention to investigate the potential long term effects of these rehabilitation programs, and if either is more advantageous in the long term.
- Conditions
- Parkinson's Disease, Accidental Falls
- Being tested
- Resistance Training
- Keywords
- resistance training, strength training, balance, muscle strength
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
Resistance training has been shown to improve balance and muscle weakness in those with PD as well as reducing the number of falls experienced, albeit not significantly. However to date no study has investigated forms of resistance training in the same study. To disentangle which form of resistance training might be more effective at reducing the risk of falls, improving balance and muscle strength, the proposed study will compare power training and conventional strength training.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants randomized to this group will come in for testing at pre-intervention, post-intervention, three month wash out and six month wash out. Participants will be asked to continue their activities of daily living. To account for any physical activity changes over the length of the study the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire will be administered to all individuals. A control group is necessary to compare to show normal disease progression over the length of the study as well as to demonstrate that improvements in outcome measures are due to the interventions and not practice effects. |
| Strength Training | Active comparator | Individuals randomized to this program will complete three sets of eight to ten repetitions at 70% of their predicted 1-RM for each of the exercises mentioned above. The speed of the movements in this program will be two to three seconds each for the concentric and eccentric components. When participants are able to complete ten repetitions in their third set for two consecutive days, weight will be increased for the following session by 5% of the current weight that they are at in accordance with Canadian Society for Exercise Physiology (CSEP) and American College of Sports Medicine (ACSM) guidelines. Participants will complete a total of 24 sessions over the course of 12 weeks, two times per week for an hour each session. Receives: Other: Resistance Training |
| Power Training | Experimental | Participants randomized to this program will complete three sets of 12 to 15 repetitions completed at 40% of predicted 1-RM for each exercises. The concentric part of the movement will be completed as fast as possible, whereas the eccentric component will be accomplished in two to three seconds. The load in this group is lower as it has been shown that by performing power training at lighter loads, the muscles are able to be activated, throughout the entire concentric component, while maintaining a consistent level of force. The progression will be determined through the same means as the conventional strength training group. Participants will complete a total of 24 sessions over 12 weeks, twice per week for an hour each session Receives: Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean-and-Release Perturbation Technique.
This measure will require participants to be in a forward static lean at a maximum lean angle of 20 degrees from the vertical. This measure will induce a fall like situation where participants will be required to respond to this "perturbation" as they would in a slip or a trip scenario in real life. Muscle activity will be collected through surface electromyography (sEMG) to measure muscular responses associated with the perturbation. Measurement of postural adjustments will be made on an electronic carpet. sEMG and postural adjustments will demonstrate participants' onset of muscular activation time, latency to stepping, movement speed, and stepping characteristics.
Measured: Change in muscle activity, compensatory postural responses from baseline to 12 weeks.
Lean-and-Release Perturbation Technique.
Measured: Change in muscle activity, compensatory postural responses from 12 weeks to three month wash out
Lean-and-Release Perturbation Technique.
Measured: Change in muscle activity, compensatory postural responses from 12 weeks to six month wash out
Secondary outcomes (18)
Unified Parkinson's Disease Rating Scale Motor Subsection (UPDRS III)
Motor symptom severity as assessed by a movement disorders specialist
Measured: Change in motor severity from baseline to 12 weeks
Unified Parkinson's Disease Rating Scale Motor Subsection (UPDRS III)
Measured: Change in motor severity from 12 weeks to three month wash out
Unified Parkinson's Disease Rating Scale Motor Subsection (UPDRS III)
Measured: Change in motor severity from 12 weeks to six month wash out
Gait Measurement
This measures spatiotemporal gait parameters of individuals. This will allow measurement of key predictors of fall risk in PD, including step length, step time, step width, velocity, double support time, double support time percentage, step time variability, and step length variability. Participants will also perform a secondary digit-monitoring task while walking in the same well-lit open room. Participants will walk while simultaneously listening to an audio track of random numbers greater than zero and less than 10. For each trial that included this task, the participants are assigned two specific digits and will be instructed to silently count (without the use of manual aid) the number of times those two digits were announced by the audio track, separately. At the end of the trial the participants will be asked to inform the tester of the number of times they heard each digit.
Measured: Changes in gait measures from baseline to 12 weeks
Gait Measurement
This measures spatiotemporal gait parameters of individuals. This will allow measurement of key predictors of fall risk in PD, including step length, step time, step width, velocity, double support time, double support time percentage, step time variability, and step length variability. Participants will also perform a secondary digit-monitoring task while walking in the same well-lit open room. Participants will walk while simultaneously listening to an audio track of random numbers greater than zero and less than 10. For each trial that included this task, the participants are assigned two specific digits and will be instructed to silently count (without the use of manual aid) the number of times those two digits were announced by the audio track, separately. At the end of the trial the participants will be asked to inform the tester of the number of times they heard each digit.
Measured: Changes in gait measures from 12 weeks to three month wash out
Gait Measurement
This measures spatiotemporal gait parameters of individuals. This will allow measurement of key predictors of fall risk in PD, including step length, step time, step width, velocity, double support time, double support time percentage, step time variability, and step length variability. Participants will also perform a secondary digit-monitoring task while walking in the same well-lit open room. Participants will walk while simultaneously listening to an audio track of random numbers greater than zero and less than 10. For each trial that included this task, the participants are assigned two specific digits and will be instructed to silently count (without the use of manual aid) the number of times those two digits were announced by the audio track, separately. At the end of the trial the participants will be asked to inform the tester of the number of times they heard each digit.
Measured: Changes in gait measures from 12 weeks to six month wash out
Balance Measurement
The Biodex Balance System™ SD will be used to assess balance outcomes. Specifically participants will be asked to complete two static balance tasks: i) eyes open- participants will be required to stand quietly for thirty seconds looking straight ahead and ii) eyes closed- participants will be required to stand quietly for thirty seconds with their eyes closed. Centre of pressure excursion will be measured in the anterior-posterior and medial-lateral directions to give an indication of participants overall postural stability.
Measured: Changes in postural stability measures from baseline to 12 weeks
Balance Measurement
The Biodex Balance System™ SD will be used to assess balance outcomes. Specifically participants will be asked to complete two static balance tasks: i) eyes open- participants will be required to stand quietly for thirty seconds looking straight ahead and ii) eyes closed- participants will be required to stand quietly for thirty seconds with their eyes closed. Centre of pressure excursion will be measured in the anterior-posterior and medial-lateral directions to give an indication of participants overall postural stability.
Measured: Changes in postural stability measures from 12 weeks to three month wash out
Balance Measurement
The Biodex Balance System™ SD will be used to assess balance outcomes. Specifically participants will be asked to complete two static balance tasks: i) eyes open- participants will be required to stand quietly for thirty seconds looking straight ahead and ii) eyes closed- participants will be required to stand quietly for thirty seconds with their eyes closed. Centre of pressure excursion will be measured in the anterior-posterior and medial-lateral directions to give an indication of participants overall postural stability.
Measured: Changes in postural stability measures from 12 weeks to six month wash out
Muscular Strength and Power Assessment
Technogym Selection Leg Press used to assess muscular strength and power. Participants will be completing a submaximal muscular strength protocol (multiple repetition maximum), which can be used to predict a one repetition maximum (1-RM).
Measured: Changes in muscle strength measures from baseline to 12 weeks
Muscular Strength and Power Assessment
Technogym Selection Leg Press used to assess muscular strength and power. Participants will be completing a submaximal muscular strength protocol (multiple repetition maximum), which can be used to predict a one repetition maximum (1-RM).
Measured: Changes in muscle strength measures from 12 weeks to three month wash out
Muscular Strength and Power Assessment
Technogym Selection Leg Press used to assess muscular strength and power. Participants will be completing a submaximal muscular strength protocol (multiple repetition maximum), which can be used to predict a one repetition maximum (1-RM).
Measured: Changes in muscle strength measures from 12 weeks to six month wash out
Timed Up and Go (TUG)
A timed up and go test (TUG test) will be administered as an assessment of function. Briefly, participants will be asked to begin the test by sitting in a chair, then to get up out of the chair without use of their hands and walk three metres then turn around and walk back to the chair and sit in it. Gait characteristics will be measured (step time, step length, step variability, velocity, time spent in double support. This test will occur three times.
Measured: Changes in time and gait measures from baseline to 12 weeks
Timed Up and Go (TUG)
A timed up and go test (TUG test) will be administered as an assessment of function. Briefly, participants will be asked to begin the test by sitting in a chair, then to get up out of the chair without use of their hands and walk three metres then turn around and walk back to the chair and sit in it. Gait characteristics will be measured (step time, step length, step variability, velocity, time spent in double support. This test will occur three times.
Measured: Changes in time and gait measures from 12 weeks to three month wash out
Timed Up and Go (TUG)
A timed up and go test (TUG test) will be administered as an assessment of function. Briefly, participants will be asked to begin the test by sitting in a chair, then to get up out of the chair without use of their hands and walk three metres then turn around and walk back to the chair and sit in it. Gait characteristics will be measured (step time, step length, step variability, velocity, time spent in double support. This test will occur three times.
Measured: Changes in time and gait measures from 12 weeks to six month wash out
Thirty Second Sit to Stand
A thirty second sit to stand test will also be used as it is a functional measure of lower limb muscle strength. Participants will begin the test by sitting in a chair that is placed against a wall for safety. They will then be asked to go from a sitting position to a standing position as many times as possible in a thirty second time frame.
Measured: Change in number of sit to stands completed from baseline to 12 weeks
Thirty Second Sit to Stand
A thirty second sit to stand test will also be used as it is a functional measure of lower limb muscle strength. Participants will begin the test by sitting in a chair that is placed against a wall for safety. They will then be asked to go from a sitting position to a standing position as many times as possible in a thirty second time frame.
Measured: Change in number of sit to stands completed from 12 weeks to three month wash out
Thirty Second Sit to Stand
A thirty second sit to stand test will also be used as it is a functional measure of lower limb muscle strength. Participants will begin the test by sitting in a chair that is placed against a wall for safety. They will then be asked to go from a sitting position to a standing position as many times as possible in a thirty second time frame.
Measured: Change in number of sit to stands completed from 12 weeks to six month wash out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson's 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brittany Intzandt, Sun Life Financial Movement Disorders Research and Rehabilitation Centre
- Investigators
- Brittany Intzandt, BSc, Study director, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476266
- Sponsor's protocol ID
- 3992
- Status last verified
- Mar 2020
- First submitted
- 16 Jun 2015
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Glendinning DS, Enoka RM. Motor unit behavior in Parkinson's disease. Phys Ther. 1994 Jan;74(1):61-70. doi: 10.1093/ptj/74.1.61.
PubMed 8265729Stolze H, Klebe S, Baecker C, Zechlin C, Friege L, Pohle S, Deuschl G. Prevalence of gait disorders in hospitalized neurological patients. Mov Disord. 2005 Jan;20(1):89-94. doi: 10.1002/mds.20266.
PubMed 15390043Wielinski CL, Erickson-Davis C, Wichmann R, Walde-Douglas M, Parashos SA. Falls and injuries resulting from falls among patients with Parkinson's disease and other parkinsonian syndromes. Mov Disord. 2005 Apr;20(4):410-415. doi: 10.1002/mds.20347.
PubMed 15580552Newton RU, Murphy AJ, Humphries BJ, Wilson GJ, Kraemer WJ, Hakkinen K. Influence of load and stretch shortening cycle on the kinematics, kinetics and muscle activation that occurs during explosive upper-body movements. Eur J Appl Physiol Occup Physiol. 1997;75(4):333-42. doi: 10.1007/s004210050169.
PubMed 9134365Ernst 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 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Power Training to Reduce Falls in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02476266
- Acronym / sponsor ID
- 3992
- Conditions
- Parkinson's Disease, Accidental Falls
- Keywords
- resistance training, strength training, balance, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation CentreUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Jun 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.
Parkinson's disease (PD) is a chronic neurodegenerative disorder that is characterized by a multitude of symptoms. Impairments in balance, muscle deficits and increased risk of falls are commonly experienced in PD.The purpose of this study is to investigate the effects of two different resistance training programs on improving balance and muscular strength to thereby reduce the risk of falls in those with PD. This study will randomize individuals to one of two groups, a power training group, or a strength training group. Both interventional groups will participate in 12 weeks of resistance training, two times per week for an hour each exercise session.
Detailed description
Parkinson's disease (PD) is a neurodegenerative disorder that results in multiple hallmark symptoms, such as balance impairments, postural instability and muscular deficits. These symptoms, in combination with a deficient sensory-perceptual integration system, put individuals with PD at a higher risk of falls and fractures, compared to healthy older adults. With the expected rise in PD diagnosis, this will place an unprecedented burden on the Canadian healthcare system due to increased hospitalizations, surgeries, placement into long term care facilities, and rehabilitation. Improving symptom severity and delaying disease progression through rehabilitation strategies that improve balance and muscular deficits, can decrease falling risk in individuals with PD, potentially alleviating the projected burden on the healthcare system. For these reasons it is imperative to have the ability to directly measure the degree to which individuals with PD are at risk of experiencing falls through objective techniques.
Purpose: Therefore the purpose of this study is to examine the effects of two different forms of resistance training (RT) to improve the muscular deficits experienced, as well to improve the balance impairments experienced as it has been suggested that RT is able to do this not only in healthy older adults but in those with PD as well. The two RT programs that will be investigated are a conventional strength training (ST) program and a high velocity strength training, known as power training (PT) program.
Objective/Aim: The objective of this study is to identify if ST or PT is a more effective rehabilitation program to improving muscle strength and power, balance measures and reducing the risk of falls. Due to the nature of the PT intervention it is hypothesized that these individuals will experience the greatest improvements in outcome measures.
Methods/Design: This study will be a double blind randomized controlled trial. Participants will be blinded to group allocation except for the control group, however those in the interventional group will only be informed that they are participating in a RT program. The primary investigator will only collect measures that are considered to be objective at follow up time points. Pre-intervention measures will all be collected prior to randomization into group allocations. The assessor of disease severity will also be blinded to group allocation.
Participants will be randomized to one of three groups: i) a control group (to account for normal disease progression for the duration of the intervention); ii) ST group and iii) PT group.
The intervention will be a total of 12 weeks long, where participants will come in two days per week for an hour long session each day, for a total of 24 session.
Participants randomized to the ST group will complete three sets of 8-10 repetitions at 70% of their one repetition maximum (1-RM), as determined during their pre-test. Those randomized to the PT group will complete three sets of 12-15 repetitions at 40% of their 1-RM, as determined during their pre-test. Both programs involve individualized exercise prescriptions based on the results of their predicted 1-RM. This program will be designed by a Canadian Society for Exercise Physiology Certified Exercise Physiologist, who has the knowledge and ability to safely test and prescribe exercise to individuals with chronic conditions. Both programs will be progressive in nature, in that as each individual is able to complete the last set, for two consecutive training sessions at the higher end of the range of repetitions (i.e. for the ST group 10 or more repetitions), the next session their weight will be increased by 5%. Upon completion participants will complete all outcome measures again. These measures will be completed during a wash out period at 3 months and 6 months post intervention to investigate the potential long term effects of these rehabilitation programs, and if either is more advantageous in the long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants randomized to this group will come in for testing at pre-intervention, post-intervention, three month wash out and six month wash out. Participants will be asked to continue their activities of daily living. To account for any physical activity changes over the length of the study the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire will be administered to all individuals. A control group is necessary to compare to show normal disease progression over the length of the study as well as to demonstrate that improvements in outcome measures are due to the interventions and not practice effects. |
| Strength Training | Active comparator | Other: Resistance TrainingIndividuals randomized to this program will complete three sets of eight to ten repetitions at 70% of their predicted 1-RM for each of the exercises mentioned above. The speed of the movements in this program will be two to three seconds each for the concentric and eccentric components. When participants are able to complete ten repetitions in their third set for two consecutive days, weight will be increased for the following session by 5% of the current weight that they are at in accordance with Canadian Society for Exercise Physiology (CSEP) and American College of Sports Medicine (ACSM) guidelines. Participants will complete a total of 24 sessions over the course of 12 weeks, two times per week for an hour each session. |
| Power Training | Experimental | Other: Resistance TrainingParticipants randomized to this program will complete three sets of 12 to 15 repetitions completed at 40% of predicted 1-RM for each exercises. The concentric part of the movement will be completed as fast as possible, whereas the eccentric component will be accomplished in two to three seconds. The load in this group is lower as it has been shown that by performing power training at lighter loads, the muscles are able to be activated, throughout the entire concentric component, while maintaining a consistent level of force. The progression will be determined through the same means as the conventional strength training group. Participants will complete a total of 24 sessions over 12 weeks, twice per week for an hour each session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with idiopathic PD by a Neurologist
- Able to stand two minutes, unassisted
- Able to understand English instructions
- Signed Physical Activity Readiness Medical Examination (PARmed-X) by physician
Key exclusion criteria (4 listed)
- a neurological disease other than PD
- peripheral neuropathy
- physical impairments that would prevent participation in the muscular strength testing
- uncontrolled hypertension
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 |
|---|---|---|
| Resistance TrainingResistance training has been shown to improve balance and muscle weakness in those with PD as well as reducing the number of falls experienced, albeit not significantly. However to date no study has investigated forms of resistance training in the same study. To disentangle which form of resistance training might be more effective at reducing the risk of falls, improving balance and muscle strength, the proposed study will compare power training and conventional strength training. | Other | Power Training, Strength Training |
Primary outcome
Lean-and-Release Perturbation Technique.
Time frame: Change in muscle activity, compensatory postural responses from baseline to 12 weeks.
This measure will require participants to be in a forward static lean at a maximum lean angle of 20 degrees from the vertical. This measure will induce a fall like situation where participants will be required to respond to this "perturbation" as they would in a slip or a trip scenario in real life. Muscle activity will be collected through surface electromyography (sEMG) to measure muscular responses associated with the perturbation. Measurement of postural adjustments will be made on an electronic carpet. sEMG and postural adjustments will demonstrate participants' onset of muscular activation time, latency to stepping, movement speed, and stepping characteristics.
Lean-and-Release Perturbation Technique.
Time frame: Change in muscle activity, compensatory postural responses from 12 weeks to three month wash out
Lean-and-Release Perturbation Technique.
Time frame: Change in muscle activity, compensatory postural responses from 12 weeks to six month wash out
18 secondary outcomes
Unified Parkinson's Disease Rating Scale Motor Subsection (UPDRS III)
Time frame: Change in motor severity from baseline to 12 weeks
Unified Parkinson's Disease Rating Scale Motor Subsection (UPDRS III)
Time frame: Change in motor severity from 12 weeks to three month wash out
Unified Parkinson's Disease Rating Scale Motor Subsection (UPDRS III)
Time frame: Change in motor severity from 12 weeks to six month wash out
Gait Measurement
Time frame: Changes in gait measures from baseline to 12 weeks
Gait Measurement
Time frame: Changes in gait measures from 12 weeks to three month wash out
Gait Measurement
Time frame: Changes in gait measures from 12 weeks to six month wash out
Balance Measurement
Time frame: Changes in postural stability measures from baseline to 12 weeks
Balance Measurement
Time frame: Changes in postural stability measures from 12 weeks to three month wash out
Balance Measurement
Time frame: Changes in postural stability measures from 12 weeks to six month wash out
Muscular Strength and Power Assessment
Time frame: Changes in muscle strength measures from baseline to 12 weeks
Muscular Strength and Power Assessment
Time frame: Changes in muscle strength measures from 12 weeks to three month wash out
Muscular Strength and Power Assessment
Time frame: Changes in muscle strength measures from 12 weeks to six month wash out
Timed Up and Go (TUG)
Time frame: Changes in time and gait measures from baseline to 12 weeks
Timed Up and Go (TUG)
Time frame: Changes in time and gait measures from 12 weeks to three month wash out
Timed Up and Go (TUG)
Time frame: Changes in time and gait measures from 12 weeks to six month wash out
Thirty Second Sit to Stand
Time frame: Change in number of sit to stands completed from baseline to 12 weeks
Thirty Second Sit to Stand
Time frame: Change in number of sit to stands completed from 12 weeks to three month wash out
Thirty Second Sit to Stand
Time frame: Change in number of sit to stands completed from 12 weeks to six month wash out
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 17 Mar 2020.
- Background: PubMed 8265729Glendinning DS, Enoka RM. Motor unit behavior in Parkinson's disease. Phys Ther. 1994 Jan;74(1):61-70. doi: 10.1093/ptj/74.1.61.
- Background: PubMed 15390043Stolze H, Klebe S, Baecker C, Zechlin C, Friege L, Pohle S, Deuschl G. Prevalence of gait disorders in hospitalized neurological patients. Mov Disord. 2005 Jan;20(1):89-94. doi: 10.1002/mds.20266.
- Background: PubMed 15580552Wielinski CL, Erickson-Davis C, Wichmann R, Walde-Douglas M, Parashos SA. Falls and injuries resulting from falls among patients with Parkinson's disease and other parkinsonian syndromes. Mov Disord. 2005 Apr;20(4):410-415. doi: 10.1002/mds.20347.
- Background: PubMed 9134365Newton RU, Murphy AJ, Humphries BJ, Wilson GJ, Kraemer WJ, Hakkinen K. Influence of load and stretch shortening cycle on the kinematics, kinetics and muscle activation that occurs during explosive upper-body movements. Eur J Appl Physiol Occup Physiol. 1997;75(4):333-42. doi: 10.1007/s004210050169.
- 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.
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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.
Brittany Intzandt, BSc study director
Wilfrid Laurier University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with Parkinson's Disease and Accidental Falls, 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 4 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: finished, as of the sponsor's last update on 17 Mar 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 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?
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?
Lean-and-Release Perturbation Technique. (time frame: Change in muscle activity, compensatory postural responses from baseline to 12 weeks.). The study lists 3 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 NCT02476266, which also lists 6 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 17 Mar 2020.