Comparing the Effects of Instability Resistance Training Versus Aerobic Training on Cognitive and Motor Improvements Found in Parkinson's Disease Participants

Parkinson Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03711955
• Other study ID #: Sunlife1
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: September 2019
• Source: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
• Contact: Alisha Mistry
• Phone: 4164002909
• Email: mist4750[@]mylaurier.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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)

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:

1. Timed Up and Go test: mobility test measuring participants static and dynamic balance on gait mat (Protokinetic gait mat)

2. 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

3. Grip Strength test: measure overall strength

4. Unified Parkinson's Disease Rating Scale (UPDRS): assess various motor, cognitive, emotional and activities of daily living components of Parkinson's disease

5. 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

6. 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)

7. 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.

8. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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)

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Exercise
• Parkinson Disease

Intervention

Other:
• Exercise
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.

Locations

Country	Name	City	State
Canada	Movement Disorder Research and Rehabilitation Centre	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	executive function (memory, language and concentration)	memory, language and concentration will be measured using Montreal Cognitive Assessment test	change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
Primary	executive function (selective attention, cognitive flexibility)	selective attention, cognitive flexibility will be measured using the Delis-Kaplan Executive Function System test	change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
Primary	executive function (visual attention and task switching)	visual attention and task switching ability will be measured using the Trail Making Test	change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
Primary	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)	change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
Primary	gait variability	gait variability will be measured using the the Protokinetic Gait-walk test	change from baseline gait functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
Primary	muscular strength	muscular strength will be measured using the grip strength test (jamar dynamometer tool)	change from baseline muscular strength tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
Primary	gait (static and dynamic balance)	static and dynamic balance will be measured using Timed Up and Go Test	change from baseline gait functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
Primary	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)	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)

External Links

•   balance and fear of falling in subjects with Parkinson's disease is improved after exercises with motor complexities
•   resistance training with instability for patients with Parkinson's disease
•   symptom and gait changes after sensory attention focused exercise vs aerobic training in Parkinson's disease
•   synergic trail