Recruiting

Instability Resistance vs. Aerobic

Sponsor:

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Code:

NCT03711955

Conditions

Exercise

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

Brief 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)

Conditions

Exercise

Parkinson Disease

Study ID

NCT03711955

Start date

Feb 18, 2019

Status verified date

Sep, 2019

Completion date

Oct 31, 2020

Anticipated

Primary completion date

Oct 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Aerobic training group (AET)

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).

experimental: Instability training group (IRT)

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.

Interventions

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.

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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Alisha Mistry

4164002909mist4750@mylaurier.ca

Qunicy Almeida

qalmeida@wlu.ca

Locations

Movement Disorder Research and Rehabilitation Centre

Recruiting

Waterloo, Ontario, Canada, N2L 3J4

Contacts

Quincy Almeida

519.884.0710mdrc@wlu.ca

Alisha Mistry

4164002909mist4750@mylaurier.ca

Principal Investigator:

Alisha Mistry

More Information

Sponsor

Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Last update posted

Sep 23, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sun Life Financial Movement Disorders Research and Rehabilitation Centre on 2019-09-23.