NCT03711955

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 18, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

October 11, 2018

Last Update Submit

September 20, 2019

Conditions

Outcome Measures

Primary Outcomes (8)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (2)

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).

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.

Other: Exercise

Interventions

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.

Aerobic training group (AET)Instability training group (IRT)

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Movement Disorder Research and Rehabilitation Centre

Waterloo, Ontario, N2L 3J4, Canada

RECRUITING

Related Publications (2)

  • 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.

  • 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. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

Related Links

MeSH Terms

Conditions

Motor ActivityParkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alisha Mistry

    Movement Disorder Research and Rehabilitation Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qunicy Almeida

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Investigator will not engage in the 8 week training program occurring, a leading supervisor will lead every training session so that the primary investigator (myself) will be blinded to the participants and their performance throughout the 8 week training interventions. Participants from the opposite training groups will have separate training session times. In this way, no participant from the opposite training group will have contact with each other (ex. aerobic training group's session is at 12pm; instability resistance training group's session is at 4pm).
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the aerobic training group/intervention or the instability resistance training group/intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 19, 2018

Study Start

February 18, 2019

Primary Completion

October 1, 2020

Study Completion

October 31, 2020

Last Updated

September 23, 2019

Record last verified: 2019-09

Locations