NCT02476266

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

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

June 16, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

June 16, 2015

Last Update Submit

March 16, 2020

Conditions

Keywords

resistance trainingstrength trainingbalancemuscle strength

Outcome Measures

Primary Outcomes (3)

  • 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.

    Change in muscle activity, compensatory postural responses from baseline to 12 weeks.

  • Lean-and-Release Perturbation Technique.

    Change in muscle activity, compensatory postural responses from 12 weeks to three month wash out

  • Lean-and-Release Perturbation Technique.

    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)

    Change in motor severity from baseline to 12 weeks

  • Unified Parkinson's Disease Rating Scale Motor Subsection (UPDRS III)

    Change in motor severity from 12 weeks to three month wash out

  • Unified Parkinson's Disease Rating Scale Motor Subsection (UPDRS III)

    Change in motor severity from 12 weeks to six month wash out

  • Gait Measurement

    Changes in gait measures from baseline to 12 weeks

  • Gait Measurement

    Changes in gait measures from 12 weeks to three month wash out

  • +13 more secondary outcomes

Other Outcomes (4)

  • Parkinson's disease Quality of Life Questionnaire (PDQ-39)

    Change in score from baseline to 12 weeks

  • CHAMPS Questionnaire

    Changes in score from baseline to 12 weeks

  • CHAMPS Questionnaire

    Changes in score from 12 weeks three month wash out

  • +1 more other outcomes

Study Arms (3)

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.

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

Other: Resistance Training

Interventions

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.

Power TrainingStrength Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • a neurological disease other than PD
  • peripheral neuropathy
  • physical impairments that would prevent participation in the muscular strength testing
  • uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunlife Financial Movement Disorders Research and Rehabilitation Centre- Wilfrid Laurier University

Waterloo, Ontario, N2L 3C5, Canada

Location

Related Publications (6)

  • 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.

    PMID: 8265729BACKGROUND
  • Stolze 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.

    PMID: 15390043BACKGROUND
  • Wielinski 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.

    PMID: 15580552BACKGROUND
  • Newton 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.

    PMID: 9134365BACKGROUND
  • 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.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Brittany Intzandt, BSc

    Wilfrid Laurier University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

June 16, 2015

First Posted

June 19, 2015

Study Start

August 1, 2015

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations