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Exercise Therapy for Parkinson's Disease

N/A

Recruiting

Research Sponsored by McGill University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Persons with mild-moderate idiopathic Parkinson's Disease (Modified Hoehn & Yahr Scale stages 1-3)

Be older than 18 years old

Must not have

Having absolute contraindications to exercise and to undergo transcranial magnetic stimulation (TMS)

Having a Montreal Cognitive Assessment (MoCA) score <21

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of two types of exercise on sleep quality and brain plasticity in people with Parkinson's disease.

Who is the study for?

This trial is for people with mild to moderate Parkinson's Disease who have poor sleep quality but are on stable medication. They should not be in other drug/exercise trials, have severe untreated sleep apnea, dementia or conditions that prevent exercise. A score >18 on PDSS-2 and <21 on MoCA excludes them.

What is being tested?

The study tests how cardiovascular (CT) and resistance training (RT) affect sleep quality in Parkinson's patients over 12 weeks of training at least twice a week. It also looks at whether better sleep improves brain function and life quality.

What are the potential side effects?

While the trial does not list specific side effects, general risks may include muscle soreness, fatigue from exercise, potential worsening of Parkinson’s symptoms temporarily after intense activity, and discomfort from assessments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Parkinson's Disease is in the early to middle stages.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot exercise or have TMS due to health risks.

Select...

My cognitive test score is below 21.

Select...

I have severe sleep apnea that hasn't been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective sleep measurements, including duration and percentage of sleep stages, total sleep time (TLT), wake after sleep onset (WASO), sleep latency (SL).

Sleep efficiency (SE)

Subjective sleep quality

Secondary study objectives

Cognition

Fatigue

Motor function

+3 more

Other study objectives

Cardiorespiratory fitness

Intra-cortical facilitation

Short intra-cortical inhibition

+1 more

Side effects data

From 2009 Phase 3 trial • 226 Patients • NCT00606632

19%

Nausea

12%

Constipation

12%

Procedural pain

12%

Fatigue

11%

Abdominal pain

11%

Headache

Diarrhoea

Incision site pain

Insomnia

Back pain

Vomitting

Dizziness

Anxiety

Dysgeusia

Pain

Haematuria

Haematoma

Pleural effusion

Dyspnoea

Pulmonary embolism

Urinary anastomotic leak

100%

80%

60%

40%

20%

Study treatment Arm

PET/CT Versus CT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Resistance trainingExperimental Treatment1 Intervention

Resistance training (RT) intensity will be estimated using the percentage of one-maximal repetition (1-RM) defined as the maximal weight liftable for ten maximal repetitions with proper form. The program will include five exercises (leg press, lat machine, leg extension, leg curl, bench press) and will start at high-volume low-intensity. RT will follow a periodization to reach high-intensity low-volume at the end of the intervention (week 12). The training sessions will start with five-minute of warm-up performed on a recumbent stepper and will end with five-minute of stretching (cool-down). RT's sessions will approximately last 45 minutes and will be interspersed with at least 48 hours of recovery.

Group II: Cardiovascular trainingExperimental Treatment1 Intervention

Cardiovascular training (CT) will be performed on a recumbent stepper. CT will start at low intensity, and through a linear progression will reach vigorous intensity; then, this intensity will be maintained until the end of the intervention. Each session will include five minutes of warm-up and cool-down performed at the beginning and the end of the training, respectively. Furthermore, five minutes of stretching will be performed after the cool down. CT's sessions will approximately last 45 minutes and will be interspersed with at least 48 hours of recovery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

2017

Completed Phase 3

~3270

2019

Completed Phase 1

~280

0 / 4Eligibility criteria met