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Exercise Therapy for Parkinson's Disease

Q: Does this clinical trial permit participants who are over eighty-five years of age?

The basic requirement for participants of this trial is that they must be between the ages of 45 and 80. Alternatively, there are 27 medical studies specifically dedicated to those younger than 18 years old as well as 485 trials designed for patients above 65 years in age.

Q: Is there an opportunity for me to enroll in this experiment?

For eligibility, an individual must have been diagnosed with <a href="https://www.withpower.com/clinical-trials/parkinson&#x27;s-disease">Parkinson's disease</a> and be aged between 45 and 80 years old. This clinical research project is searching for 60 participants in total.

Q: How many individuals are participating in the ongoing research?

Yes, the information posted on clinicaltrials.gov confirms that this medical trial is enrolling patients at the moment. It was first shared on September 15th 2021 and has been updated most recently in April 4th 2022; 60 people need to partake between 2 different sites.

Q: What aim is this experiment attempting to accomplish?

The primary measure of this 12-week trial is subjective <a href="https://www.withpower.com/clinical-trials/sleep">sleep</a> quality. Secondary metrics include the Scale for Outcomes in [<a href="https://www.withpower.com/clinical-trials/parkinson">Parkinson</a>'s disease](https://www.withpower.com/clinical-trials/parkinson's-disease) Cognition (ranging from 0-43, with higher scores indicating better performance), the Scale for Outcomes in Parkinson's Disease Psychosocial (0-33; higher values reflect worse psychosocial functioning) and a visuomotor tracking task to assess accuracy while performing motor tasks with the dominant hand.

Q: Are individuals being accepted for this clinical trial at the present time?

Affirmative. The information on clinicaltrials.gov attests to the ongoing recruitment for this medical experiment, which was initially posted in September 2021 and most recently modified in April 2022. 60 people are being sought after from 2 trial locations.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Cognition

Fatigue

Motor function

+3 more

Other outcome measures

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

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

~3200

2019

Completed Phase 1

~280

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McGill UniversityLead Sponsor

395 Previous Clinical Trials

999,317 Total Patients Enrolled

Jewish Rehabilitation HospitalOTHER

5 Previous Clinical Trials

720 Total Patients Enrolled

Media Library

Cardiovascular Training Clinical Trial Eligibility Overview. Trial Name: NCT04558879 — N/A

Parkinson's Disease Research Study Groups: Cardiovascular training, Resistance training

Parkinson's Disease Clinical Trial 2023: Cardiovascular Training Highlights & Side Effects. Trial Name: NCT04558879 — N/A

Cardiovascular Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04558879 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial permit participants who are over eighty-five years of age?

"The basic requirement for participants of this trial is that they must be between the ages of 45 and 80. Alternatively, there are 27 medical studies specifically dedicated to those younger than 18 years old as well as 485 trials designed for patients above 65 years in age."

Answered by AI

Is there an opportunity for me to enroll in this experiment?

"For eligibility, an individual must have been diagnosed with Parkinson's disease and be aged between 45 and 80 years old. This clinical research project is searching for 60 participants in total."

Answered by AI

How many individuals are participating in the ongoing research?

"Yes, the information posted on clinicaltrials.gov confirms that this medical trial is enrolling patients at the moment. It was first shared on September 15th 2021 and has been updated most recently in April 4th 2022; 60 people need to partake between 2 different sites."

Answered by AI

What aim is this experiment attempting to accomplish?

"The primary measure of this 12-week trial is subjective sleep quality. Secondary metrics include the Scale for Outcomes in [Parkinson's disease](https://www.withpower.com/clinical-trials/parkinson's-disease) Cognition (ranging from 0-43, with higher scores indicating better performance), the Scale for Outcomes in Parkinson's Disease Psychosocial (0-33; higher values reflect worse psychosocial functioning) and a visuomotor tracking task to assess accuracy while performing motor tasks with the dominant hand."

Answered by AI

Are individuals being accepted for this clinical trial at the present time?

"Affirmative. The information on clinicaltrials.gov attests to the ongoing recruitment for this medical experiment, which was initially posted in September 2021 and most recently modified in April 2022. 60 people are being sought after from 2 trial locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exercise and Sleep in Parkinson's Disease

Marc Roig 2021. "Exercise and Sleep in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04558879.

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