Exercise and Sleep in Parkinson's Disease

NCT04558879 | Recruiting

• 1 other identifier: 35450
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the impact of two common exercise modalities, cardiovascular and resistance training, on sleep quality and architecture in persons with Parkinson's disease (PD), and whether these potential positive changes in sleep are associated with improvements in brain plasticity and different quality of life (QoL)-related aspects. Participants will perform either cardiovascular training (CT) or resistance training (RT) for 12 weeks, at least two times/week. The assessments will be performed at baseline and after training by an assessor blinded to the participants' group allocation.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Rehabilitation; Neurosciences; Sleep; Exercise; Cardiovascular training; Resistance training; Cognition; Motor function; Quality of life

Outcome Measures

Primary Outcomes (3)

• Sleep efficiency (SE)

  Actigraphy; SE = total sleep time/time spent in bed.

  12 weeks

• Subjective sleep quality

  Parkinson's Disease Sleep Scale version 2 (PDSS-2); Score range from 0-60; higher scores represent worse sleep quality.

  12 weeks

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

  Polysomnography combined with electroencephalogram

  12 weeks

Secondary Outcomes (6)

• Motor function

  12 weeks

• Cognition

  12 weeks

• Fatigue

  12 weeks

• Psychosocial functioning

  12 weeks

• Quality of life-related aspects in Parkinson's disease

  12 weeks

Other Outcomes (4)

• Intra-cortical facilitation

  12 weeks

• Short intra-cortical inhibition

  12 weeks

• Silent period

  12 weeks

Study Arms (2)

Cardiovascular training

EXPERIMENTAL

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.

Behavioral: CT

Resistance training

EXPERIMENTAL

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.

Behavioral: RT

Interventions

CT BEHAVIORAL

12 weeks of exercise Cardiovascular Training

Cardiovascular training

RT BEHAVIORAL

12 weeks of exercise Resistance Training

Resistance training

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with mild-moderate idiopathic Parkinson's Disease (Modified Hoehn \& Yahr Scale stages 1-3);
• On a stable dosage of medication during the previous month;
• Having poor sleep quality defined as a score \> 18 in the PDSS-2(scores above this cut-off value define clinically relevant sleep disorders);

You may not qualify if:

• Having atypical parkinsonism, dementia or any other neurological, psychiatric or cardiovascular comorbidity affecting the ability to perform exercise;
• Presenting severe untreated obstructive sleep apnea (OSA);
• Having a Montreal Cognitive Assessment (MoCA) score \<21
• Having a Beck Depression Inventory (BDI version 2) score \>4
• Having absolute contraindications to exercise and to undergo transcranial magnetic stimulation (TMS);
• Currently are or will be enrolled in a drug or exercise trial during the duration of the study;
• Having participated in a structured exercise program \> 2 times per week in the two months prior to the enrollment in the study

Sponsors & Collaborators

• McGill University: lead
• Jewish Rehabilitation Hospital: collaborator

Study Sites (1)

Jewish Rehabiliation Hospital

Laval, Quebec, H7V 1R2, 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.

  PMID: 38588457 DERIVED

• 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.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Central Study Contacts

Marc Roig, PhD

CONTACT

514-398-4400; marc.roigpull@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 22, 2020
• Study Start: September 15, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)