Effect of Physical Rehabilitation in Patients With Parkinson's Disease

NCT06021834 | Unknown DMC

• 1 other identifier: Faculté de Médecine de Sousse
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective study. The aim of this study is to investigate the effect of exercise retraining on cardiorespiratory parameters, postural balance, sociopsychological variables, and cognitive function in subjects with Parkinson's disease. There will be two measurement sessions, one pre-intervention and one post-intervention (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and assessing cognitive function).

Conditions

Parkinson Disease

Keywords

"Parkinson Disease"; "cognitive function"; "postural balance"; "physical rehabilitation"

Outcome Measures

Primary Outcomes (4)

• Cardiorespiratory Parameters

  Cardiorespiratory Parameters will be assessed using the six-minute walk test (6MWT).

  There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)

• Postural Balance

  Postural balance will be assessed using the Timed Up and Go test (TUG) and stabilometry platform

  There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)

• Depression

  The depression variable will be assessed through Beck Depression Inventory-II .

  There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)

• Cognitive Function

  Cognitive function will be evaluated using the Montreal Cognitive Assessment score (MoCA) .

  There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)

Secondary Outcomes (1)

• Strength

  There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)

Study Arms (2)

control group

ACTIVE COMPARATOR

The control group will be invited to attend the program three times per week and will engage in an endurance training program

Other: rehabilitation

experimental group

EXPERIMENTAL

the experimental group will be invited to attend the program three times per week and will participate in a combined endurance training and cognitive training program.

Other: rehabilitation

Interventions

rehabilitation OTHER

The subjects will be invited to attend the program three times per week.

control group; experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Parkinson's disease according to the Movement Disorder Society (MDS) 2015 criteria.
• Mild to moderate stage according to the Hoehn and Yahr scale.
• No hearing or visual impairments that could hinder the integration and implementation of the rehabilitation protocol.
• Has the ability to communicate and walk.
• Patient has been stable on treatment for 3 months.

You may not qualify if:

• A contraindication to engaging in cardiovascular physical activity
• A Montreal Cognitive Assessment score (MoCA ) of less than 24.
• A current psychiatric disorder that could make it difficult or dangerous to adhere to the research protocol.
• Musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program.
• Treatment with sedative medications

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Ghazoua NAFTI

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: September 1, 2023
• Study Start: September 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 8, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08