Effect of Physical Rehabilitation in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effect of Physical Rehabilitation on Cardiorespiratory Parameters, Postural Balance and Sociopsychological and Cognitive Variables in Patients With Parkinson's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06021834
• Other study ID #: Faculté de Médecine de Sousse
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: October 8, 2023

Study information

• Verified date: August 2023
• Source: Faculty of Medicine, Sousse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

this is a 12-week prospective study with the theme that I wish to develop in this context entitled "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).

The recruited subjects will be randomly assigned to two groups: a control group and an experimental group. The subjects will be invited to attend the program three times per week.

The control group will engage in an endurance training program, while the experimental group will participate in a combined endurance training and cognitive training program

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 8, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• rehabilitation
The subjects will be invited to attend the program three times per week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine, Sousse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Strength	handgrip test, Functional Reach Test, Five time to sit and stand test	There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)