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Clinical Trials/NCT06021834
NCT06021834
Not Yet Recruiting
N/A

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

Faculty of Medicine, Sousse0 sites40 target enrollmentSeptember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Faculty of Medicine, Sousse
Enrollment
40
Primary Endpoint
Cognitive Function
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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).

Detailed 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

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
October 8, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Faculty of Medicine, Sousse
Responsible Party
Principal Investigator
Principal Investigator

Ghazoua Nafti

Principal Investigator Ghazoua NAFTI

Faculty of Medicine, Sousse

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Cognitive Function

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

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

Cardiorespiratory Parameters

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

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

Postural Balance

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

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

Depression

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

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

Secondary Outcomes

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

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