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Effect of Physical Rehabilitation in Patients With Parkinson's Disease

Sponsor
Faculty of Medicine, Sousse (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06021834
Collaborator
(none)
40
Enrollment
2
Arms
1.2
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: rehabilitation
 N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Other
Official Title:
Effect of Physical Rehabilitation on Cardiorespiratory Parameters, Postural Balance and Sociopsychological and Cognitive Variables in Patients With Parkinson's Disease
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Oct 8, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control group

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Cardiorespiratory Parameters [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).

  2. Postural Balance [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

  3. Depression [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 .

  4. Cognitive Function [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) .

Secondary Outcome Measures

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

    handgrip test, Functional Reach Test, Five time to sit and stand test

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Faculty of Medicine, Sousse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ghazoua Nafti, Principal Investigator Ghazoua NAFTI, Faculty of Medicine, Sousse
ClinicalTrials.gov Identifier:
NCT06021834
Other Study ID Numbers:
  • Faculté de Médecine de Sousse
First Posted:
Sep 1, 2023
Last Update Posted:
Sep 1, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ghazoua Nafti, Principal Investigator Ghazoua NAFTI, Faculty of Medicine, Sousse
"Parkinson Disease"
"cognitive function"
"postural balance"
"physical rehabilitation"
Additional relevant MeSH terms:
Parkinson Disease

Study Results

No Results Posted as of Sep 1, 2023