Parkinson DiseaseNCT06021834
Effect of Physical Rehabilitation in Patients With Parkinson's Disease
A study testing rehabilitation in people with Parkinson Disease, run by Faculty of Medicine, Sousse.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 8 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Effect of Physical Rehabilitation on Cardiorespiratory Parameters, Postural Balance and Sociopsychological and Cognitive Variables in Patients With Parkinson's Disease
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).
Read the 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
- Conditions
- Parkinson Disease
- Being tested
- rehabilitation
- Keywords
- "Parkinson Disease", "cognitive function", "postural balance", "physical rehabilitation"
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitationOther
The subjects will be invited to attend the program three times per week.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Parameters
Cardiorespiratory Parameters will be assessed using the six-minute walk test (6MWT).
Measured: 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
Measured: 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 .
Measured: 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) .
Measured: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
Secondary outcomes (1)
Strength
handgrip test, Functional Reach Test, Five time to sit and stand test
Measured: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion8 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghazoua Nafti, Faculty of Medicine, Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021834
- Sponsor's protocol ID
- Faculté de Médecine de Sousse
- Status last verified
- Aug 2023
- First submitted
- 30 May 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Rehabilitation on Cardiorespiratory Parameters, Postural Balance and Sociopsychological and Cognitive Variables in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06021834
- Acronym / sponsor ID
- Faculté de Médecine de Sousse
- Conditions
- Parkinson Disease
- Keywords
- "Parkinson Disease", "cognitive function", "postural balance", "physical rehabilitation"
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 8 Oct 2023 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: rehabilitationThe control group will be invited to attend the program three times per week and will engage in an endurance training program |
| experimental group | Experimental | Other: rehabilitationthe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rehabilitationThe subjects will be invited to attend the program three times per week. | Other | control group, experimental group |
Primary outcome
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 .
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) .
1 secondary outcome
Strength
Time frame: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation in people with Parkinson Disease, run by Faculty of Medicine, Sousse.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Parameters (time frame: There will be two measurement sessions, one pre-intervention and one post-intervention (After 12 week for each patient)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.