Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402871737840 Date of Approval: 15/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Therapeutic effect of simultaneous physical and cognitive training in subjects with mild to moderate Parkinson's disease.
Official scientific title Effects of moderate-intensity physical activity coupled with a cognitive task on mental performance and functional capacity in Parkinson's patients: Comparison between continuous exercise and interval exercise
Brief summary describing the background and objectives of the trial Parkinson's disease (PD) is a complex and progressive disease characterized by various motor and non-motor symptoms.Cardinal motor features include resting tremor, rigidity, bradykinesia, postural instability, and altered gait patterns, including gait blockage. In addition to these motor symptoms, cognitive dysfunction is one of the most common non-motor comorbidities in patients with Parkinson's disease. Physical and cognitive exercise as an auxiliary method has few side effects, is easy to do, and is economically beneficial. It has been proven to positively affect gait, posture control, and cognitive functions, including attention and executive functions, in patients with PD. This is the first prospective study to investigate the acute effect of early neurological rehabilitation in patients with early to moderate Parkinson's disease.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) non
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 20/01/2024
Actual trial start date 20/02/2024
Anticipated date of last follow up 25/01/2024
Actual Last follow-up date 31/01/2024
Anticipated target sample size (number of participants) 35
Actual target sample size (number of participants) 22
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group MIITCT only one session DT interventions lasted 30 minutes and were conducted by two physiotherapists during the ON-state medication. DT interventions were based on aerobic exercise and cognitive tasks (CT). While performing the cognitive activities, the participants had to walk on the treadmill at a moderate continuous intensity.Participants should perform six interval training al least. Exercise-related heart rate variations should range from 60% to 70% of their maximal heart rate and self-paced on 11-13 on Borg’s scale during the two minutes of moderate interval training. Maximal heart rate should differ between 40 % to 50% of their maximal heart rate and self-paced 9-11 during the three minutes low interval training. moderate intensity interval training and cognitive task 11 Active-Treatment of Control Group
Experimental Group MITCCT only one session 30 minutes DT interventions lasted 30 minutes and were conducted by two physiotherapists during the ON-state medication. DT interventions were based on aerobic exercise and cognitive tasks (CT). While performing the cognitive activities, the participants had to walk on the treadmill at a moderate continuous intensity. 11
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Have mild to moderate Parkinson's disease. • Be 50 or older. • Subjects not undergoing other types of physical or cognitive interventions • Illiterate subjects. • With a chronic pathology that could affect their capacity for effort or the evaluation of walking parameters, balance or cycling: recent and/or unstable respiratory, neurological or musculoskeletal, cardiovascular pathologies ( e.g. heart attack, arrhythmia, angina pectoris, hypertension), insulin-dependent diabetes, or alcoholism or presenting contraindications to taking melatonin. • Advanced stage of Parkinson's disease Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/05/2023 C.P.P. SUD
Ethics Committee Address
Street address City Postal code Country
road el ain km 0.5 Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome physical performance evaluated by 10 m of walking test,postural balance by single leg balance test,functional capacity measured by timed up and go,30 secondes sit to stand test and four square step test and cognitive performance evaluated by Montreal Cognitive Assessment (MoCA),symbol digit modalities SDMT,verbal fluency,stroop test. 5 minutes post-intervention
Secondary Outcome depression by Hospital Anxiety and Depression Scale. 5 minutes after the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
department of Neurology University Hospital Habib Bourguiba Road el Ain Km 0.5 Sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Neurology University Habib Bourguiba Road el Ain km 0.5 Sfax 3029 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Departement of Neurology University Habib Bourguiba road el Ain km 0.5 Sfax 3029 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Mouna Turki road el Ain klm 0.5 Sfax 3029 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maryem Ben yahia Meryambenyahia96@gmail.com +21629273751 road el Ain km 0.5
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia PhD Student at Higher Institute of Sport and Physical Education of Sfax
Role Name Email Phone Street address
Scientific Enquiries Omar Hammouda omar.hammouda@parisnanterre.fr +33782931995 Avenue of the Republic
City Postal code Country Position/Affiliation
Paris 92000 France Interdisciplinary Laboratory in Neurosciences Physiology and Psychology Physical Activity Health and Learning
Role Name Email Phone Street address
Scientific Enquiries Nouha Farhat nouhafarhat15@gmail.com +21658128254 road el ain km 0.5
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Department of Neurology University Habib Bourguiba
Role Name Email Phone Street address
Scientific Enquiries Sonda Jallouli sondajallouli58@gmail.com +21644188641 road el Ain km 0.5
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia Doctor at Higher Institute of Sport and Physical Education of Sfax
Role Name Email Phone Street address
Scientific Enquiries Ines Mezghani mezghani.ines916@gmail.com +21620774874 road el ain km0.5
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia biochemistry department CHU Habib Bourguiba
Role Name Email Phone Street address
Public Enquiries Maryem Ben Yahia Meryambenyahia96@gmail.com +21629273751 road gremda km 2.5
City Postal code Country Position/Affiliation
Sfax 3032 Tunisia PhD Student at Higher Institute of Sport and Physical Education of Sfax
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participants data collected during the trial and after deidentification will be shared Informed Consent Form Data will be made available following publication. Access to data can be granted anyone who wishes to access it.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information