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.: PACTR202306897496740 Date of Approval: 27/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Physical Performance and Cognitive Functioning in Patients with Alzheimer's Disease. The implication of Music Therapy and/or Adapted Physical Activity: A Randomized Controlled Trial
Official scientific title Physical Performance and Cognitive Functioning in Patients with Alzheimer's Disease. The implication of Music Therapy and/or Adapted Physical Activity: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial ABSTRACT In recent years, there has been growing interest in exploring nonpharmacological therapies as a viable alternative or complement to pharmacological interventions for individuals with Alzheimer's disease (AD), aiming to address the multifaceted challenges associated with the condition and potentially provide preventive strategies. This randomized controlled trial aimed to investigate the effects of music therapy and/or adapted physical activity on physical performance and cognitive functioning in patients diagnosed with Alzheimer's disease. The participants were randomly assigned to one of four groups: Music therapy only (MT), Adapted physical exercise only (APA), music therapy and adapted physical activity combined (MT+APA), or a control group (CG).To assess physical performance, several tests were employed, including the timed up and go test, 6-minute walking test, 10-minute walking test, and short physical performance battery. Cognitive functioning was evaluated using the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE). Neuropsychiatric symptoms were assessed using the neuropsychiatric inventory (NPI), and sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). Results showed more significant improvements in physical performance, sleep quality , neuropsychiatric symptoms and cognitive functioning in the MT+APA group compared to the MT, APA and CG. The findings suggest that a combination of music therapy and adapted physical activity may be an effective intervention for improving physical performance and cognitive functioning in patients with Alzheimer's disease. Keywords: Alzheimer's disease, Older adults, Adapted physical Activity, Music therapy, Physical performance, Cognitive Functioning, Sleep quality
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/09/2022
Actual trial start date 11/09/2022
Anticipated date of last follow up 30/12/2022
Actual Last follow-up date 30/12/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Adapted physical activity Group 3 times per week 12 weeks Multicomponent physical activity program 15
Experimental Group Musictherapy Group 3 times per week 12 weeks Program of passive music therapy based on listenning to songs that have accompanied positive moments in the patient's personal life 15
Experimental Group Adapted physical activity and musictherapy group 3 times per week 12 weeks this group underwent both music therapy and physical rehabilitation concurrently 15
Control Group Control Group 12 weeks the control group will not undergo the treatment during the study. However, after the study concludes, the control group will receive the same protocol as the treatment group 15 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Age between 50-90 years -Mini-mental state examination (MMSE) score >19 -Body Mass Index (BMI) <30 -AD diagnosed according to NINCDS-ADRDA criteria -If the patient is receiving an anti-dementia or mood stabilizing medication, the dose must be stable for at least 3 months prior to inclusion -Contraindications to physical activity -Participation in high-intensity exercise > 2× per week -Body mass index (BMI) > 30 -Severe psychiatric illness -Alcohol or drug abuse in the past 2 years -Patients with congenital malformations (scoliosis, lower limb inequality, etc...). Aged: 65+ Year(s) 50 Year(s) 90 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 14/04/2022 the south ethical committee for protection of people
Ethics Committee Address
Street address City Postal code Country
Route El Ain, Km0 5, 3000, Sfax, Tunisie Sfax 3027 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Physical performance Before and after intervention
Primary Outcome Cognitive Before and after intervention
Primary Outcome Sleep quality Before and after intervention
Secondary Outcome neuropsychiatric symptoms Before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University Hospital Center of Monastir Farhat-Hached Avenue and 1st June Street 1995 Monastir 5000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
higher institute of sports and physical education ksar said 20 Rue des Travailleurs, Manouba, Tunisie Tunisia 2011 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of manouba 20 Rue des Travailleurs, Manouba, Tunisie Tunis 2010 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayoub Boulares boularesayoub@yahoo.com +33610113901 86 rue anatole france ronchin
City Postal code Country Position/Affiliation
ronchin 59790 France Phd student
Role Name Email Phone Street address
Public Enquiries Ayoub Boulares boularesayoub@yahoo.com +33610113901 86 rue anatole france ronchin
City Postal code Country Position/Affiliation
ronchin 59790 France Phd student
Role Name Email Phone Street address
Scientific Enquiries Nicolas Luigi Bragazzi robertobragazzi@gmail.com +393279769965 4700 keele street
City Postal code Country Position/Affiliation
Toronto ON M3J 1P3 Canada Doctor
Role Name Email Phone Street address
Scientific Enquiries Sabri Gaied Chortane sabrigaied1@gmail.com +21698525718 115 rue Sqanes
City Postal code Country Position/Affiliation
Monastir 5000 Tunisia Director of the Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes As part of our commitment to transparency and scientific collaboration, we plan to share the individual trial participant data in an anonymized manner. In accordance with the World Health Organization's (WHO) data sharing policy, this IPD sharing statement aims to promote the replicability of study results and facilitate further analysis by the scientific community. The individual trial participant data collected for this study includes demographic information, medical history, treatment interventions, and clinical outcomes. All personally identifiable information has been rigorously removed or anonymized to protect the confidentiality of the participants. Only anonymous identification codes are used to link the data to individual participants. Clinical Study Report 10 months -controlled -upon reasonable request
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