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.: PACTR202405804830163 Date of Approval: 15/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Yoga for Brain Wellness: Enhancing Cognitive Abilities in Aging Populations
Official scientific title Enhancing Cognitive Health in Elderly Individuals: The Impact of Hatha Yoga on Attention, Memory, and Reasoning: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Aging leads to physiological and psychological changes that compromise both mental and physical autonomy, as well as cognitive functions, thereby increasing the risk of anxiety and depression. The sedentary lifestyle typical of older individuals results in a deterioration of overall quality of life and well-being. This study aims to determine which is the best strategy (Yoga or physical and sports activity) to improve attention, memory, and reasoning in elderly individuals.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ECHOAMR
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 03/01/2023
Actual trial start date 03/01/2023
Anticipated date of last follow up 30/03/2023
Actual Last follow-up date 30/03/2023
Anticipated target sample size (number of participants) 62
Actual target sample size (number of participants) 45
Recruitment status Recruiting
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 Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hatha Yoga Three months Yoga Group (YOGA). During the central part of the yoga sessions, participants dedicated themselves to practicing various yoga postures, also known as Asana. These postures included the seated mountain pose, seated chair twist, seated warrior position, goddess pose with a twist, pigeon poses, and seated forward bend pose. The breathing techniques, known as Pranayama, involved the voluntary regulation of breath, incorporating methods such as forceful exhalation with passive inhalation, rapid inhalation and exhalation, as well as slow and rhythmic alternate nostril breathing. 15
Experimental Group Physical Activities and Sports Three months During the central part of the physical activity sessions, participants in the group engaged in low-intensity basketball exercises regularly. These exercises included the following elements: passes, dribbles, free throws, and fakes, organized in a circuit with size 5 basketballs (685–700 mm in circumference, 465–495 g). These balls were chosen for their lightness and flexibility, making them easier to grip and control, while also reducing muscle fatigue and minimizing joint tension. 15
Control Group Control group Three months During this experimental period, participants in this group did not engage in any type of physical activity and maintained their usual activities within the retirement home facility. 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
be aged between 65 and 80 years, have normal or corrected-to-normal vision, not have mental problems or a history of musculoskeletal disorders that could have affected their physical capacity. 1. Being under 65 years old or over 80 years old. 2. Having uncorrected vision problems or vision disorders that cannot be corrected. 3. Having mental health issues or a history of musculoskeletal disorders that could affect their physical capacity. Aged: 65+ Year(s) 65 Year(s) 80 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 27/11/2022 The Ethics Committee of the Faculty of Medicine of Sousse
Ethics Committee Address
Street address City Postal code Country
Avenue Mohamed Karoui, Sousse Sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The YOGA group showed significant improvements at T1 compared to T0 in all cognitive parameters (P < 0.001). Additionally, significant differences were found between the YOGA group and both APS and CONT groups for attention and reasoning at T1. These findings underscore Hatha yoga's potential to enhance mental well-being and cognitive function in the elderly population. January 3, 2023: pre-intervention T0. March 30, 2023: post-intervention T1
Secondary Outcome For the Yoga group, compared with the pre-test, the post-hoc test showed higher values at the post-test for attention scores (p < 0.001, g= 1.35). Additionally, the post-hoc test revealed significantly higher values for the Yoga group compared with the APS group and CONT group at the post-test for attention scores (p < 0.001). 2. For the Yoga group, compared with the pre-test, the post-hoc test showed higher values at the posttest for Memorization scores (p < 0.001, g=1.04). Additionally, the post-hoc test revealed a significantly higher value for the Yoga group compared with the CONT group at the posttest for the Memorization scores (p = 0.006). 3. In the Yoga group, there were higher values in reasoning scores at the post-test compared to the pre-test (p < 0.001, g= 1.82), as indicated by the post-hoc test. Moreover, significant differences were observed in reasoning scores at the post-test, with the Yoga group showing higher values compared to both the APS and CONT groups (p < 0.001) according to the post-hoc test January 3, 2023: pre-intervention T0. March 30, 2023: post-intervention T1
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sousse retirement home 126 Rue de Grenade, Sousse 4000, Tunisia Sousse 4000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
1High Institute of Sport and Physical Education Sfax Airport Road, 3.5 km Sfax 3000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor High Institute of Sport and Physical Education Sfax Airport Road, 3.5 km Sfax 3000 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rania Oueslati raniaoueslati777@gmail.com +21656131123 Kortoba Street, Kallaa Sghira,
City Postal code Country Position/Affiliation
Sousse 4021 Tunisia Doctor of Humanities and Social Sciences at High Institute of Sport and Physical Education Sfax
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdelkader Souissi gaddoursouissi@yahoo.com +21696366344 Kratten, Kerkennah
City Postal code Country Position/Affiliation
Sfax 3072 Tunisia Assistant Professor of Didactics at High Institute of Sport and Physical Education Gafsa
Role Name Email Phone Street address
Public Enquiries Riadh Dahmen riadh.dahmen@gmail.com +21622719177 El Ataya Kerkennah
City Postal code Country Position/Affiliation
Sfax 3055 Tunisia Professor in Humanities and Social Sciences at High Institute of Sport and Physical Education Sfax
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data (IPD) were gathered from 45 elderly individuals aged 65 to 80 living in a retirement home in Sousse, Tunisia. Selection criteria included age range, normal or corrected vision, and absence of mental or musculoskeletal issues affecting physical capacity. Initially, 62 potential participants were considered, with 14 failing to meet criteria and 3 declining participation. All provided informed consent. Following recruitment, participants were randomly assigned to three groups: yoga (YOGA), physical activities (APS), and control (CONT), each undergoing distinct interventions over 12 weeks, with assessments conducted before (T0) and after (T1). Interventions tailored to groups included yoga postures for YOGA, low-intensity basketball for APS, and no additional activities for CONT. Standardized tests, including the Raven Progressive Matrices Test for reasoning, Paper Folding Test for memory, and Wais Code Test for attention, were administered at T0 and T1 to assess cognitive function effects. In accordance with the principles of transparency and data sharing, I commit to making the participant data from this study available in a de-identified manner, in line with the guidelines of the World Health Organization (WHO). Participant data will be accessible to qualified researchers who wish to utilize them for scientific research purposes, while respecting confidentiality and ethics. I undertake to provide additional information on how to access participant data upon request. This initiative aims to foster scientific collaboration and contribute to the advancement of knowledge in the field of health and clinical research. Informed Consent Form,Statistical Analysis Plan,Study Protocol six months open
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