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.: PACTR202306912191110 Date of Approval: 15/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of physical activity on functional capacities on older adults with sarcopenic obesity
Official scientific title Effects of physical activity program on body composition, physical performance and neuromuscular strategies during walking in older adults with sarcopenic obesity.
Brief summary describing the background and objectives of the trial Sarcopenic obesity in older adults is associated with reduced muscle mass, strength, and functional limitations, leading to increased functional limitations and risk of falls. However, the potential impact of specific physical activity regimens on biomechanical gait parameters and neuromuscular strategies around the ankle joint in older adults with SO remains largely unexplored. This knowledge gap significantly limits our understanding of effective strategies to enhance walking ability in older adults, including those with specific conditions, ultimately impeding their independence and overall well-being. The objective of this study was to investigate the effectiveness of a 24-week Posture, Strengthening, and Motricity program in improving body composition, physical performance, neuromuscular strategies and biomechanical gait parameters in older adults with sarcopenic obesity
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) PhASO
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/02/2022
Actual trial start date 31/08/2022
Anticipated date of last follow up 21/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 40
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
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Posture Strengthening and motricity program The PSM program spanned over 24 weeks and consisted of 2 sessions of 60 minutes each week, for a total of 48 sessions. 24 weeks The program's progressiveness was based on two aspects: a quantitative aspect related to the training load (volume/intensity) and a qualitative aspect related to the type of exercises (muscle strengthening, balance, and motor skills exercises). According to the quantitative aspect, the PSM program was structured into 3 micro-cycles of 16 sessions each: the first micro-cycle focused on volume, the second on intensity, and the third micro-cycle aimed to balance both volume and intensity. The program's progressiveness was based on two aspects: a quantitative aspect related to the training load (volume/intensity) and a qualitative aspect related to the type of exercises (muscle strengthening, balance, and motor skills exercises). According to the quantitative aspect, the PSM program was structured into 3 micro-cycles of 16 sessions each: the first micro-cycle focused on volume, the second on intensity, and the third micro-cycle aimed to balance both volume and intensity. The program's progressiveness was based on two aspects: a quantitative aspect related to the training load (volume/intensity) and a qualitative aspect related to the type of exercises (muscle strengthening, balance, and motor skills exercises). According to the quantitative aspect, the PSM program was structured into 3 micro-cycles of 16 sessions each: the first micro-cycle focused on volume, the second on intensity, and the third micro-cycle aimed to balance both volume and intensity. According to the qualitative aspect, the PSM program was divided into 3 micro-cycles based on the type of exercises. The first cycle mainly focused on motor skills exercises (50% to 70% of the session), the second on balance and muscle strengthening exercises, and the third cycle offered all types of exercises in a balanced way. The quantity of the different types of exercise was regulated every week. 20
Control Group No intervention No intervention Only pre-test and post-test assessments. No intervention. Only pre-test and post-test assessments. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- BMI > 30 Kg/m², - A Handgrip force (HF) <17 N, - Gait speed <1.0 m/s50, - Be over 65 years of age, - Able to verbally communicate with the experimenters, and physically independent - The presence of neurological or cognitive impairments, - Severe cardiovascular problems, - Severe musculoskeletal deformities or injuries of the lower limb, - Comorbidities or chronic diseases, - Medication use that could interfere with testing, - A Montreal Cognitive Assessment (MoCA) test score of <26 Aged: 65+ Year(s) 65 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 22/02/2022 South Committee for the Protection of Persons
Ethics Committee Address
Street address City Postal code Country
Avenue Majida BOULILA Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome After the PSM program, TG showed a significant increase in LBM (+10%, p<0.05) and a decrease in FBM (-12.4%, p<0.05) and demonstrated improved physical performance in the various exercises of the senior fitness test (p<0.005). . Additionally, the durations of the initial left and right double stance phases (-4.1%, -4%, respectively) and the left and right pre-swing phases (-3%, -3%, respectively; p<0.05) decreased. Moreover, TG demonstrated a reduction in CoP velocity (-26%, p<0.01). Notably, TG also displayed increased GRFv (+16%, p<0.05). These gait modifications were associated with a decreased muscle activity in SOL during the first stance phase (-17.5%; p<0.05) and pre-swing phase (-15.1%; p<0.05). Additionally, TA activity decreased during the first double stance phase (-18.6%; p<0.05) and single stance phase (-26.6%; p<0.01), while GM activity decreased during the pre-swing phase (-23.9%; p<0.01). Before and after intervention
Primary Outcome Trained group exhibited an increase in comfortable walking speed (+80%, p<0.001) and step length (+38%, p<0.05) Before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CHU Avenue Ibn El Jazzar Sousse 4000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
doctoral scholarship Ministry of Higher Education and Scientific Research Tunis 1002 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FERHI 20 Rue des Travailleurs Manouba 2010 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Sabri Gaied sabrigaied@gmail.com 0021651255230 20 Rue des Travailleurs
City Postal code Country Position/Affiliation
Manouba 2010 Tunisia Prof.
Role Name Email Phone Street address
Principal Investigator HAMZA FERHI ferhihamza1996@gmail.com 0021655100200 20 Rue des Travailleurs
City Postal code Country Position/Affiliation
Manouba 2010 Tunisia PhD
Role Name Email Phone Street address
Public Enquiries Wael maktouf waelmaktouf1@gmail.com 0021622450231 20 Rue des Travailleurs
City Postal code Country Position/Affiliation
Manouba 2010 Tunisia DR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices) Clinical Study Report 1 year Contrôlé
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