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.: PACTR202408541705549 Date of Approval: 13/08/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Combined Effects of Exercise Training with Probiotics on Physical, Motor, Cognitive, and Affective Functions in Patients with Stroke
Official scientific title Combined Effects of Exercise Training with Probiotics on Physical, Motor, Cognitive, and Affective Functions in Patients with Stroke
Brief summary describing the background and objectives of the trial Several exercise protocols have been shown to positively modify various stroke-related sequeale and promote clinical recovery (Grau-Sanchez et al., 2020; Hamzei et al., 2020; Li et al., 2023). Apart from exercise, however, diet is another non-pharmacological intervention in stroke rehabilitation (Oliveira et al., 2019). Evidence show that supplement, such as high protein, improve motor functions and clinical recovery of stroke survivors (Okon et al., 2021; VanDerwerker et al., 2018). Moreover, recent empirical data in stroke patients indicate a bi-directional association between the gut microbiota and brain called “microbial-gut-brain axis” (Long et al., 2022). A normal synergy between gut and brain in stroke patients enhance positive immune response, promote normal endocrine environment, and induce and promote neuro-regeneration (Long et al., 2022; Wang et al., 2023). Unfortunately, an incidence of stroke disrupts synergetic communication between the gut and brain, worsening the stroke outcome (Long et al., 2022; Wang et al., 2023). Probiotics is one of the main microbiota that regulates the “microbial-gut-brain axis” (Long et al., 2022; Wang et al., 2023; Collins et al., 2009). Probiotics are food supplements composing of living, safe microbial that are beneficial to man’s health (Hill et al., 2014). However, many of the studies investigating the importance of probiotics in stroke are undertaken using stroke animal models but not in human (Long et al., 2022; Wang et al., 2023; Martínez-Guardado et al., 2022). Meanwhile, while studies have shown promising outcomes while combining exercise and other forms of food supplements in stroke rehabilitation, there is paucity of data on the combined effects of exercise and probiotics among individuals with stroke (Martínez-Guardado et al., 2022; Liu et al., 2022). This study is aimed to determine the effects of exercise with probiotics on physical, motor, cognitive, and affective functions in patients with stroke.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Nervous System Diseases,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 02/10/2024
Actual trial start date 30/12/2024
Anticipated date of last follow up 02/04/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Exercise Training Alone three times weekly for 8 weeks 8 weeks Participants in this group will undergo progressive, supervised 8-week, 90-minute exercise intervention for three times weekly, which will involve range of motion (ROM) exercises, Strengthening exercises (proprioceptive neuromuscular facilitation techniques, Theraband exercises), balance exercises (step-ups, chair rises, wall exercise, marching, toe rises, ball kicking, sudden stop and turn on motion), upper limb functional exercises (opening of drawers, writing, hand exerciser, picking and counting), and endurance exercises (treadmill exercise, riding a stationary bicycle ergometry, stepping exercise) (Takeuchi et al., 2019; Duncan et al., 2003). The ROM, strengthening, balance and upper limb exercises will be individualized and the repetitions and sets gradually increase but will largely involve two sets of 10 repetitions. Endurance exercise will also be gradually increase in speed and resistance within 20.0–30.0% of 1 repetition maximum. The endurance training will be 30 minutes maximum (Takeuchi et al., 2019; Duncan et al., 2003). The exercise intervention will be on alternate days with at least one day of rest. 25 Active-Treatment of Control Group
Control Group Probiotics Alone One daily capsule of probiotics 8 weeks Participants in this group will receive probiotics for eight weeks. Participants will be required to take a daily capsule of probiotics containing 3.3 billion CFU Lactobacillus rhamnosus and Bifidobacterium lactis for 8 weeks. Participants will be asked to take it after breakfast (Suez et al., 2019; Long et al., 2022; Ruiz Gonzalez et al., 2024). 25 Active-Treatment of Control Group
Experimental Group Exercise Training with Probiotics Exercise training will be undertaken three times a week for 8 weeks with daily capsule of probiotics for 8 weeks. 8 weeks Participant in this group will receive both progressive, supervised 8-week, 90-minute exercise intervention for three times weekly and daily capsule of probiotics containing 3.3 billion CFU Lactobacillus rhamnosus and Bifidobacterium lactis, concurrently. In this group, if falling on exercise intervention day, the participants must have taken the daily dose of the probiotics at least 30 minutes before the exercise intervention (Takeuchi et al., 2019). 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with clinical and radiological diagnosis (Computed Tomography Scan or Magnetic Resonance Imaging) of stroke. Patients who are 18 years and older. Patients with no major communication problem preventing them from understanding the protocol. Patients with pre-stroke modified Rankin Score other than 0 or any physical disability before stroke. Patients with other neurological problems, e.g. Parkinson’s disease Patients who are already on Probiotics supplement. Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 27/12/2024 Research Ethics Committee Osun State University Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Idi-seke, station road Osogbo 230221 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Physical and motor functions before intervention, at 4 week, and 8 week of intervention
Secondary Outcome Cognitive and affective functions Before intervention, at 4 week, and 8 week of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Osun State University Teaching Hospital Idi-seke, station road Osogbo Nigeria
State Specialist Hospital Asubiaro Street Isale Osun Osogbo Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adekola Ademoyegun Idi-seke, Station road Osogbo Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Adekola Ademoyegun Idi-seke, station road Osogbo Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof. Taofeek Awotidebe Road 1, OAU Ile Ife Nigeria
Dr. Olayemi Olanrewaju Idi-seke, station road Osogbo Nigeria
Rasaq Wasiu Idi-seke, station road Osogbo Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adekola Ademoyegun aademoyegun@gmail.com +2348066476718 Idi-seke, station road
City Postal code Country Position/Affiliation
Osogbo Nigeria Physiotherapist Osun State University Teaching Hospital Osogbo
Role Name Email Phone Street address
Public Enquiries Wasiu Rasaq direct2wharley@gmail.com +2348108113112 Idi-seke, station road
City Postal code Country Position/Affiliation
Osogbo Nigeria Physiotherapist Osun State University Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Taofeek Awotidebe tidebet@yahoo.com +2348037196021 OAU road one
City Postal code Country Position/Affiliation
Ile Ife Nigeria Professor Obafemi Awolowo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this trial, after deidentification (text, tables, figures, and appendices). Study Protocol Beginning 9 months and ending 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 30/12/2024 Ethical approval 30 Dec 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 30/12/2024 Ethical committee recommendation 75 96
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 30/12/2024 Ethical approval now granted Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 30/12/2024 To accommodate more participants recommended by the ethics committee State Specialist Hospital, Asubiaro Street Isale Osun, Osogbo, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 30/12/2024 To upload ethical approval FALSE, Research Ethics Committee Osun State University Teaching Hospital , Idi-seke, station road, Osogbo, 230221, Nigeria, 30 Jul 2024, , +2347033328615, researchethicscommittee.uth@yahoo.com, TRUE, Research Ethics Committee Osun State University Teaching Hospital , Idi-seke, station road, Osogbo, 230221, Nigeria, 30 Jul 2024, 27 Dec 2024, +2347033328615, researchethicscommittee.uth@yahoo.com, 31737_29835_4737.pdf