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.: PACTR202308813785696 Date of Approval: 03/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The acute effects of a 20-minute exercise snacking versus continuous aerobic exercise on fatigue, mood, and affect among stroke survivors.
Official scientific title The acute effects of a 20-minute exercise snacking versus continuous aerobic exercise on fatigue, mood, and affect among stroke survivors.
Brief summary describing the background and objectives of the trial Stroke is the leading cause of physical and neurological impairments and death (Murphy & Werring, 2020), especially in low-income and low-middle-income countries (Saini et al., 2021). As of 2019, about 101 million persons had a stroke, resulting in six million deaths (Feigin et al., 2021). Fatigue, an excessive feeling of mental or physical exhaustion is an important symptom of stroke that is often neglected in routine clinical care. However, it is associated with poor health outcomes (Guzik et al.2017). Additionally, previous studies have shown that stroke survivors are predisposed to negative moods as a result of functional limitations, and other problems associated with the condition (Barker-Collo, 2007; Loubinoux et al., 2012; Medeiros et al., 2020). This mood and affect problems may further worsen fatigue, resulting in a fatigue-mood cycle. The literature has documented exercise to improve stroke survivors’ general health and well-being and enhance mood and physical activity (Han et al., 2017). A previous study has shown that exercise decreases fatigue only when carried out for at least 20 minutes (Loy et al., 2013). “Exercise snacks”, described as breaking up a single bout of exercise into several smaller bouts spaced throughout the day, have been proposed to be a substitute for longer bouts of exercise. Studies exploring the effects of exercise snacking on fatigue, mood, or affect among stroke survivors are scarce. In addition, there is a dearth of studies comparing the effect of exercise snacking with continuous exercise on these clinical parameters. Therefore, the aims of this study are to determine the acute effects of a 20-minute exercise snacking on physical fatigue, emotional fatigue, mental fatigue, mood, and affect among stroke survivors and to determine if there will be a significant difference between the effects of a 20- minute continuous aerobic exercise and 20- minute exercise snacking on these outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Nervous System Diseases,Stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 19/06/2023
Actual trial start date
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants)
Recruitment status Not yet 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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group 20 MINUTES OF CONTNOUS AEROBIC EXERCISE 20-minute continuous aerobic exercise. Pre and post-intervention assessment includes; blood pressure, heart rate, mood and affect with fatigue. Each participant will begin with a warm-up which includes pedaling an unloaded bicycle ergometer at a self-selected pace. The workload will be reduced if the patient cannot tolerate it and the intervention will be terminated if symptoms limit the participants from continuing the intervention. The termination criteria are dizziness, shortness of breath, pre-syncope, cyanosis, paleness,>10mmHg drop in systolic blood pressure, exhaustion, and bradycardia. Participants in the continuous aerobic exercise group will engage in a moderate-intensity exercise ( as determined by the 0-10 Borg rating of perceived exertion) for 20 minutes. After the intervention, participants will fill out the Visual analogue mood scale (VAMS), Positive and Negative Affect Schedule (PANAS), and multidimensional fatigue inventory scale. 28 Active-Treatment of Control Group
Experimental Group 20 minutes of exercise snacking 20-minute exercise snacking group broken into bouts of ten minutes with a break of 5 minutes between the sets. Pre and post-intervention assessment includes; blood pressure, heart rate, mood and affect with fatigue. Each participant will begin with a warm-up which includes pedaling an unloaded bicycle ergometer at a self-selected pace. The workload will be reduced if the patient cannot tolerate it and the intervention will be terminated if symptoms limit the participants from continuing the intervention. The termination criteria are dizziness, shortness of breath, pre-syncope, cyanosis, paleness,>10mmHg drop in systolic blood pressure, exhaustion, and bradycardia. Participants in the 20-minute exercise snacking group will pedal the bicycle ergometer for two sets of ten minutes each with a break of 5 minutes between the sets. After the intervention, participants will fill out the Visual analogue mood scale (VAMS), Positive and Negative Affect Schedule (PANAS), and multidimensional fatigue inventory scale. 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Stroke survivors must be literate in either English or Yoruba language. 2) Participants must be 18 years or older 3) Participants who have been diagnosed with stroke 3 months before. 4) Stroke survivors who understand basic commands. 1) Participants lesser than 18 years of age. 2) Individuals who cannot speak English or the Yoruba language 3) Individuals not orientated in time, place, and person. 4) Stroke survivors who have difficulty with speech and expressing their emotions. 5) Stroke survivors who suffer from other conditions e.g. cognitive impairment and cancer. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 07/06/2023 Directorate of research innovation and partnerships
Ethics Committee Address
Street address City Postal code Country
Ede, Osun State Osogbo 230221 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fatigue Pre and Post Intervention
Secondary Outcome Mood, Affect Pre and Post Intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Osun Teaching Hospital Station Road Idi Seke Osogbo Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Atakpu Gabriella Redeemers University, Ede, Osun State Ede Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Idowu Opeyemi Station Road Idi Seke Osogbo Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Atakpu Gabriella Redeemers University, Ede, Osun State Ede Nigeria
Kadeba Bisola 16th Mokin Street, Ijapo estate, Akure Akure Nigeria
Opalana Tinuoluwa Oduduwa lane, Aladi Street, Ologuneru, Eleyele, Ibadan Ibadan Nigeria
Dr. Idowu Opeyemi Redeemer University Ede, Osun state Ede Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Opeyemi Idowu idowuope@run.edu.ng +2347036872825 Redeemers University, Ede
City Postal code Country Position/Affiliation
Ede Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Gabriella Atakpu gabriellaatakpu2002@gmail.com +2348155235320 Redeemers University, Ede
City Postal code Country Position/Affiliation
Ede Nigeria Undergraduate Student
Role Name Email Phone Street address
Scientific Enquiries Bisola Kadeba Bisolajoy225@gmail.com +2348077894423 16th mokin street, Ijapo Estate, Akure
City Postal code Country Position/Affiliation
Akure Nigeria Undergraduate Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Patient demographics, and outcomes will be shared after de-identification. Informed Consent Form 1 year after final publication. Will be made available on request sent to the authors.
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