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.: PACTR202204649337183 Date of Approval: 19/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF RESPIRATORY MUSCLE TRAINING ON CARDIOPULMONARY ENDURANCE AND WALKING SPEED AMONG AMBULANT STROKE SURVIVORS
Official scientific title EFFECTS OF RESPIRATORY MUSCLE TRAINING ON CARDIOPULMONARY ENDURANCE AND WALKING SPEED AMONG AMBULANT STROKE SURVIVORS
Brief summary describing the background and objectives of the trial Pulmonary function is often impaired in individuals with stroke. Decreased lung volume, decreased pulmonary perfusion and altered chest wall excursions are all common findings. The decreased respiratory output is accompanied by increased oxygen demands required during activity using altered and unfamiliar movement patterns (O’Sullivan et al, 2014). The poor lung function observed in stroke survivors has been found to be approximately 50% below that of age and sex-adjusted norms (Mackay- Lyons, 2002). Reduction of respiratory function along with hemiparesis leads not only to decreased endurance, dyspnea and increased sedentary behavior, but also an increased risk of another stroke ( Van der Palen et al, 2004). The objective of this study will be to determine the efficacy of respiratory muscle training on cardiopulmonary endurance and walking speed among ambulant stroke survivors.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RMT
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 15/01/2022
Actual trial start date 20/02/2022
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date 30/06/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 55
Recruitment status Recruiting
Publication URL Nil
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Exercise therapy for stroke 3 sessions weekly 6 weeks It’s a rehabilitation program for stroke patients which involves exercise training to strengthen weak muscles, break spasticity and re educate normal functioning of affected muscles 30 Active-Treatment of Control Group
Experimental Group Exercise therapy for stroke patients and respiratory muscle training 3 sessions of 1 hour weekly 6 weeks Exercise therapy rehabilitation program in addition to respiratory muscle training(RMT). RMT involves the use of a breather to train the respiratory muscles. It has different resistance on both inspiratory and expiratory phase which helps to exercise and strengthen the respiratory muscles. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. A single episode of stroke 2. Ability to carry out sit to stand transfer independently 3. Can ambulate independently with or without assistive device 4. Well oriented, can communicate and obey simple commands 5. Controlled blood pressure of less than 140/100mmHg 1. Unstable Angina in the last 3 months 2. Myocardial infarction in the last 3 months 3. Resting heart rate of more than 120bpm 4. Stroke patients on wheelchair Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 23/02/2022 University of Uyo Teaching Hospital institutional health research ethical committee
Ethics Committee Address
Street address City Postal code Country
Abak road Uyo Uyo 052 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Respiratory Muscle training Walking speed and cardiopulmonary endurance all measured in distance and time
Secondary Outcome Cardiopulmonary Endurance Six minutes walk test. The distance covered during the test is measured pre intervention, 3 weeks into intervention and post intervention
Secondary Outcome Walking Speed using the gait speed test Gait Speed Test. The time used in covering 4 meters is recorded pre intervention, mid intervention and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Uyo Teaching Hospital Abak road Uyo Akwa Ibom State 234 Nigeria
General Hospital Ikot Ekpene Akwa ibom State 052 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Tega Jewel 223 Ikot Ekpene Rd Uyo 053 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tega Jewel 223 Ikot Ekpene Road Uyo 052 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Edidiong Tega Jeweltega@gmail.com +2348035503658 223 Ikot Ekpene Road, Uyo
City Postal code Country Position/Affiliation
Uyo Akwa Ibom State 052 Nigeria Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Titilope Ajepe tigbari@unilag.edu.ng +2348066704593 Department of Physiotherapy, University of Lagos
City Postal code Country Position/Affiliation
Lagos 041 Nigeria Supervisor
Role Name Email Phone Street address
Public Enquiries Edidiong Tega jeweltega@gmail.com +2348035503658 Department of Physiotherapy University of Lagos
City Postal code Country Position/Affiliation
Lagos 052 Nigeria Public Enquirer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial will be available for sharing. Informed Consent Form,Study Protocol From Aug 2022 to July 2023 Not Available yet
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available yet 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