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.: PACTR202306580460880 Date of Approval: 12/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of an upper-limb aerobic exercise program for patients with spinal cord injury in northwestern Nigeria
Official scientific title Effectiveness of an upper-limb aerobic exercise program among patients with spinal cord injury in northwestern Nigeria: a randomized controlled trial
Brief summary describing the background and objectives of the trial Spinal cord injury (SCI) is a devastating injury with physical, psychosocial, and economic impacts, along with significant personal and social consequences. Immobility and cardiovascular complications are well-known to compromise the quality of life (QoL) of the victims. Upper-limb aerobic exercises (ULAE) may help to retrain and regain some of the abilities lost through SCI and enable the victims to live a full and optimal life. Arm ergometer and overhead pulley are ideal tools to train the upper limb for aerobics. However, randomized controlled trial evaluating the utility of ULAE using arm ergometer and overhead pulley among patients with SCI in the northwestern Nigeria is lacking. The purpose of this study is to determine the effectiveness of an ULAE program among SCI patients in northwestern Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/07/2023
Actual trial start date 01/02/2024
Anticipated date of last follow up 30/08/2024
Actual Last follow-up date 30/12/2024
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 46
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 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
Experimental Group Upper limb aerobic exercise program Three times per week for 8 weeks. Eight weeks intervention period and 14 weeks follow-up A bike portable under desk arm leg foot exerciser stationary ergometer (TDC T-C CA, Japan) with adjustable multi-level resistance system will be used to perform ULAE. The exercise protocol will be divided into three phases: warm-up phase, exercise phase and cool-down phase. During the warm-up, the participant will be instructed to pedal the ergometer for 5 minutes, exercise phase for 20 minutes and a cool down phase for 5 minutes. The resistance will be increased gradually, up to the desired intensity of 60% of maximal HR. After the arm ergometer exercise and adequate rest, the participants will be instructed to perform reciprocal or overhead pulley exercise using 85-inch reciprocal pulley (Samvsine, USA) for 10 minutes. 23
Control Group General exercise Three times per week for 8 weeks Eight weeks of intervention and 14 weeks follow-up The general exercise program include passive, active-assisted and free active range of motion exercises including the stretching and strengthening exercises for the upper and lower body to be performed in different positions such as sitting, prone, supine, quadruped, kneeling, and standing. Range of motion exercises will include the use of reciprocal pulley and strengthening exercises will involve the use of sand bags and dumb bells of different weight sizes. The exercise will be targeted to key muscles of body (i.e. deltoids, triceps, biceps, pectoralis, wrist flexors, wrist extensors, lower body the quadriceps, hamstrings, and gastrocnemius). Moderate intensity exercises will be employed which is safer for SCI people, as recommended by the ACSM. 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Participants must have received medical approval from their physicians as being fit to exercise. 2. Male or female aged 18–65 years old. 3. Diagnosed with SCI between 7th cervical (C7) and 5th lumbar (L5) with at least 3 months’ post injury. 4. Participants with upper limb muscle power of at least 3 based on gross muscle power testing . 5. Willing to participate and have signed the informed consent form. 1. Participants will be excluded from the study if they have any of the following: 2. Participants with SCI level other than C5 to L4. 3. Participants with less than 3 months’ post injury. 4. Having upper limb muscle power of less than 3. 5. Participants with serious or unstable cardiovascular or neurological disorder. Adult: 19 Year-44 Year,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
No 25/06/2023 BREC University of KwazuluNatal
Ethics Committee Address
Street address City Postal code Country
University of KwaZulu-Natal Durban 10000 South Africa
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 14/04/2021 Aminu Kano Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Zaria road, Kano, Nigeria Kano P.M.B3452 Nigeria
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 15/05/2021 Kano state ministry of health
Ethics Committee Address
Street address City Postal code Country
2nd and 3rd floor post office road Kano P.M.B3066 Nigeria
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 24/05/2021 National orthopaedic hospital Dala
Ethics Committee Address
Street address City Postal code Country
Dala district, Kano Kano P.M.B3087 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cardiovascular product systolic blood pressure multiply by heart rate and function measured by Spinal Cord Independence Measure Version III (SCIM-III) Baseline, 8 weeks post-intervention, and 14 weeks follow-up
Secondary Outcome Blood pressure and quality of life measured by WHOQOL-BREF Baseline, 8 weeks post-intervention, and 14 weeks follow-up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aminu Kano Teaching Hospital Zaria Road, Gyadi Gyadi, Kano Kano 700101 Nigeria
Murtala Muhammad Specialist Hospital Kofar Mata Rd, Kano City, Kano Kano 700224, Nigeria
National Orthopaedic Hospital Dala Dala, Kano Kano 700252 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Fatima Kachalla Gujba First Avenue, Gwarinpa, Nigeria Abuja 10000 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fatima Kachalla Gujba First Avenue, Gwarinpa, Nigeria Abuja 10000 Nigeria Self
COLLABORATORS
Name Street address City Postal code Country
Sonill Maharaj University of KwaZulu-Natal South Africa Durban 4000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatima Gujba teemakg@gmail.com +2347034681602 First Avenue Gwarinpa, Nigeria
City Postal code Country Position/Affiliation
Abuja 40000 Nigeria postgraduate student
Role Name Email Phone Street address
Scientific Enquiries Sonill Sooknunan Maharaj maharajss@ukzn.ac.za +27834611413 University of KwaZulu-Natal
City Postal code Country Position/Affiliation
Durban 4000 South Africa Supervisor
Role Name Email Phone Street address
Public Enquiries Bashir Kaka kakaB@ukzn.ac.za +23428460237 University of KwaZulu-Natal
City Postal code Country Position/Affiliation
Durban 40000 South Africa Cosupervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD sharing statement “Data obtained through this study may be provided to the qualified researchers with academic interest in spinal cord injury. Data or samples shared will be coded, with no personal information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. “Data requests can be submitted 6 months after study conclusion and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.” Access Criteria: ““Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approvals. For more information or to submit a request for data please contact teemakg@gmail.com. Informed Consent Form Data will be available within six after study has been completed University of Kwazulu-Natal Library Hospitals in North Western Nigeria where data was collected Journals Seminars Conferences
URL Results Available Results Summary Result Posting Date First Journal Publication Date
teemakg@gmail.com 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