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.: PACTR202008599549772 Date of Approval: 05/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title aerobic exercises for low back pain
Official scientific title effect of aerobic exercises on patients with chronic mechanical low back pain: A randomized blinded clinical trial
Brief summary describing the background and objectives of the trial Chronic mechanical low Back pain (CMLBP) is defined as low back pain (LBP) lasting more than 3 months. It is the most common complaint of the working-age population. In addition to human suffering, it causes a substantial economic burden due to the wide use of medical services and absence from work The treatment programs that emphasized conditioning exercise have suggested to significantly enhance cardio-respiratory fitness, increase muscular strength and endurance, improve flexibility, decrease perception of pain, depression and disability, thus improving functional status, and facilitating early return to work thus this study may be needed to clarify the efficacy of aerobic exercises for subjects with CMLBP .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 06/08/2020
Actual trial start date
Anticipated date of last follow up 24/11/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group trunk flexion exercises program 3 sessions per week 4 weeks progressed trunk flexion exercises 25 Active-Treatment of Control Group
Experimental Group aerobic exercises program 4 weeks aerobic conditioning exercises program 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
mild to moderate disability body mass index less than 30 20-40 years old visual or auditory problems any neurological symptoms Adult: 19 Year-44 Year 20 Year(s) 40 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 03/08/2020 research ethics committe of faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzayat street cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VO2 max immediately before and after the treatment program
Secondary Outcome pain intensity immediately before and after the treatment program
Secondary Outcome functional disability immediately before and after the treatment program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
clinic of faculty of physical therapy pharos university elmahmoudeya street alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aliaa M Elabd Sabry aboallam Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor aliaa elabd sabry aboallam street alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Omar M Elabd Hamdy kandil Shebin Elkom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aliaa Elabd aliaelabd88@gmail.com 00201069352446 sabry aboallam street
City Postal code Country Position/Affiliation
alexandria Egypt pharos university faculty of physical therapy lecturer
Role Name Email Phone Street address
Public Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 sabry aboallam street
City Postal code Country Position/Affiliation
alexandria Egypt pharos university faculty of physical therapy lecturer
Role Name Email Phone Street address
Scientific Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 sabry aboallam street
City Postal code Country Position/Affiliation
alexandria Egypt pharos university faculty of physical therapy lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collocted during the Trial Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediatly after publication Any one
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