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.: PACTR202205516974527 Date of Approval: 16/05/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Conventional physiotherapy exercises versus medication only in ischemic intermittent claudication: a randomized controlled trial
Official scientific title additional exercises versus traditional medical treatment for ischemic intermittent claudications
Brief summary describing the background and objectives of the trial Ischemic intermittent claudication is a chronic disabling condition mainly caused by atherosclerosis and is the first symptom of peripheral arterial disease (PAD). And characterized by leg pain, aching, cramping, or fatigue triggered by walking and relieved by rest. the aim is to evaluate the additive effect of physiotherapy exercises on the usual medical treatment protocol for the management of intermittent claudications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/01/2021
Actual trial start date
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group medical treatment only vasodilators twice per day 3 months naftidrofuryl 200 mg twice daily 30 Active-Treatment of Control Group
Experimental Group conventional exercises 3 sets/day 3 months 1-Heel raise: (a) Instruct the patients to stand with their feet flat on the floor with the extension of both knees.(b) Ask them to rise up on their toes as high as possible, after a slight pause at the top position, instruct them to slowly lower their heels back to the standing position .(c) Each patient will be asked to perform this exercise till his maximum repetition to reach the onset of the claudication pain. 2-Towel calf stretch: (a) Patients will obtain a long bath towel. (b) Patients will be seated on the bed with their legs out in front of them. (c) Patients will wrap the towel around the ball of their feet just below their toes. Patients gently will pull the towel. Allowing their feet to slowly bend up toward their knees while keeping their knees straight . (d) The stretching position was held for - seconds, and then slowly release the stretch. (e) Patients will repeat the stretch till maximum tolerated pain. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(a) Patients with mild to moderate intermittent claudication (according to Rutherford classification) [5]. (b) Both sexes with ages ranged from 50 to 65 years. (c) All patients enrolled in the study gave their informed consent. (d) The patients were suffering from spasmodic pain in the calf, thigh, or buttocks that limited walking ability and that was relieved by rest within 10 minutes. (e) Patients with Ankle Brachial Index (ABI) ranged from 0.9 to 0.5. (a) Fontain stage (I) PAD (asymptomatic disease) and Fontain stage (III) PAD (leg pain at rest). (b) Patients with severe symptomatic coronary artery disease and cerebrovascular disease. (c) Patients with poorly controlled blood pressure. (d) Those who underwent vascular operations or angioplasty within the previous year. (e) Dementia or physical/mental incapacity to perform study requirements. (f) Musculoskeletal disorders in lower limbs that may mimic the symptoms of intermittent claudication. (g) Active cancer, renal disease, or liver disease. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 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 01/01/2021 Al Azhar University ethics committee
Ethics Committee Address
Street address City Postal code Country
Al- Mokhyam Aldaem St. Al-Azhar University, Faculty of Medicine Cairo 11765 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assessment of the absolute claudication distance (ACD) and peak walking time (PWT). at base line and 3 months later
Secondary Outcome Walking Impairment Questionnaire (WIQ): Patients will be asked to rate the degree of difficulty of various activities with responses ranging from 0 (unable) to 4 (none). at base line and 3 months later
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Azhar University hospital Al-Hussien University hospital, Drrasa Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Abdelhfeez Moshrif Al-Azhar University square Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AlAzhar University Al-mokhyam aldayem st. Cairo Egypt University
Secondary Sponsor AlHussien hospital Drrasa st. Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Ali hanyaly79@yahoo.com +201061590284 Almokattam st.
City Postal code Country Position/Affiliation
Cairo Egypt assist Professor of rheumatology
Role Name Email Phone Street address
Public Enquiries Abdelhfeez Moshrif Dr.moshrif@live.com +201062930120 Shattura
City Postal code Country Position/Affiliation
Cairo Egypt assist Professor of rheumatology
Role Name Email Phone Street address
Scientific Enquiries Khalid Hussein kh1121992@gmail.com +201144015278 Al-Azhar University square
City Postal code Country Position/Affiliation
Assiut Egypt resident physician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available. Statistical Analysis Plan,Study Protocol 1 year upon request the access is open for all researchers upon reasonable request from the principal investigator
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