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.: PACTR202402571342655 Date of Approval: 02/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of physiotherapy exercises on pain and function in patients with atherosclerotic ischemic claudication
Official scientific title Conventional physiotherapy exercises versus medication only in ischemic intermittent claudication: a randomized controlled trial
Brief summary describing the background and objectives of the trial Ischemic intermittent claudication is the first sign of peripheral artery disease (PAD), an inactive chronic disease caused primarily by atherosclerosis. It is usually characterized by leg pain, aches, cramps, or fatigue when walking, which improves with rest. Physical therapy, including a guided exercise program, is often recommended as the first treatment for sprains. Therefore, the aim of this study was to compare the effects of traditional physical therapy exercises in the form of heel raises and calf stretches with drugs and drugs alone in intermittent claudication
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 01/05/2021
Actual trial start date 01/05/2021
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date 30/11/2021
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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
Experimental Group Physiotherapy exercises on the lower limb plus traditional medical treatment Three months The patients were instructed to perform three sets/day, each set included 10 repetitions for three months. The patients were first told to stand with their feet flat on the floor and both knees extended before beginning the heel-raise exercise. They were then asked to rise up on their toes as high as possible, and after a slight pause at the top position, they were instructed to slowly lower their heels back to the standing position. To induce claudication pain, each patient was instructed to complete this exercise up to their maximum number of repetitions. As for the towel calf stretch, the patient were first asked to dress in a long bath towel. They were then seated on the bed with their legs out in front of them. They then proceeded to wrap the towel around the ball of their feet, just below their toes. The patients then gently pulled the towel, allowing their feet to slowly bend up toward their knees while keeping their knees straight. The stretching position was held for seconds, and then released slowly. The whole procedure was repeated till their maximum pain tolerance. 40
Control Group Medications only Three months Patients in group B were on their medical treatment only. 2.5. Medical treatment Atorvastatin (40 mg or 80 mg) or rosuvastatin (20 mg or 40 mg), Aspirin (usually 81 mg/d; range75-325 mg/d), and Cilostazol dose 100 mg twice daily at least 30 minutes before or 2 hours after breakfast and supper were given to the patients as part of their medical treatment. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(a) patients with mild to severe intermittent claudication. (b) People of both sexes, 45 to 65 years old. (c) All of the study participants provided their informed consent. (d) The patients had a spasmodic calf, thigh, or buttock pain that interfered with their ability to walk and was resolved by rest within 10 minutes. (e) The Ankle Brachial Index (ABI) of the patients ranged from 0.9 to 0.5. a) PAD (asymptomatic disease) Fontaine stage (I) and PAD Fontaine stage (III) (leg pain at rest). b) Patients with significant symptoms of cerebrovascular illness and coronary artery disease c).People whose blood pressure is poorly managed. (d) Patients who had angioplasty or vascular surgery within the past year. (e) Dementia or a physical or mental inability to complete the necessary study tasks. (f) Lower limb musculoskeletal conditions can mirror the signs of intermittent claudication. (g) Liver disease, kidney illness, or active malignancy. Middle Aged: 45 Year(s)-64 Year(s) 45 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 01/01/2018 faculty of medicine Ethics committee
Ethics Committee Address
Street address City Postal code Country
1 Al-Azhar University square Assiut 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The potential beneficial effects of physiotherapy exercises on pain and function in patients with atherosclerotic claudication using Absolute claudication distance (ACD) and maximal walking speed were measured using an electric treadmill (bodywork sport 1500). (PWT). Patients' responses were logged using the Walking Impairment Questionnaire (WIQ) at the beginning of the trial and three months post intervention
Secondary Outcome Evaluation of the potential side effects or complications. at baseline and three months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic 1 Al-Azhar University square Assiut 71524 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funding 1 Al-Azhar University square Assiut 71524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohammed Elsaghir 1 Al-Azhar University Square Assiut 71524 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Elhewy elsagher2030@azhar.edu.eg +2093467239 1 Al-Azhar University Square
City Postal code Country Position/Affiliation
Assiut 71524 Egypt Lecturer of vascular surgery
Role Name Email Phone Street address
Scientific Enquiries Hany Aly Hanyaly79@yahoo.com +2356348 12 Quattamya hights st.
City Postal code Country Position/Affiliation
Cairo Egypt Associate professor of rheumatology
Role Name Email Phone Street address
Public Enquiries Abdelhfeez Moshrif Dr.moshrif@live.com +201062930120 1 Al-Azhar University Square
City Postal code Country Position/Affiliation
Assiut Egypt Associate professor of rheumatology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All collected IPD that underlie results of the study will be available upon reasonable request Clinical Study Report One year Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 26/01/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 26/01/2024 Result - 26/01/2024 Result - 26/01/2024 Result - 26/01/2024 Result - 26/01/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information