- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05503537
Effect of Post-isometric Relaxation Technique and Static Stretching on Length of the Calf Muscles in Post-CABG Patients
Study Overview
Status
Conditions
Detailed Description
Coronary artery bypass grafting is one of the common procedure used for coronary artery disease. It has several musculoskeletal and cardiopulmonary complications. Rehabilitation in post-CABG patients accelerates the healing process. In the past, phase 1 includes cardiopulmonary rehabilitation. In the recent years, musculoskeletal rehabilitation is one of the important part after CABG. Muscle energy technique is used to increase muscle extensibility. Different studies show favourable results of static stretching in increasing length of muscles and also of muscle energy technique in increasing length and strength of muscles. There is less evidence on increasing calf muscle flexibility in post-CABG patients. So this study will investigate the technique effective for increasing calf muscle extensibility in post-CABG patients.
This study will be conduced in Armed Forces Institute of Cardiology & National Institute of Heart Diseases(AFIC & NIHD) using non-probability purposive sampling technique. Sample size has been calculated from open epi tool is 135, 45 in each group. Patients are selected according to the inclusion criteria. Patients will be guided about the risks and benefits of the study, voluntary participation and confidentiality of the data. After taking informed consent patients will be randomly assigned to the groups using sealed envelope method. Length of the calf muscles and lower limb tempertaure will be measured before and immediately after the treatment. Post-isometric relaxation technique is given to one group, static stretching to the second group and basic cardiac rehabilitation protocol to the third group.
Group 1(Experimental group): post-isometric relaxation technique using 20% of strength, contraction time of 10 second with 15 second rest period in between+ 4 repetitions. Leg slides and ankle pumps, 2 sets of 10 repetitions. Walk for 10 minutes.
Group 2(Experimental group): static stretching 15 second hold time for stretch + 5 repetitions. Ankle pumps and leg slides: 2 sets of 10 repetitions. Walk for 10 minutes.
Group 3(Control Group): Ankle pumps and leg slides: 2 sets of 10 repetitions. Walk for 10 minutes.
Psot-isometric relaxation technique: This technique will be performed by asking the patient to contract his calf muscles using 20% of the strength. Maintain the contraction for 10 second with 15 second of rest period in between each contraction in which muscle is being lengthened. A total of 4 repetitions will be performed.
Static stretching: This technique will be performed by asking the patient to perform dorsiflexion till the point of discomfort. The patient will maintain the stretch for 15 second and 5 repetitions will be performed.
Length of calf muscles and temperature of lower limb will be measured immediately after the treatment.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Armed Forces Institute of Cardiology and National Institute of Heart Diseases
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- Age 35-75 years
- Both males and females
- Post-CABG patients with saphenous vein grafting
- Post-op day 4 with no post-op complications
Exclusion criteria
- Patient with DVT/Pulmonary Embolism, fever, infection at wound site
- Patient with psychosis, osteoporosis, vascular disease
- Hemodynamically unstable patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Basic Cardiac Rehabilitation protocol
ankle pumps and leg slides, 2 sets of 10 repetitions of each exercise.
Walk for 10 minutes.
|
Ankle pumps, leg slides, walking
|
|
EXPERIMENTAL: post-isometric relaxation technique with basic cardiac protocol
ankle pumps and leg slides, 2 sets of 10 repetitions of each exercise.
Walk for 10 minutes.
Post-isometric relaxation technique: contraction time 10 second using 20% of strength with 15 second rest period in between contractions + 4 repetitions.
|
Ankle pumps, leg slides, walking
Post-isometric relaxation technique will be performed by asking the patient to contract his calf muscles using 20% of his strength.
Maintain the contraction for 10 second with 15 second of rest time between each contractions.
A total of 4 contractions will be performed.
|
|
EXPERIMENTAL: static stretching with basic cardiac protocol
Ankle pumps and leg slides, 2 sets of 10 repetitions of each exercise.
Walk for 10 minutes.
Static stretching: 5 repetitions with 15 sec hold time of stretch.
|
Ankle pumps, leg slides, walking
Static stretching will be performed by asking patient to perform dorsiflexion till the point of discomfort.
The patient will hold the stretch for 15 second and 5 repetitions will be performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
length of calf muscles
Time Frame: Immediate after treatment
|
The length of soleus and gastrocnemius will be measured by using goniometer.
The participant will be in supine position with knee extended and knee flexed to 45 degrees for gastrocnemius and soleus muscle respectively.
The axis of the goniometer will be placed on lateral malleolus, moving arm parallel to the fifth metatarsal and stationary arm parallel to lower leg.
The patient is asked to perform dorsiflexion and the length is measured by recording the angle of the goniometer.
|
Immediate after treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Lower limb temperature
Time Frame: Immediate after treatment
|
Immediate after treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FUI/CTR/2022/13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Bypass
-
Queen Mary University of LondonRecruitingCoronary Artery Bypass | CABG | Valve Surgery | Coronary Artery Bypass Graft | Cardiovascular | Valve Replacement | Coronary Artery Bypass Graft Surgery (CABG)United Kingdom
-
Cairo UniversityEnrolling by invitationCoronary Artery Bypass Grafting | Post Coronary Artery Bypass GraftingEgypt
-
University of EdinburghNHS LothianRecruitingCoronary Artery Bypass | Coronary Artery Bypass Graft | Graft Failure | Coronary Artery Bypass Graft Surgery (CABG)United Kingdom
-
Infirmerie Protestante de LyonRecruitingCoronary Artery Bypass | Coronary Artery Disease(CAD) | Off Pump Coronary Artery Bypass Surgery | Hemodynamic Optimization | Hemodynamic Management | Off Pump Coronary Artery Bypass Graft | Coronary Artery Disease With Need for Bypass Surgery | NoradrenalineFrance
-
Nanjing First Hospital, Nanjing Medical UniversityCompletedCardiopulmonary Bypass | Coronary Artery Bypass GraftingChina
-
Peking University Third HospitalRecruitingCoronary Artery Bypass Grafting | Off-pump Coronary Artery Bypass | Minimally Invasive Cardiac Surgery | Coronary Arterial Disease (CAD)China
-
Cardiochirurgia E.H.Completed
-
Medistim ASACompletedRegistry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery (REQUEST)Coronary Artery BypassUnited States, United Kingdom, Netherlands, Canada, Germany, Italy
-
Maastricht University Medical CenterDutch Health Care Insurance Board (nr: 00106), Amstelveen, The NetherlandsCompleted
-
Federal University of UberlandiaCompletedCoronary Artery Bypass
Clinical Trials on Basic Cardiac Rehabilitation Protocol
-
Centre Hospitalier Universitaire de Saint EtienneCompletedMyocardial Infarction | Coronary Artery DiseaseFrance
-
Riphah International UniversityNot yet recruitingPost-cardiac Surgery PatientsPakistan
-
Good Shepherd Integrated Healthcare SystemsCompletedCardiac Surgery | Valve Replacement | Stent | Coronary Artery Bypass Graft CABGUnited States
-
Boston Medical CenterEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedLow Income Families Basic Social NeedsUnited States
-
Atlas UniversityCompletedCoronary Artery Disease | Coronary Artery Bypass Graft SurgeryTurkey (Türkiye)
-
Tampere University HospitalPihlajalinna Hospital, TampereNot yet recruitingRehabilitation | Patella Alta | Tibial Tubercle Distalisation Osteotomy
-
Manchester University NHS Foundation TrustActive, not recruitingRotator Cuff Tear | Rotator Cuff Tear or Rupture, Not Specified as TraumaticUnited Kingdom
-
Wake Forest University Health SciencesRecruitingCardiac AmyloidosisUnited States
-
Lawson Health Research InstituteHeart and Stroke Foundation of OntarioCompleted
-
Lawson Health Research InstituteCanadian Institutes of Health Research (CIHR); AstraZenecaCompletedMyocardial Infarction | Coronary Disease | Unstable AnginaCanada