Effect of Post-isometric Relaxation Technique and Static Stretching on Length of the Calf Muscles in Post-CABG Patients

August 14, 2022 updated by: Foundation University Islamabad
Coronary artery bypass grafting (CABG) is one of the common procedure used in coronary artery disease patients which has significant impact on cardiopulmonary and musculoskeletal systems. In the past, phase 1 rehabilitation after procedure focus on cardiopulmonary system. Lower limb rehabilitation is also important part as it influence the cardiac function. Several studies work on post-CABG patients to improve cardiopulmonary fitness but there is less number of data on calf muscles rehabilitation in post-CABG patients. So this study aims to increase the calf muscle extensibility using post-isometric relaxation technique and static stretching.

Study Overview

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

Interventional

Enrollment (Anticipated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Armed Forces Institute of Cardiology and National Institute of Heart Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2022

Primary Completion (ANTICIPATED)

January 1, 2023

Study Completion (ANTICIPATED)

February 1, 2023

Study Registration Dates

First Submitted

August 14, 2022

First Submitted That Met QC Criteria

August 14, 2022

First Posted (ACTUAL)

August 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 14, 2022

Last Verified

August 1, 2022

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

No

Studies a U.S. FDA-regulated device product

No

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.

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