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

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Basic Cardiac Rehabilitation protocol
ankle pumps and leg slides, 2 sets of 10 repetitions of each exercise. Walk for 10 minutes.
Procedure: Basic Cardiac Rehabilitation Protocol
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.
Procedure: Basic Cardiac Rehabilitation Protocol
Ankle pumps, leg slides, walking
Procedure: post-isometric relaxation technique
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.
Procedure: Basic Cardiac Rehabilitation Protocol
Ankle pumps, leg slides, walking
Procedure: Static stretching
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation University Islamabad

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Coronary Artery Bypass

Clinical Trials on Basic Cardiac Rehabilitation Protocol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings