Coronary Artery BypassNCT05503537
Effect of Post-isometric Relaxation Technique and Static Stretching on Length of the Calf Muscles in Post-CABG Patients
A study testing post-isometric relaxation technique, Static stretching and Basic Cardiac Rehabilitation Protocol in people with Coronary Artery Bypass, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Coronary Artery Bypass
- What is being tested?
- post-isometric relaxation technique, Static stretching and Basic Cardiac Rehabilitation Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 35-75 years
- Both males and females
- Post-CABG patients with saphenous vein grafting
- Post-op day 4 with no post-op complications
Who cannot join
- Patient with DVT/Pulmonary Embolism, fever, infection at wound site
- Patient with psychosis, osteoporosis, vascular disease
- Hemodynamically unstable patients
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute of Cardiology and National Institute of Heart Diseases
Rawalpindi, Punjab Province, 46000
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Bypass
- Being tested
- post-isometric relaxation technique, Static stretching, Basic Cardiac Rehabilitation Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-isometric relaxation techniqueProcedure or surgery
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.
Static stretchingProcedure or surgery
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.
Basic Cardiac Rehabilitation ProtocolProcedure or surgery
Ankle pumps, leg slides, walking
| Study group | Role | What they receive |
|---|---|---|
| Basic Cardiac Rehabilitation protocol | Active comparator | ankle pumps and leg slides, 2 sets of 10 repetitions of each exercise. Walk for 10 minutes. Receives: Procedure: Basic Cardiac Rehabilitation Protocol |
| post-isometric relaxation technique with basic cardiac protocol | Experimental | 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. Receives: Procedure: post-isometric relaxation technique; Procedure: Basic Cardiac Rehabilitation Protocol |
| static stretching with basic cardiac protocol | Experimental | 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. Receives: Procedure: Static stretching; Procedure: Basic Cardiac Rehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of calf muscles
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.
Measured: Immediate after treatment
Secondary outcomes (1)
Lower limb temperature
Measured: Immediate after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Aug 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is randomized controlled trial which consist of three group. One group will be given generalized cardiac rehabilitation protocol. Second group will be given post-isometric relaxation technique along with generalized cardiac protocol and third group will be given static stretching along with generalized cardiac protocol. All the groups will be recruited concurrently.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503537
- Sponsor's protocol ID
- FUI/CTR/2022/13
- Status last verified
- Aug 2022
- First submitted
- 14 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Post-isometric Relaxation Technique and Static Stretching on Length of the Calf Muscles in Post-CABG Patients
- ClinicalTrials.gov ID
- NCT05503537
- Acronym / sponsor ID
- FUI/CTR/2022/13
- Conditions
- Coronary Artery Bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study is randomized controlled trial which consist of three group. One group will be given generalized cardiac rehabilitation protocol. Second group will be given post-isometric relaxation technique along with generalized cardiac protocol and third group will be given static stretching along with generalized cardiac protocol. All the groups will be recruited concurrently.
| Arm | Type | Receives |
|---|---|---|
| Basic Cardiac Rehabilitation protocol | Active comparator | Procedure: Basic Cardiac Rehabilitation Protocolankle pumps and leg slides, 2 sets of 10 repetitions of each exercise. Walk for 10 minutes. |
| post-isometric relaxation technique with basic cardiac protocol | Experimental | Procedure: post-isometric relaxation technique, Procedure: Basic Cardiac Rehabilitation Protocolankle 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. |
| static stretching with basic cardiac protocol | Experimental | Procedure: Static stretching, Procedure: Basic Cardiac Rehabilitation ProtocolAnkle 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 35-75 years
- Both males and females
- Post-CABG patients with saphenous vein grafting
- Post-op day 4 with no post-op complications
Key exclusion criteria (3 listed)
- Patient with DVT/Pulmonary Embolism, fever, infection at wound site
- Patient with psychosis, osteoporosis, vascular disease
- Hemodynamically unstable patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| post-isometric relaxation techniquePost-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. | Procedure or surgery | post-isometric relaxation technique with basic cardiac protocol |
| Static stretchingStatic 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. | Procedure or surgery | static stretching with basic cardiac protocol |
| Basic Cardiac Rehabilitation ProtocolAnkle pumps, leg slides, walking | Procedure or surgery | Basic Cardiac Rehabilitation protocol, post-isometric relaxation technique with basic cardiac protocol, static stretching with basic cardiac protocol |
Primary outcome
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.
1 secondary outcome
Lower limb temperature
Time frame: Immediate after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing post-isometric relaxation technique, Static stretching and Basic Cardiac Rehabilitation Protocol in people with Coronary Artery Bypass, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of calf muscles (time frame: Immediate after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.