NCT05503537

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

August 14, 2022

Last Update Submit

August 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediate after treatment

Secondary Outcomes (1)

  • Lower limb temperature

    Immediate after treatment

Study Arms (3)

Basic Cardiac Rehabilitation protocol

ACTIVE COMPARATOR

ankle pumps and leg slides, 2 sets of 10 repetitions of each exercise. Walk for 10 minutes.

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.

Procedure: post-isometric relaxation techniqueProcedure: 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.

Procedure: Static stretchingProcedure: Basic Cardiac Rehabilitation Protocol

Interventions

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.

post-isometric relaxation technique with basic cardiac protocol

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.

static stretching with basic cardiac protocol

Ankle pumps, leg slides, walking

Basic Cardiac Rehabilitation protocolpost-isometric relaxation technique with basic cardiac protocolstatic stretching with basic cardiac protocol

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 35-75 years
  • Both males and females
  • Post-CABG patients with saphenous vein grafting
  • Post-op day 4 with no post-op complications

You may not qualify if:

  • Patient with DVT/Pulmonary Embolism, fever, infection at wound site
  • Patient with psychosis, osteoporosis, vascular disease
  • Hemodynamically unstable patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Institute of Cardiology and National Institute of Heart Diseases

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor does not know that the participant receives which treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2022

First Posted

August 16, 2022

Study Start

August 1, 2022

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations