Cardiac Rehabilitation With and Without Delorme Technique of Progressive Resisted Exercises in Patients of Post PCI.

June 11, 2024 updated by: Riphah International University

The Effect of Cardiac Rehabilitation With and Without Delorme Technique of Progressive Resisted Exercises to Improve Dyspnea and Quality of Life in Patients of Post PCI.

To find the effect of cardiac rehabilitation program with and without progressive resisted exercises on patients after acute stage of PCI with at least 8 weeks history. It is a randomized clinical trial using convenient sampling technique. Randomly assign participants into two groups: An intervention group receiving Delorme progressive resisted exercise along with cardiac rehab and a control group undergoing standard cardiac rehabilitation alone. In Group A, Delorme technique will involve a 10-repetition max of aerobic and resistance exercises along with cardiac rehab. Seven different exercises will be performed in 3 sets of 10-repetition max. The control group will not be performing any type of training but will undergo cardiac rehab alone. Data will be analyzed using t test and SPSS 21 will be used for data collection. Age group will be from ≥70 years with patient undergoing dyspnea along with recent history of primary diseases. Data will be collected from Bethania Hospital, Sialkot through tools like the 6-minute walk test, Rose Angina questionnaire or settle angina questionnaire, quality of life scale (QOLFS), and Modified Borg dyspnea scale.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

52

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 Contact

Study Contact Backup

Study Locations

    • Punjab
      • Sialkot, Punjab, Pakistan, 51040

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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: ≥ 70 years"
  • "Recent history of PCI due to primary diseases (coronary heart disease, acute myocardial infarction, acute coronary syndrome, acute angina)"
  • "Presence of dyspnea"
  • "First-time PCI

Exclusion Criteria:

  • "Renal failure"
  • Chronic liver disease
  • Chest disease
  • Patient who could not fulfill the questionnaire or cooperate through the performed procedures

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Cardiac rehabilitation with Delorme technique
The intervention group will receive Delorme technique along with standard cardiac rehabilitation, involving 10 repetition max of aerobic exercises, resistance exercises of 10 minutes will be given in each training session
Aerobic training will be provided three alternate days a week at 60-70% of maximum heart rate for eight weeks. Resistance training for 3 sets and 10 repetitions (10 lifts with 50%of 10RM, then 75% of 10RM and will progress to 100% of 10RM) will involve seven exercises (abdominal curl ups, bicep curls, triceps extension, back extension, leg curls, side leg raises and knee extensions).
The control group (Group B) will undergo standard cardiac rehabilitation (outpatient cardiac rehabilitation) which include walking, cycling and strength training which will have 5-10 minutes warm-up followed by training for 30-45 minutes, concluding with cool-down without the Delorme technique. The control group will not perform any specific training but will be given a diet chart to follow
Active Comparator: standard cardiac rehabilitation
The control group (Group B) will undergo standard cardiac rehabilitation (outpatient cardiac rehabilitation) which include walking, cycling and strength training which will have 5-10 minutes warm-up followed by training for 30-45 minutes, concluding with cool-down without the Delorme technique.
The control group (Group B) will undergo standard cardiac rehabilitation (outpatient cardiac rehabilitation) which include walking, cycling and strength training which will have 5-10 minutes warm-up followed by training for 30-45 minutes, concluding with cool-down without the Delorme technique. The control group will not perform any specific training but will be given a diet chart to follow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QUALITY OF LIFE SCALE:
Time Frame: baseline and fourth week
"The QOLS was originally a 15-item instrument that measured five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation
baseline and fourth week
MODIFIED BORG DYSPNEA SCALE
Time Frame: baseline and fourth week
The Modified Borg Dyspnea Scale (MBS) is a numerical rating system (0-10) assessing dyspnea during submaximal exercise. Administered with the six-minute walk test (6MWT), a common measure for pulmonary arterial hypertension (PAH), the MBS is consistent within a single session
baseline and fourth week
SETTLE ANGINA QUESTIONNAIRE
Time Frame: baseline and fourth week
Settle Angina Questionnaire (SAQ) scale is a disease specific scale is a diabetes specific scale for assessing QOL of CHD patients; have 5 items covering domains; Physical Limitation, Angina Stability, Angina Severity, Treatment Satisfaction and Disease Perception
baseline and fourth week

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sidra Afzal, PP-DPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)

January 15, 2024

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

July 15, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • REC/RCR&AHS/23/0365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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