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

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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 (Estimated)

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.
52

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • 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

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

  • 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

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.
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
Other: Standard Cardiac rehabilitation with Delorme technique
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).
Other: 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 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.
Other: 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 will not perform any specific training but will be given a diet chart to follow

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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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.
January 15, 2024

Primary Completion (Estimated)

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.
June 15, 2024

Study Completion (Estimated)

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.
July 15, 2024

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).
June 11, 2024

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.
June 11, 2024

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.
June 14, 2024

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.
June 14, 2024

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.
June 11, 2024

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.
June 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 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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