- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06460571
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
Recruiting
Conditions
Intervention / Treatment
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
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: iqbal Tariq, phd
- Phone Number: 03338236752
- Email: iqbal.tariq@riphah.edu.pk
Study Locations
-
-
Punjab
-
Sialkot, Punjab, Pakistan, 51040
- Recruiting
- Bethania Hospital,
-
Contact:
- Sidra Afzal, PP-DPT
- Phone Number: 03124378540
- Email: sidra.afzal@riphah.edu.pk
-
-
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.
Sponsor
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.
General Publications
- Fish DE, Krabak BJ, Johnson-Greene D, DeLateur BJ. Optimal resistance training: comparison of DeLorme with Oxford techniques. Am J Phys Med Rehabil. 2003 Dec;82(12):903-9. doi: 10.1097/01.PHM.0000098505.57264.DB.
- Jelinek HF, Huang ZQ, Khandoker AH, Chang D, Kiat H. Cardiac rehabilitation outcomes following a 6-week program of PCI and CABG Patients. Front Physiol. 2013 Oct 30;4:302. doi: 10.3389/fphys.2013.00302. eCollection 2013.
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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