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

Percutaneous CORONARY INTERVENTION Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06460571
• Other study ID #: REC/RCR&AHS/23/0365
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: IQBAL TARIQ, PHD
• Phone: 03338236752
• Email: iqbal.tariq[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: July 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Percutaneous CORONARY INTERVENTION

Intervention

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).
• 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

Locations

Country	Name	City	State
Pakistan	Bethania Hospital,	Sialkot	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QUALITY OF LIFE SCALE:	"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
Primary	MODIFIED BORG DYSPNEA SCALE	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
Primary	SETTLE ANGINA QUESTIONNAIRE	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