Percutaneous CORONARY INTERVENTIONNCT06460571
Cardiac Rehabilitation With and Without Delorme Technique of Progressive Resisted Exercises in Patients of Post PCI.
A study testing Standard Cardiac rehabilitation with Delorme technique and standard cardiac rehabilitation in people with Percutaneous CORONARY INTERVENTION, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 70 to 80 years
- Conditions the study is for
- Percutaneous CORONARY INTERVENTION
- What is being tested?
- Standard Cardiac rehabilitation with Delorme technique and standard cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2024to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- "Renal failure"
- Chronic liver disease
- Chest disease
- Patient who could not fulfill the questionnaire or cooperate through the performed procedures
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Bethania Hospital,
Sialkot, Punjab Province, 51040
Sidra Afzal, PP-DPT, 03124378540, sidra.afzal@riphah.edu.pk
About this study
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.
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.
- Conditions
- Percutaneous CORONARY INTERVENTION
- Being tested
- Standard Cardiac rehabilitation with Delorme technique, standard cardiac rehabilitation
- Keywords
- Quality of Life, Cardiac Rehabilitation, Delorme Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Cardiac rehabilitation with Delorme techniqueOther
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 rehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard Cardiac rehabilitation with Delorme technique | Experimental | 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 Receives: Other: Standard Cardiac rehabilitation with Delorme technique; Other: standard cardiac rehabilitation |
| standard cardiac rehabilitation | Active comparator | 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. Receives: Other: standard cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and fourth week
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
Measured: baseline and fourth week
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
Measured: baseline and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start15 Jan 2024
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Percutaneous CORONARY INTERVENTIONStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Afzal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460571
- Sponsor's protocol ID
- REC/RCR&AHS/23/0365
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 14627926Jelinek 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.
PubMed 24198786
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06460571
- Acronym / sponsor ID
- REC/RCR&AHS/23/0365
- Conditions
- Percutaneous CORONARY INTERVENTION
- Keywords
- Quality of Life, Cardiac Rehabilitation, Delorme Technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Cardiac rehabilitation with Delorme technique | Experimental | Other: Standard Cardiac rehabilitation with Delorme technique, Other: standard cardiac rehabilitationThe 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 |
| standard cardiac rehabilitation | Active comparator | Other: standard cardiac rehabilitationThe 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. |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- "Renal failure"
- Chronic liver disease
- Chest disease
- Patient who could not fulfill the questionnaire or cooperate through the performed procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Cardiac rehabilitation with Delorme techniqueAerobic 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 with Delorme technique |
| standard cardiac rehabilitationThe 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 | Other | Standard Cardiac rehabilitation with Delorme technique, standard cardiac rehabilitation |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 14627926Fish 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.
- Background: PubMed 24198786Jelinek 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.
- Individual participant dataSharing planned: No
Related trials for Percutaneous CORONARY INTERVENTION
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RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
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RecruitingPhase 3
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidra Afzal, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Cardiac rehabilitation with Delorme technique and standard cardiac rehabilitation in people with Percutaneous CORONARY INTERVENTION, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IQBAL TARIQ, PHD (03338236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QUALITY OF LIFE SCALE: (time frame: baseline and fourth week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460571, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.