NCT06460571

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

June 11, 2024

Last Update Submit

June 11, 2024

Conditions

Keywords

Quality of LifeCardiac RehabilitationDelorme Technique

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

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

Other: Standard Cardiac rehabilitation with Delorme techniqueOther: 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.

Other: standard cardiac rehabilitation

Interventions

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 with 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

Standard Cardiac rehabilitation with Delorme techniquestandard cardiac rehabilitation

Eligibility Criteria

Age70 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bethania Hospital,

Sialkot, Punjab Province, 51040, Pakistan

RECRUITING

Related 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.

    PMID: 14627926BACKGROUND
  • 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.

    PMID: 24198786BACKGROUND

Study Officials

  • Sidra Afzal, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

January 15, 2024

Primary Completion

June 15, 2024

Study Completion

July 15, 2024

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations