Exercise Training in Coronary Artery Disease Patients After Stenting

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05591365
Collaborator
(none)
16
1
2
5.4
3

Study Details

Study Description

Brief Summary

To determine the effect of exercise training on cardiac outcomes in coronary artery disease patients after Stenting. There is a need to develop strategies, not only to prevent restenosis but also to improve patients' functional status and perception of well-being. In particular, it is not well defined whether exercise training can reduce the restenosis rate and improve the outcome after PCI.

Condition or Disease Intervention/Treatment Phase
  • Other: Structured In-Patient and Home plan
  • Other: Conventional Therapy
N/A

Detailed Description

Based on an analysis of literature reviews, psychological symptoms (such as depression and anxiety), angina, vital exhaustion, and dyspnea have been observed to have the most significant influence on the quality of life in people with CAD. Almost half of the patients, after an initial encouraging improvement in functional capacity and quality of life (QOL) after the PCI, deal with recurrent chest pain that requires medical attention, reduces functional capacity, and creates a status of psychological distress.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effects of Exercise Training on Cardiac Parameters in Coronary Artery Disease Patients After Stenting
Actual Study Start Date :
Oct 18, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Structured In-patient and Home plan

Structured In-patient and Home plan

Other: Structured In-Patient and Home plan
A patient education session and a protocol comprise of 3 days. It consists of three different levels having progressive activities. The in-patient protocol will start from the day of the procedure. Each level contains 2 to 6 tasks, performed in sets of 5-10 repetitions 3 times a day. Home plan: Walking 3 days a week starting from normal pace ((RPE: 8-9) for10 minutes and progressively increased intensity and duration over the period of 12 weeks (RPE: 13-14).

Placebo Comparator: Conventional therapy

Conventional protocol as per guidelines

Other: Conventional Therapy
In-Patient: Wound care, Bed mobility: AROMS (10 Reps*3sets*TD), Breathing Exercise (10 Reps*3sets*TD), Mobilization (Walk as per patient tolerance) Patient Education: To keep the heart healthy Diet Avoid strenuous exercise and lifting heavy objects Avoid valsalva manure, Quit smoking Lower cholesterol levels, Maintain a healthy weight Control other conditions, such as diabetes and high blood pressure Take medications as prescribed by your doctor Get regular exercise: Walking at a normal pace as per tolerance (RPE up to 10)

Outcome Measures

Primary Outcome Measures

  1. 6 min walk test: Distance (meters) [12 weeks]

    Changes from the baseline,6th week and 12th week, 6 min walk test (6 MWT) was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.

  2. Mindfulness [12 weeks]

    Changes from the Baseline,6th week and 12th week, measured through MAAS. The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present. The scale shows strong psychometric properties and has been validated with college, community, and cancer patient samples.Higher scores reflect higher levels of dispositional mindfulness

  3. Rate of perceived exertion (RPE) [12 weeks]

    Changes from the Baseline,6th week and 12th week, measured through Borg RPE scale which measures a person's perception of their effort and exertion breathlessness, and fatigue during physical work rating between 6 and 20. The higher the number, the more intense the exercise. An RPE of 6 is often referred to as just above rest, hardly any exertion, while an RPE of 20 is a maximal effort.

  4. Dyspnea [12 weeks]

    Changes From the Baseline,6th week and 12th week, measured through Rose Dyspnea Scale. The scale consists of four items, with scores ranging from 0 to 4, where 0 indicates no dyspnea with activity, and increasing scores indicate greater limitations because of dyspnea.

  5. Mean arterial pressure [3-5 days]

    Changes From the Baseline, measured through cardiac monitor. Normal range is between 70 and 100 mm Hg.

  6. Heart Rate [3-5 days]

    Changes From the Baseline, measured through Cardiac monitor/Pulse-oximeter. Normal Resting Heart rate ranges from 60 to 100 beats per minute.

  7. Respiratory rate [3-5 days]

    Changes From the Baseline, measured through cardiac monitor. Normal Resting Respiratory rate is12 to 20 breaths per minute

  8. Transcutaneous oxygen saturation [SpO2] [3-5 days]

    Changes From the Baseline, measured through Cardiac monitor/Pulse-oximeter. Normal Resting SpO2 ranges 95% or higher.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • GCS = 15

  • Disease chronicity: 1-3 years

  • Elective / stenting procedure

  • Single or Double vessel stunting

  • EF: 35 above

Exclusion Criteria:
  • Unwilling to participate in research

  • Known cases of Uncontrolled DM or HTN

  • Known cases of Cognitive/memory/neurological disorders

  • Known cases of any Systemic disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Armed forces institute of cardiology Rawalpindi Punjab Pakistan 4400

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Mehwish Waseem, MSPT(CPPT), Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05591365
Other Study ID Numbers:
  • Rec/01277 Pakiza Batool
First Posted:
Oct 24, 2022
Last Update Posted:
Oct 24, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 24, 2022