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Power Walking On Quality Of Life In Post CABG Patient Undergoing Phase 2 Cardiac Rehabilitation

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Power Walking
Standardized Outpatient Cardiac Rehabilitation
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and Female subject Age will be from 50 to 70 Four weeks after CABG surgery patient are eligible to participate Patient able to walk on Treadmill with Cardiac symptoms stable or absent Appropriate HR response to exercise Exclusion Criteria: Those patients with contraindications to exercise or clinical risk factors, such as musculoskeletal, neurological, pulmonary or metabolic disorder were all excluded from the study.

Sites / Locations

  • Women Institute of Rehabilitation Sciences (WIRS) and Jinnah International Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Power Walking

Standardized Outpatient Cardiac Rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

Heart Quality of Life questionnaire
Changes from baseline to 4 week, The 14 items in the HeartQoL scale form a bi-dimensional questionnaire with a 10-item HeartQoL physical subscale and a 4-item HeartQoL emotional subscale that provides a global assessment and evaluation of how much a patient with angina, MI, or heart fail.

Secondary Outcome Measures

Six Minute Walk Test (6MWT)
Changes from baseline to 4 week, The 6MWT can be used in preschool children (2-5 years), children (6-12 years) adults (18-64 years), elderly adults (65+) with a wide range of diagnoses including. The test was initially designed to help in the assessment of patient with cardiopulmonary is
BORG Rating of Perceived exertion
Changes from baseline to 4 week, The Borg RPE Scale is a 15-point scale (6 to 20) used to rate subjective experiences during physical exertion. This subjective load scale can help estimate load symptoms, such as the degree of exertion, the degree of load and fatigue. The Borg scale among
Pulse rate
Changes from baseline to 4 week, Pulse rate will be measured through the Pulse Oximeter in beats per min before and after the exercise for the patient safety during exercise
Liebowitz Social Anxiety Scale
Changes from baseline to 4 week, The LSAS is a 24-item scale that assesses fear of social situations and avoidance throughout the previous week. It includes 11 things that deal with social contact and 13 ones that deal with public performance. A physician rates each item on two 4-point L

Full Information

First Posted
January 22, 2023
Last Updated
July 7, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05706961
Brief Title
Power Walking On Quality Of Life In Post CABG Patient Undergoing Phase 2 Cardiac Rehabilitation
Official Title
Effect Of Power Walking On Quality Of Life In Post CABG Patient Undergoing Phase 2 Cardiac Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the effect of power walking on quality of life in Post CABG population undergoing phase 2 cardiac rehabilitation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Power Walking
Arm Type
Experimental
Arm Title
Standardized Outpatient Cardiac Rehabilitation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Power Walking
Intervention Description
For 1- 2 Week 60% of the target heart rate with 5,000 to 7,500 steps/day Total 30 min Session The exercise intensity was set at 60% of the target heart rate during the first 2 weeks. For 3- 4 week 70 % of the target heart rate with 7,500 to 10,000 steps/day Total 30 min Session B) Progressive increase walk according to 6MWD as improved Low intensity
Intervention Type
Other
Intervention Name(s)
Standardized Outpatient Cardiac Rehabilitation
Intervention Description
For 1- 2 week Standardized Outpatient Cardiac Rehabilitation (includes warm up of 5 min, aerobic 60 % of of target heart rate, resistive ex with 1- 3 kg of weight for 20 min and 10 min of cool down) For 3 - 4 week Standardized Outpatient Cardiac Rehabilitation (includes warm up of 5 min, aerobic 70 % of target heart rate, resistive ex with 2- 3 kg of weight for 20 min and 10 min of cool down)
Primary Outcome Measure Information:
Title
Heart Quality of Life questionnaire
Description
Changes from baseline to 4 week, The 14 items in the HeartQoL scale form a bi-dimensional questionnaire with a 10-item HeartQoL physical subscale and a 4-item HeartQoL emotional subscale that provides a global assessment and evaluation of how much a patient with angina, MI, or heart fail.
Time Frame
4th weeks
Secondary Outcome Measure Information:
Title
Six Minute Walk Test (6MWT)
Description
Changes from baseline to 4 week, The 6MWT can be used in preschool children (2-5 years), children (6-12 years) adults (18-64 years), elderly adults (65+) with a wide range of diagnoses including. The test was initially designed to help in the assessment of patient with cardiopulmonary is
Time Frame
4th week
Title
BORG Rating of Perceived exertion
Description
Changes from baseline to 4 week, The Borg RPE Scale is a 15-point scale (6 to 20) used to rate subjective experiences during physical exertion. This subjective load scale can help estimate load symptoms, such as the degree of exertion, the degree of load and fatigue. The Borg scale among
Time Frame
4th Week
Title
Pulse rate
Description
Changes from baseline to 4 week, Pulse rate will be measured through the Pulse Oximeter in beats per min before and after the exercise for the patient safety during exercise
Time Frame
4th Week
Title
Liebowitz Social Anxiety Scale
Description
Changes from baseline to 4 week, The LSAS is a 24-item scale that assesses fear of social situations and avoidance throughout the previous week. It includes 11 things that deal with social contact and 13 ones that deal with public performance. A physician rates each item on two 4-point L
Time Frame
4th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and Female subject Age will be from 50 to 70 Four weeks after CABG surgery patient are eligible to participate Patient able to walk on Treadmill with Cardiac symptoms stable or absent Appropriate HR response to exercise Exclusion Criteria: Those patients with contraindications to exercise or clinical risk factors, such as musculoskeletal, neurological, pulmonary or metabolic disorder were all excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women Institute of Rehabilitation Sciences (WIRS) and Jinnah International Hospital
City
Abbottābād
State/Province
Khyber PkahtoonKhwa
ZIP/Postal Code
22010
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Power Walking On Quality Of Life In Post CABG Patient Undergoing Phase 2 Cardiac Rehabilitation

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