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Tai Chi Exercises on Physical Activity and Pulmonary Function in CABG

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Aerobic Exercises
Tai Chi Exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Bicycling, Coronary Artery Disease, Pulmonary Function, Tai Chi

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • post-operative CABG patients,
  • Ejection fraction >40% were included

Exclusion Criteria:

  • 2,3,4 scale of angina,
  • unstable congestive heart failure,
  • Substantial myocardial ischemia,
  • Cardiac arrhythmias,
  • Reopen chest after surgery,
  • Uncontrolled diabetes and hypertension

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aerobic Exercises

Tai Chi Exercises

Arm Description

Bicycling Exercise (lower Limb)

Tai Chi Exercises (yang 24 Postures)

Outcomes

Primary Outcome Measures

forced expiratory volume in one second (FEV1)
Changes from the Baseline, forced expiratory volume in one second (FEV1) in liters will be measured through Digital spirometer
Forced vital capacity (FVC)
Changes from the Baseline, forced vital capacity (FVC) in liters will be measured through Digital spirometer
Peak expiratory flow (PEF).
Changes from the Baseline, Peak expiratory flow (PEF) in Liters/seconds will be measured through Digital spirometer
International physical activity questionnaire (IPAQ)
Changes from Baseline, (IPAQ) It is recommended that activity bouts of greater than 3 hours are truncated. That is to say that a bout cannot be longer than 3 hours (180 minutes). This means that in each category a maximum of 21 hours of activity are permitted a week (3 hours X 7 days) To calculate metabolic equivalent (MET) minutes a week multiply the MET value given (remember walking = 3.3, moderate activity = 4, vigorous activity = 8) by the minutes the activity was carried out and again by the number of days that that activity was undertaken. For example if someone reports walking for 30 minutes 5 days a week then the total MET minutes for that activity are 3.3 X 30 X 5=495 Met minutes a week. You can add the MET minutes achieved in each category (walking, moderate activity and vigorous activity) to get total MET minutes of physical activity a week.

Secondary Outcome Measures

Modified Borg's rating of perceived exertion (RPE) scale
(RPE) Scale - Modified BORG scale. Grading scale for fatigue and endurance. 0. At rest. 1. Very easy. 2. Somewhat easy. 3. Moderate. 4. Somewhat hard. 5. Hard 7 very Hard and 10 very, very hard
Heart Rate
Changes from the Baseline; Heart Rate (beats per minute)
Oxygen Saturation (SPO2)
Changes from the Baseline; Saturation in Percentage
Blood Pressure
Changes from the Baseline; Blood Pressure in (mmHg)
Heart Rate Reserve
Changes from the Baseline; Heart Rate Reserve beat per minute
Respiratory Rate
Changes from the Baseline; Respiratory Rate breath per minute

Full Information

First Posted
February 8, 2019
Last Updated
August 7, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT03857282
Brief Title
Tai Chi Exercises on Physical Activity and Pulmonary Function in CABG
Official Title
The Effect of Tai Chi Exercises on Physical Activity and Pulmonary Function In Patients With Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
July 5, 2018 (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 improve the cardiopulmonary endurance in Coronary artery bypass grafting (CABG) patients. Internationally in cardiac hospital facility of cardiac rehabilitation is available to improve the patient's physical activity and decrease the list of secondary complications. But in Pakistan ideal phase II cardiac rehabilitation is limited available in limited hospitals due to cost issues and limited resources for monitoring during exercise. A Randomized control trail Study was conducted in Armed force institute of cardiology (AFIC) Rawalpindi. The Total sample size was 74 post (CABG). The aim of study was to influence of Tai chai on coronary artery bypass surgery patients.
Detailed Description
Coronary blood vessel disease is a disease of vessels supplying the muscles of the heart. Heart attack is generally acute condition and mainly produced by an obstruction, that stop the blood supply to the heart. Coronary artery diseases can be progressive or non-progressive. Physical activity or exercise is necessary for all the healthy individuals to prevent the risk of diseases and maintained health status. Physical exercise often varies from physical activity by animation more measured in relations of intensity and period, while physical activity studies tend to integrate an enormous diversity of unspecified activities. Physical activity or exercise is used as conservative treatment of coronary artery diseases as a cardiac rehabilitation. Cardiac rehabilitation gives positive effect on patient's conditions by the exercise training program. Exercise may improve the maximal oxygen consumption (VO2 max) and repetitive capacity or capability to maintain physical activity for long periods of time. Exercise have multiple benefits on improving endothelial function, myocardial stream replacement decreasing smoking, body mass, plasma fats and blood pressure. Guided work out or exercise may decrease the development of coronary atherosclerosis. Different types of Aerobic exercises are the part of cardiac rehabilitation, start at very early in patients with coronary artery bypass grafting. Aerobic exercises may improve the maintenance of functional capacity and muscular strength but it shows no impact on pulmonary function and respiratory muscle strength. Aerobic exercises are perform in different ways some of them are in the form of intervals and some are continues. Studies shows that Four weeks of intense training increased VO2 peak significantly after both aerobic interval training and moderate continues training, but After 6 months only aerobic interval training gives high peak oxygen uptake (VO2 peak). It shows that both training have similarly effects in the tiny tenure and in extensive tenure only effect aerobic interval training. The most common aerobic exercises are perform at Treadmill and bicycle in cardiac rehabilitation program. Studies shows that Treadmill aerobic working out progresses both functional mobility and circulatory appropriateness in patients with chronic (CABG) and is more operational than reference rehabilitation reciprocated to conventional care. Now a day Tai chi is used in all over the world for health and defense or protection. Tai chi is a fighting art it is used in defense and health related fitness it is appropriate conditioning exercise for elder people. In health related benefits Yang Tai chi are most commonly practiced worldwide. Tai chi exercises are also practiced in rehabilitation department to gain the balance, coordination, endurance and physical activity in patients with stroke and coronary artery bypass grafting most commonly. Consistent aerobic workout and lifestyle modification are imperative for preventing and treating high blood pressure. For individuals with hypertension ,The American College of Sports Medicine recommends the following exercise guidelines like frequency: aerobic exercise most preferably all days of a week; resistance exercise 2-3 days per week. Intensity of exercise must be moderate intensity aerobic and resistance exercise. Time of exercise must be 30-60 minutes for every day of aerobic implementation while resistance working out at least one set of 8-12 reiterations for each of the main muscle groups. Studies shows that Tai Chi gives positive effects on blood pressure. Tai Chi training may reduce the systolic and diastolic blood pressure in patients with HTN. Tai chi also reduce the systolic as well as diastolic in normal healthy individuals. Young DR, conducted a study with the title of "The properties of aerobic workout and Tai Chi on blood pressure in older individuals" and they concluded that the programs of low and modest concentration workout have the same effects on blood pressure in elderly patients. Stroke is a common root of expiry in ageing population it is due to atherosclerosis are hemorrhagic in the minor or intermediate vessels of the brain. In such kind of patient significant reduction in quality of life, neurological discrepancies and deficiency of intellectual function.It reported that stroke patients increasing peak oxygen acceptance and walking distance by workout. Cerebrovascular accident patients frequently have compromised equilibrium and motor function, thus Tai Chi training program can be used in rehabilitation of stroke. A study in elderly subjects on Tai chi, balancing exercise and workout instruction groups. After four months of physical activity the follow up evaluation illustrate that only Tai Chi subjects informed that their daily activities and their whole life had been exaggerated. The result demonstrates that in women emotional as well as physical control is supposed to be improved in sense of enhancement in overall well-being and inspiration to continue physical training also rises. Effectiveness of Tai Chi, brisk hiking, meditation and reading in reducing psychological and emotional stress in 1992 and calculated that Tai Chi activities are used to decrease mental stress or disorder it is advantageous to quit smoking, drinking and other life threatening obsessions also. For the reason that Tai Chi is also used as to enlarge psychological well being and mental sickness. Another study concluded that Tai Chi trainings are an aerobic movements it is very supportive for different age and gender, it also increase functional capability of the participants. There was a research gap in previous study Tai chi training was done after phase II cardiac rehabilitation and duration of training was 6 months to 1 year. In current study we analyze Effect of Tai chi exercise on physical activity, pulmonary function and the rate of perceived exertion after exercise in patients with cardiovascular bypass surgeries in phase II cardiac rehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Bicycling, Coronary Artery Disease, Pulmonary Function, Tai Chi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercises
Arm Type
Active Comparator
Arm Description
Bicycling Exercise (lower Limb)
Arm Title
Tai Chi Exercises
Arm Type
Experimental
Arm Description
Tai Chi Exercises (yang 24 Postures)
Intervention Type
Other
Intervention Name(s)
Aerobic Exercises
Intervention Description
5 to 10 min warm up exercises than 30min bicycle exercise and 5 to 10 min cool down exercises
Intervention Type
Other
Intervention Name(s)
Tai Chi Exercises
Intervention Description
5 to 10 min warm up exercises and 30 min Tai Chi exercises and than than 5 to 10 min cool down exercises.
Primary Outcome Measure Information:
Title
forced expiratory volume in one second (FEV1)
Description
Changes from the Baseline, forced expiratory volume in one second (FEV1) in liters will be measured through Digital spirometer
Time Frame
6 weeks
Title
Forced vital capacity (FVC)
Description
Changes from the Baseline, forced vital capacity (FVC) in liters will be measured through Digital spirometer
Time Frame
6 weeks
Title
Peak expiratory flow (PEF).
Description
Changes from the Baseline, Peak expiratory flow (PEF) in Liters/seconds will be measured through Digital spirometer
Time Frame
6 weeks
Title
International physical activity questionnaire (IPAQ)
Description
Changes from Baseline, (IPAQ) It is recommended that activity bouts of greater than 3 hours are truncated. That is to say that a bout cannot be longer than 3 hours (180 minutes). This means that in each category a maximum of 21 hours of activity are permitted a week (3 hours X 7 days) To calculate metabolic equivalent (MET) minutes a week multiply the MET value given (remember walking = 3.3, moderate activity = 4, vigorous activity = 8) by the minutes the activity was carried out and again by the number of days that that activity was undertaken. For example if someone reports walking for 30 minutes 5 days a week then the total MET minutes for that activity are 3.3 X 30 X 5=495 Met minutes a week. You can add the MET minutes achieved in each category (walking, moderate activity and vigorous activity) to get total MET minutes of physical activity a week.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Modified Borg's rating of perceived exertion (RPE) scale
Description
(RPE) Scale - Modified BORG scale. Grading scale for fatigue and endurance. 0. At rest. 1. Very easy. 2. Somewhat easy. 3. Moderate. 4. Somewhat hard. 5. Hard 7 very Hard and 10 very, very hard
Time Frame
6 weeks
Title
Heart Rate
Description
Changes from the Baseline; Heart Rate (beats per minute)
Time Frame
6 weeks
Title
Oxygen Saturation (SPO2)
Description
Changes from the Baseline; Saturation in Percentage
Time Frame
6 weeks
Title
Blood Pressure
Description
Changes from the Baseline; Blood Pressure in (mmHg)
Time Frame
6 weeks
Title
Heart Rate Reserve
Description
Changes from the Baseline; Heart Rate Reserve beat per minute
Time Frame
6 weeks
Title
Respiratory Rate
Description
Changes from the Baseline; Respiratory Rate breath per minute
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: post-operative CABG patients, Ejection fraction >40% were included Exclusion Criteria: 2,3,4 scale of angina, unstable congestive heart failure, Substantial myocardial ischemia, Cardiac arrhythmias, Reopen chest after surgery, Uncontrolled diabetes and hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumaiyah Obaid Baig, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Tai Chi Exercises on Physical Activity and Pulmonary Function in CABG

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