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Structured Physiotherapy Program in Obese and Non-obese Patients

Primary Purpose

Coronary Artery Disease, Obesity

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
standard physiotherapy program
Sponsored by
University of Jazan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring Coronary artery bypass grafting, Obesity, Rehabilitation, Spirometry, Six Minute walk Test

Eligibility Criteria

undefined - 69 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both obese and non-obese patient awaiting Coronary artery bypass graft

Exclusion Criteria:

  • People aged 70 years or older, or who had any orthopedic or neurological difficulties were excluded from the trial.

Sites / Locations

  • Jazan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Obese group

Non-Obese group

Arm Description

Received standard physiotherapy program

Received standard physiotherapy program

Outcomes

Primary Outcome Measures

Mean changes in pulmonary function
Pulmonary functions were measured using the spirometry tests in the Vitalograph 2120 in accordance with established guidelines. At least three times, the readings were taken, and the best result was used. A posttest spirometry was performed on day 4 and 7 postoperatively.
Mean changes in distance walked during six-minute walk test
A six-minute walk (6-MWT) test was conducted at baseline and on day 7 postoperatively . Patients were advised to walk back and forth on the walking path at their own pace for 6-MWT. They were given six minutes to cover as much ground as possible. When 4 and 2 minutes remained in the test, prompts were offered. We utilized the following standardized prompt: "You're down to the final two (or four) minutes. You are doing an excellent job. You may accelerate or decelerate at any time, maintain the same pace, or take a break if necessary. Simply attempt to travel as much distance as possible in the remaining time. You are doing an excellent job." After six minutes, the participant's total distance traveled was recorded, along with a Borg dyspnea scale rating.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2022
Last Updated
May 2, 2022
Sponsor
University of Jazan
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1. Study Identification

Unique Protocol Identification Number
NCT05357937
Brief Title
Structured Physiotherapy Program in Obese and Non-obese Patients
Official Title
The Impact of a Structured Physiotherapy Program on Pulmonary Function and Walking Capacity in Obese and Non-obese People Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
December 18, 2021 (Actual)
Study Completion Date
December 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jazan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A routine physiotherapy program has been shown to be effective in the prevention and treatment of cardiopulmonary diseases. It also significantly increases functional capacity following coronary artery bypass grafting. However, the effect of a structured physiotherapy program in obese and non-obese patients has not been well explored. As such, the objective of this study is to determine the effect of a standardized physiotherapy program on pulmonary function and walking capacity in obese and non-obese patients undergoing coronary artery bypass grafting. A prospective study was conducted on 50 obese and non-obese individuals who were schedule for coronary artery bypass grafting. Their body mass index was used to separate them into two groups. Both groups followed a structured physiotherapy program from day 1 to day 7 post cardiac surgery. Both groups underwent spirometry and a six-minute walk test at baseline (preoperatively) and after day 4 and day 7 postoperatively. The effect of physiotherapy program on pulmonary function and 6-MWT was assessed using an independent t-test. To estimate the percentage increase or decrease of pulmonary function and distance during 6-MWT for obese and non-obese groups, the percent difference between baseline and posttest data was calculated and compared using an independent t-test. When the normality test failed, the Mann Whitney U test and analysis of variance on rank were used. Chi-square test was used for gender distribution. The results were considered statistically significant if p ≤ 0.05.
Detailed Description
METHODS Study participants and data collection The Research Ethics Committee of Jazan University, Saudi Arabia gave its approval to this study (Ref No: 05/JUREC/14PT.2020). Prior to participation, each participant signed an informed consent form. All experiments were carried out in line with the Helsinki Declaration. A prospective study was conducted on 50 consecutive individuals (26 obese, 24 non-obese). People aged 70 years or older, or who had any orthopedic or neurological difficulties were excluded from the trial. People were informed about the trial and consented in writing. Following enrollment, participants were placed into two groups according to their BMI. Participants in Group A were obese, defined as having a BMI of > 30 to < 35 kg/m2. Participants in Group B were non-obese, defined as having a BMI of > 25 to < 29.9 kg/m2. Subjective ratings and spirometry data were taken at baseline. All spirometry tests were performed in the sitting position using the Vitalograph 2120 in accordance with established guidelines. At least three times, the readings were taken, and the best result was used. A posttest spirometry was performed on day 4 and 7 postoperatively. A six-minute walk (6-MWT) test was conducted at baseline and on day 7 postoperatively. Patients were advised to walk back and forth on the walking path at their own pace for 6-MWT. They were given six minutes to cover as much ground as possible. When 4 and 2 minutes remained in the test, prompts were offered. We utilized the following standardized prompt: "You're down to the final two (or four) minutes. You are doing an excellent job. You may accelerate or decelerate at any time, maintain the same pace, or take a break if necessary. Simply attempt to travel as much distance as possible in the remaining time. You are doing an excellent job." After six minutes, the participant's total distance traveled was recorded, along with a Borg dyspnea scale rating. A qualified physical therapist administered a structured physiotherapy program from day 1 to day 7 in both groups. Statistical analysis The descriptive variables are expressed as mean ± standard deviation. The effect of physiotherapy program on pulmonary function and 6-MWT was assessed using an independent t-test. To estimate the percentage increase or decrease of pulmonary function and distance during 6-MWT for obese and non-obese groups, the percent difference between baseline and posttest data was calculated and compared using an independent t-test. When the normality test failed, the Mann Whitney U test and analysis of variance on rank were used. Chi-square test was used for gender distribution. The results were considered statistically significant if p ≤ 0.05. Statistical analyses were performed using the Statistical Package for Social Sciences (SPSS, Windows version-17.0, SPSS Chicago. IL, USA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Obesity
Keywords
Coronary artery bypass grafting, Obesity, Rehabilitation, Spirometry, Six Minute walk Test

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obese group
Arm Type
Active Comparator
Arm Description
Received standard physiotherapy program
Arm Title
Non-Obese group
Arm Type
Active Comparator
Arm Description
Received standard physiotherapy program
Intervention Type
Behavioral
Intervention Name(s)
standard physiotherapy program
Intervention Description
A qualified physical therapist administered a structured physiotherapy program from day 1 to day 7 in both groups
Primary Outcome Measure Information:
Title
Mean changes in pulmonary function
Description
Pulmonary functions were measured using the spirometry tests in the Vitalograph 2120 in accordance with established guidelines. At least three times, the readings were taken, and the best result was used. A posttest spirometry was performed on day 4 and 7 postoperatively.
Time Frame
day 7
Title
Mean changes in distance walked during six-minute walk test
Description
A six-minute walk (6-MWT) test was conducted at baseline and on day 7 postoperatively . Patients were advised to walk back and forth on the walking path at their own pace for 6-MWT. They were given six minutes to cover as much ground as possible. When 4 and 2 minutes remained in the test, prompts were offered. We utilized the following standardized prompt: "You're down to the final two (or four) minutes. You are doing an excellent job. You may accelerate or decelerate at any time, maintain the same pace, or take a break if necessary. Simply attempt to travel as much distance as possible in the remaining time. You are doing an excellent job." After six minutes, the participant's total distance traveled was recorded, along with a Borg dyspnea scale rating.
Time Frame
day 7

10. Eligibility

Sex
All
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both obese and non-obese patient awaiting Coronary artery bypass graft Exclusion Criteria: People aged 70 years or older, or who had any orthopedic or neurological difficulties were excluded from the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Associate Professor
Organizational Affiliation
Jazan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jazan University
City
Jazan
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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Structured Physiotherapy Program in Obese and Non-obese Patients

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