Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05357937 |
Other study ID # |
Ref No: 05/JUREC/14PT.2020 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 16, 2020 |
Est. completion date |
December 18, 2021 |
Study information
Verified date |
April 2022 |
Source |
University of Jazan |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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).