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CompletedNCT05357937Updated May 3, 2022

Structured Physiotherapy Program in Obese and Non-obese Patients

An interventional study of standard physiotherapy program in Coronary Artery Disease and Obesity, sponsored by University of Jazan. Completed at 1 site in Saudi Arabia. Open to participants aged Up to 69 Years. Per ClinicalTrials.gov, last updated 2022-05-03.

Sponsored by University of Jazan · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Dec 2020, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
Up to 69 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Coronary Artery Disease
  • Obesity

Keywords

  • Coronary artery bypass grafting
  • Obesity
  • Rehabilitation
  • Spirometry
  • Six Minute walk Test
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 50 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University of Jazan is the lead sponsor of 31 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • People aged 70 years or older, or who had any orthopedic or neurological difficulties were excluded from the trial.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Obese group

    Received standard physiotherapy program

    Behavioral: standard physiotherapy program

  • Active comparator
    Non-Obese group

    Received standard physiotherapy program

    Behavioral: standard physiotherapy program

Interventions

  • Behavioralstandard physiotherapy program

    A qualified physical therapist administered a structured physiotherapy program from day 1 to day 7 in both groups

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: day 7

  2. 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.

    Time frame: day 7

07

Study locations

1 site
  • Jazan University
    Jazan, Saudi Arabia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05357937
Lead sponsor
University of Jazan
Responsible party
Dr. Mohammad Abu Shaphe (Associate Professor, University of Jazan) — Principal investigator
First posted
May 3, 2022
Start date
Dec 16, 2020
Primary completion
Dec 18, 2021
Completion
Dec 18, 2021
Last update
May 3, 2022

Study contacts

Associate Professor
principal investigator · University of Jazan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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