Structured Physiotherapy Program in Obese and Non-obese Patients

NCT05357937 | Completed

• 1 other identifier: Ref No: 05/JUREC/14PT.2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Obesity

Keywords

Coronary artery bypass grafting; Obesity; Rehabilitation; Spirometry; Six Minute walk Test

Outcome Measures

Primary Outcomes (2)

• 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.

  day 7

• 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.

  day 7

Study Arms (2)

Obese group

ACTIVE COMPARATOR

Received standard physiotherapy program

Behavioral: standard physiotherapy program

Non-Obese group

ACTIVE COMPARATOR

Received standard physiotherapy program

Behavioral: standard physiotherapy program

Interventions

standard physiotherapy program BEHAVIORAL

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

Non-Obese group; Obese group

Eligibility Criteria

• Age: Up to 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Jazan: lead

Study Sites (1)

Jazan University

Jizan, Saudi Arabia

Location

MeSH Terms

Conditions

Coronary Artery Disease; Obesity

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Associate Professor

  University of Jazan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: May 3, 2022
• Study Start: December 16, 2020
• Primary Completion: December 18, 2021
• Study Completion: December 18, 2021
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)