Coronary Artery DiseaseNCT05357937
Structured Physiotherapy Program in Obese and Non-obese Patients
A study testing standard physiotherapy program in people with Coronary Artery Disease and Obesity, run by University of Jazan at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages Up to 69 years
- Conditions the study is for
- Coronary Artery Disease, Obesity
- What is being tested?
- standard physiotherapy program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 16 Dec 2020to 18 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both obese and non-obese patient awaiting Coronary artery bypass graft
Who cannot join
- People aged 70 years or older, or who had any orthopedic or neurological difficulties were excluded from the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a Structured Physiotherapy Program on Pulmonary Function and Walking Capacity in Obese and Non-obese People Undergoing Cardiac Surgery
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).
- Conditions
- Coronary Artery Disease, Obesity
- Being tested
- standard physiotherapy program
- Keywords
- Coronary artery bypass grafting, Obesity, Rehabilitation, Spirometry, Six Minute walk Test
- Medical subject headings
- Coronary Artery Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard physiotherapy programBehavioural
A qualified physical therapist administered a structured physiotherapy program from day 1 to day 7 in both groups
| Study group | Role | What they receive |
|---|---|---|
| Obese group | Active comparator | Received standard physiotherapy program Receives: Behavioral: standard physiotherapy program |
| Non-Obese group | Active comparator | Received standard physiotherapy program Receives: Behavioral: standard physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start16 Dec 2020
- Primary completion18 Dec 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Mohammad Abu Shaphe, University of Jazan
- Investigators
- Associate Professor, Principal investigator, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357937
- Sponsor's protocol ID
- Ref No: 05/JUREC/14PT.2020
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Structured Physiotherapy Program on Pulmonary Function and Walking Capacity in Obese and Non-obese People Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05357937
- Acronym / sponsor ID
- Ref No: 05/JUREC/14PT.2020
- Conditions
- Coronary Artery Disease, Obesity
- Keywords
- Coronary artery bypass grafting, Obesity, Rehabilitation, Spirometry, Six Minute walk Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of JazanOther government
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 18 Dec 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese group | Active comparator | Behavioral: standard physiotherapy programReceived standard physiotherapy program |
| Non-Obese group | Active comparator | Behavioral: standard physiotherapy programReceived standard physiotherapy program |
Who may qualify
- Ages
- Up to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Both obese and non-obese patient awaiting Coronary artery bypass graft
Key exclusion criteria (1 listed)
- People aged 70 years or older, or who had any orthopedic or neurological difficulties were excluded from the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard physiotherapy programA qualified physical therapist administered a structured physiotherapy program from day 1 to day 7 in both groups | Behavioural | Non-Obese group, Obese group |
Primary outcome
Mean changes in pulmonary function
Time frame: day 7
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
Time frame: day 7
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Associate Professor principal investigator
University of Jazan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard physiotherapy program in people with Coronary Artery Disease and Obesity, run by University of Jazan at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean changes in pulmonary function (time frame: day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.