Post-cardiac SurgeryNCT04615481
Elliptical Training Versus Ergo-meter on Cardiopulmonary Parameters in Post CABG Patients
A study testing Elliptical Training Group and Ergo-metric Training Group in people with Post-cardiac Surgery, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of elliptical training versus ergo-meter on cardiopulmonary parameters in post CABG patients Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Post-cardiac Surgery
- What is being tested?
- Elliptical Training Group and Ergo-metric Training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Sep 2020to 20 Dec 2020
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- CABG patients (after 4 months) undergone phase 2 rehabilitation.
Who cannot join
- Vitally Unstable patients
- Presence of arrhythmias
- History of unstable angina in last 3 months
- Intracavitary thrombus
- Recent thrombophlebitis with or without pulmonary embolism
- Sever/e obstructive cardiomyopathies
- Uncontrolled diabetes
- Severe orthopaedic problems
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rawalpindi Institute of Cardiology
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effects of Elliptical Training Versus Ergo-meter on Cardiopulmonary Parameters in Post CABG Patients
To determine the effects of elliptical training versus ergo-meter on cardiopulmonary parameters in post CABG patients
Read the detailed description
Worldwide, physiotherapists treat patients with CAD in the acute stage following a coronary event and/ or following coronary artery bypass graft (CABG) surgery. These patients are then later followed up as outpatients during cardiac rehabilitation(CR) in turn to improve cardio-respiratory fitness and quality of life and to delay the incidence of subsequent coronary events. Early mobilisation and physical activity is often the first choice of treatment, but evidence as to the optimal intensity, timing and choice of exercises is scarce. In 2018 the effect of obesity on functional capacity, anxiety and Daily life activities in patients with coronary artery disease and phase II cardiac rehabilitation. The results shows that When Group 1 patients were assessed at the end of 30 sessions of cardiac rehabilitation (CR) program, a statistically significant improvement was detected in 6MWT, physical functioning, physical role, mental health, social functioning and pain sub parameters.
In 2019, study Changes in 6-minute walk test (6MWT) distance and heart rate walking speed index following a cardiovascular prevention and rehabilitation programme .Patients increased their 6-minute walk test distance by 40 meters and decreased their heart rate walking speed index by 2.7, which translates into a saving of three heart beats for every 100 meters walked or 45 heart beats for every mile walked.
In 2012, conducted study Resistance and Balance Training Improves Functional Capacity in Very Old Participants Attending Cardiac Rehabilitation Participants were assigned randomly in a ratio of 1:1 to an intervention group (IG; inpatient CR plus resistance training and balance training) or control group (CG;inpatient CR)after Coronary Bypass Surgery. The study concluded that there is significantly greater improvement in functional capacity measured as 6-MWD,TUG time, and maximal relative workload in the IG than in the CG..
- Conditions
- Post-cardiac Surgery
- Being tested
- Elliptical Training Group, Ergo-metric Training Group
- Keywords
- Ergo-meter, CABG, Endurance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elliptical Training GroupOther
The training program will be consisted of total 30 minutes of elliptical cross training (5 minutes warm up + Progressive Training up to 20 minutes of elliptical cross training + 5 minutes cool down) for 3 days in a week for 4 weeks at an average intensity of 50-70% the maximal heart rate according to ACSM guidelines.
Ergo-metric Training GroupOther
The training program will be consisted of total 30 minutes of ergometric training (5 minutes warm up + Progressive Training up to 10 minutes of upper limb ergometric training + Progressive Training up to 10 minutes of lower limb ergometric training+5 minutes cool down) for 3 days in a week for 4 weeks at an average intensity of 50-70% the maximal heart rate according to ACSM guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Elliptical Training Group | Experimental | Total 30 minutes of elliptical cross training, including warm up, progressive elliptical training and cool down. Receives: Other: Elliptical Training Group |
| Ergo-metric Training Group | Experimental | Total 30 minutes of ergometric training Receives: Other: Ergo-metric Training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 min walk test: Distance (meters)
Changes from the baseline, 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.
Measured: 4th week
Oxygen Saturation (SpO2)
Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.
Measured: 4th week
Pulse Rate
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
Measured: 4th week
Modified Borg Scale of Perceived Exertion
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
Measured: 4th week
Systolic and diastolic blood pressure
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Measured: 4th week
WHO_BREF questioner (Quality of life)
Changes for the baseline, The World Health Organization (WHO) Quality of Life Group Developed a self-report 26 item questionnaire called the WHO Quality of Life Instrument, Short Form (WHOQOLBREF).the questioner is intend to assess the four aspect of quality of life physical (seven questions), psychological (six questions), social (three questions), and environmental (eight questions) dimensions.There are no cut-off points above or below which quality of life could be evaluated as "poor" or "good". Thus, it was decided to rationalize the analysis by defining two groups at the extremes, both in perception of QoL and satisfaction with health (good QoL /satisfied - includes those who reported having good or very good QoL and were satisfied or very satisfied with their health; and poor QoL /dissatisfied - includes those who reported poor or very poor QoL and who were dissatisfied or very dissatisfied with their health).
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start8 Sep 2020
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqbal Tariq, MsCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615481
- Sponsor's protocol ID
- REC/00712 Shafaq Wadood
- Status last verified
- Jan 2021
- First submitted
- 3 Nov 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ab Manap N, Khalid KBMKM, Alias MNBA, Jamaludin NB. Quality of Life among Post Acute Myocardial Infarction Patient. ILKKM Journal of Medical and Health Sciences. 2019;1(1):20-4.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Elliptical Training Versus Ergo-meter on Cardiopulmonary Parameters in Post CABG Patients
- ClinicalTrials.gov ID
- NCT04615481
- Acronym / sponsor ID
- REC/00712 Shafaq Wadood
- Conditions
- Post-cardiac Surgery
- Keywords
- Ergo-meter, CABG, Endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 4 Nov 2020 (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.
To determine the effects of elliptical training versus ergo-meter on cardiopulmonary parameters in post CABG patients
Detailed description
Worldwide, physiotherapists treat patients with CAD in the acute stage following a coronary event and/ or following coronary artery bypass graft (CABG) surgery. These patients are then later followed up as outpatients during cardiac rehabilitation(CR) in turn to improve cardio-respiratory fitness and quality of life and to delay the incidence of subsequent coronary events. Early mobilisation and physical activity is often the first choice of treatment, but evidence as to the optimal intensity, timing and choice of exercises is scarce. In 2018 the effect of obesity on functional capacity, anxiety and Daily life activities in patients with coronary artery disease and phase II cardiac rehabilitation. The results shows that When Group 1 patients were assessed at the end of 30 sessions of cardiac rehabilitation (CR) program, a statistically significant improvement was detected in 6MWT, physical functioning, physical role, mental health, social functioning and pain sub parameters.
In 2019, study Changes in 6-minute walk test (6MWT) distance and heart rate walking speed index following a cardiovascular prevention and rehabilitation programme .Patients increased their 6-minute walk test distance by 40 meters and decreased their heart rate walking speed index by 2.7, which translates into a saving of three heart beats for every 100 meters walked or 45 heart beats for every mile walked.
In 2012, conducted study Resistance and Balance Training Improves Functional Capacity in Very Old Participants Attending Cardiac Rehabilitation Participants were assigned randomly in a ratio of 1:1 to an intervention group (IG; inpatient CR plus resistance training and balance training) or control group (CG;inpatient CR)after Coronary Bypass Surgery. The study concluded that there is significantly greater improvement in functional capacity measured as 6-MWD,TUG time, and maximal relative workload in the IG than in the CG..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Elliptical Training Group | Experimental | Other: Elliptical Training GroupTotal 30 minutes of elliptical cross training, including warm up, progressive elliptical training and cool down. |
| Ergo-metric Training Group | Experimental | Other: Ergo-metric Training GroupTotal 30 minutes of ergometric training |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- CABG patients (after 4 months) undergone phase 2 rehabilitation.
Key exclusion criteria (8 listed)
- Vitally Unstable patients
- Presence of arrhythmias
- History of unstable angina in last 3 months
- Intracavitary thrombus
- Recent thrombophlebitis with or without pulmonary embolism
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 |
|---|---|---|
| Elliptical Training GroupThe training program will be consisted of total 30 minutes of elliptical cross training (5 minutes warm up + Progressive Training up to 20 minutes of elliptical cross training + 5 minutes cool down) for 3 days in a week for 4 weeks at an average intensity of 50-70% the maximal heart rate according to ACSM guidelines. | Other | Elliptical Training Group |
| Ergo-metric Training GroupThe training program will be consisted of total 30 minutes of ergometric training (5 minutes warm up + Progressive Training up to 10 minutes of upper limb ergometric training + Progressive Training up to 10 minutes of lower limb ergometric training+5 minutes cool down) for 3 days in a week for 4 weeks at an average intensity of 50-70% the maximal heart rate according to ACSM guidelines. | Other | Ergo-metric Training Group |
Primary outcome
6 min walk test: Distance (meters)
Time frame: 4th week
Changes from the baseline, 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.
Oxygen Saturation (SpO2)
Time frame: 4th week
Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.
Pulse Rate
Time frame: 4th week
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
Modified Borg Scale of Perceived Exertion
Time frame: 4th week
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
Systolic and diastolic blood pressure
Time frame: 4th week
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
WHO_BREF questioner (Quality of life)
Time frame: 4th week
Changes for the baseline, The World Health Organization (WHO) Quality of Life Group Developed a self-report 26 item questionnaire called the WHO Quality of Life Instrument, Short Form (WHOQOLBREF).the questioner is intend to assess the four aspect of quality of life physical (seven questions), psychological (six questions), social (three questions), and environmental (eight questions) dimensions.There are no cut-off points above or below which quality of life could be evaluated as "poor" or "good". Thus, it was decided to rationalize the analysis by defining two groups at the extremes, both in perception of QoL and satisfaction with health (good QoL /satisfied - includes those who reported having good or very good QoL and were satisfied or very satisfied with their health; and poor QoL /dissatisfied - includes those who reported poor or very poor QoL and who were dissatisfied or very dissatisfied with their health).
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 13 Jan 2021.
- BackgroundAb Manap N, Khalid KBMKM, Alias MNBA, Jamaludin NB. Quality of Life among Post Acute Myocardial Infarction Patient. ILKKM Journal of Medical and Health Sciences. 2019;1(1):20-4.
- 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.
Iqbal Tariq, MsCPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elliptical Training Group and Ergo-metric Training Group in people with Post-cardiac Surgery, run by Riphah International University at 1 site in Pakistan.
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 8 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 13 Jan 2021. 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 Pakistan. 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?
6 min walk test: Distance (meters) (time frame: 4th week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04615481, which also lists 1 linked publication.
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 13 Jan 2021.