- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07578805
Comparative Effects of Elliptical Exercises and Swiss Ball Aerobics Exercises in Post CABG Patients
Comparative Effects Of Elliptical Exercises And Swiss Ball Aerobics Exercises On Functional Capacity, Heart Rate, Dyspnea , And Quality Of Life In Post CABG Patients
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Coronary artery bypass grafting (CABG) is a widely performed surgical intervention aimed at restoring adequate myocardial perfusion in patients with severe coronary artery disease. Despite its benefits, patients often experience persistent limitations in functional capacity, elevated resting heart rate, and dyspnea, during the postoperative period. Effective rehabilitation strategies are essential to facilitate recovery and enhance quality of life in this population.
This randomized controlled trial aims to compare the effects of two rehabilitation approaches elliptical exercise training and Swiss ball exercise therapy on key clinical and psychological outcomes in post-CABG patients. Patient of post CABG will be selected by convenient sampling technique 32 Participants will be randomly assigned to either group 16 in each group. Group A will be treated by elliptical exercises and B will be treated with Swiss ball exercises and will engage in supervised exercise sessions three times a week for 6 to 8 weeks. Outcomes including functional exercise capacity (measured via the six-minute walk test), resting heart rate (pulse ox), dyspnea (Modified Borg Scale), and quality of life (SF-36) will be evaluated before and after the intervention.
Data will be analyzed using statistical package for social sciences spss. By comparing these two approaches, this research aims to determine which exercise method is more effective in improving both physical parameters and quality of life in post-CABG patients. The results could help improve rehabilitation programs and support faster, more complete recoveries for heart surgery patients.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Imran Amjad, PhD
- Numero di telefono: 03324390125
- Email: imran.amjad@riphah.edu.pk
Luoghi di studio
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Riphah International University
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Investigatore principale:
- Khadija Nawaz, MsPT(CPPT)
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
INCLUSION CRITERIA
- Adult patients aged 40 to 60 years who have undergone elective or scheduled coronary artery bypass grafting (CABG) surgery.
- Post-operative duration between 2 to 6 weeks, medically cleared to begin rehabilitation exercises.
- Hemodynamically stable (normal vital signs, no signs of acute cardiac distress).
- Willing and able to participate in a supervised rehabilitation program.
EXCLUSION CRITERIA
- Patients with unstable angina, recent myocardial infarction (<2 weeks), or uncontrolled arrhythmias.
- Patients with severe valvular heart disease or left ventricular ejection fraction <30%.
- Individuals with neurological conditions (e.g., Parkinson's disease, stroke) that impair mobility or coordination.
- Patients with severe musculoskeletal disorders (e.g., joint replacement, severe arthritis, recent fractures).
- Cognitive impairment (e.g., dementia, significant memory loss) that prevents understanding or following instructions.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Group A
Group A will be recieving elliptical exercise (Steady state moderate intensity protocol on elliptical trainer, interval elliptical training)
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Participants allocated to the this group will undergo a structured aerobic training program using an elliptical trainer.
The exercise prescription will adhere to the FITT framework as follows: frequency of five sessions per week, moderate intensity (targeting approximately 50-70% of heart rate reserve or corresponding Rating of Perceived Exertion of 12-14 on the Borg scale), and duration of 30 minutes per session.
Each session will be supervised and will include appropriate warm-up and cool-down periods according to standard cardiac rehabilitation protocols.
The intervention will be delivered consistently throughout the study period using an elliptical exercise modality.
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Comparatore attivo: Group B
Group B will be recieving swiss ball exercises (Seated arm raises with light weights and bands, seated torso rotation,seated bouncing,arm circles and punches while sitting,diaphragmatic breathing with ball hug, wall squat with swiss ball support).
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Participants allocated to this group will receive a structured exercise program using Swiss ball-based training.
The intervention will follow the FITT principle as follows: frequency of five sessions per week, moderate intensity (corresponding to a Rating of Perceived Exertion of 12-14 on the Borg scale), and duration of 30 minutes per session.
The exercise type will consist of flexibility and breathing exercises performed with the Swiss ball.
Each session will be supervised and will include standardized warm-up and cool-down components in accordance with established rehabilitation protocols.
The intervention will be delivered consistently throughout the study period.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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functional capacity
Lasso di tempo: pretreatment, 4th week, 8th week
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6-Minute Walk Test (6MWT) is a practical and widely used assessment tool to measure exercise capacity and functional status in individuals with various health conditions.
To perform the test, a flat, straight corridor with a measured distance is required.
The individual is instructed to walk at their own pace, aiming to cover as much distance as possible within the 6-minute time frame.
They can slow down, stop, or rest if needed, but the timer continues to run.
The test administrator records the total distance walked, as well as any symptoms, such as shortness of breath or fatigue.
The 6MWT is a valuable tool for assessing exercise capacity improvement, as it reflects an individual's ability to perform daily activities and can be used to monitor changes in functional status over time or in response to interventions, such as exercise training or rehabilitation programs.
By tracking changes in distance walked, healthcare providers can evaluate the effectiveness of treatment plan.
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pretreatment, 4th week, 8th week
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Heart rate
Lasso di tempo: pretreatment, 4th week, 8th week.
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A pulse oximeter, often referred to as a pulse ox, is a small, non-invasive medical device that clips onto a fingertip, toe, or earlobe to measure two critical health metrics: oxygen saturation (SpO2) and heart rate.
Oxygen saturation indicates the percentage of hemoglobin in the blood that is carrying oxygen, while heart rate measures the number of heart beats per minute (bpm).
To use a pulse oximeter for measuring heart rate, simply place the device on the chosen site, ensuring a snug fit, and turn it on.
After a few seconds, the device will display both your oxygen saturation level and heart rate.
It's essential to remain still during measurement to ensure accuracy, as movement can interfere with the readings.
A pulse oximeter is a valuable tool for monitoring heart rate, especially for individuals with heart conditions, respiratory issues, or those engaging in high-altitude activities.
By providing quick and reliable readings, it helps users track their heart rate in real-time.
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pretreatment, 4th week, 8th week.
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Dyspnoea
Lasso di tempo: pretreatment, 4th week, 8th week
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The Modified Borg Scale is a widely used tool to assess the severity of dyspnea (shortness of breath) in patients.
It is a simple, self-reported scale that asks patients to rate the intensity of their breathlessness from 0 to 10, with 0 indicating "no breathlessness" and 10 indicating "maximal breathlessness."
To use the Modified Borg Scale, patients are asked to select a number that corresponds to the severity of their dyspnea, with descriptors provided for each level of severity, such as "slight" (1-2), "moderate" (3-4), "severe" (5-6), and "very severe" (7-10).
This scale helps healthcare providers quantify the impact of dyspnea on patients' daily lives and monitor changes in symptoms over time or in response to treatment.
By regularly assessing dyspnea using the Modified Borg Scale, healthcare providers can tailor interventions to meet individual patient needs, evaluate the effectiveness of treatments, and improve patient outcomes.
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pretreatment, 4th week, 8th week
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Quality of life in post-CABG patients
Lasso di tempo: pretreatment, 4th week , 8th week
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The Short Form 36 (SF-36) is a widely used, multi-dimensional health survey that measures eight domains of health status: physical functioning, bodily pain, general health, vitality, social functioning, emotional functioning, and mental health.
It is a self-reported questionnaire that assesses an individual's perceived health and well-being over a specific period, typically the past four weeks.
The SF-36 is used in various settings, including clinical trials, health services research, and individual patient assessments, to evaluate the impact of diseases, treatments, and interventions on quality of life.
To use the SF-36, patients are asked to complete the questionnaire, which consists of 36 items.
The results provide a comprehensive profile of the patient's health status, allowing healthcare providers to identify areas of strength and weakness, monitor changes over time, and make informed decisions about care.
The SF-36's scores can also be used to compare the health status of differ
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pretreatment, 4th week , 8th week
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Wajeeha Zia, phd, Riphah International University
Pubblicazioni e link utili
Pubblicazioni generali
- Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 Dec 6;58(24):e123-210. doi: 10.1016/j.jacc.2011.08.009. Epub 2011 Nov 7. No abstract available.
- Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.
- Saba MA, Goharpey S, Attarbashi Moghadam B, Salehi R, Nejatian M. Correlation Between the 6-Min Walk Test and Exercise Tolerance Test in Cardiac Rehabilitation After Coronary Artery Bypass Grafting: A Cross-sectional Study. Cardiol Ther. 2021 Jun;10(1):201-209. doi: 10.1007/s40119-021-00210-0. Epub 2021 Feb 13.
- Athanasiou A, Papazachou O, Rovina N, Nanas S, Dimopoulos S, Kourek C. The Effects of Exercise Training on Functional Capacity and Quality of Life in Patients with Rheumatoid Arthritis: A Systematic Review. J Cardiovasc Dev Dis. 2024 May 22;11(6):161. doi: 10.3390/jcdd11060161.
- Bilajac L, Marinovic Glavic M, Kristijan Z, Matea B, Juraga D, Jelakovic A, Rukavina T, Vasiljev V, Jelakovic B. Breaking the Cycle: Enhancing Cardiovascular Health in the Elderly Through Group Exercise. Life (Basel). 2025 Jan 29;15(2):206. doi: 10.3390/life15020206.
- Reed JL, Terada T, Cotie LM, Tulloch HE, Leenen FH, Mistura M, Hans H, Wang HW, Vidal-Almela S, Reid RD, Pipe AL. The effects of high-intensity interval training, Nordic walking and moderate-to-vigorous intensity continuous training on functional capacity, depression and quality of life in patients with coronary artery disease enrolled in cardiac rehabilitation: A randomized controlled trial (CRX study). Prog Cardiovasc Dis. 2022 Jan-Feb;70:73-83. doi: 10.1016/j.pcad.2021.07.002. Epub 2021 Jul 7.
- Ciftci H, Korkut S, Karaca S. The Effect of Breathing Exercise With Incentive Spirometer on Pain, Anxiety, Comfort, and Physiological Parameters Before and After Cardiac Surgery: A Randomized Controlled Experimental Study. J Perianesth Nurs. 2025 Dec;40(6):1460-1468. doi: 10.1016/j.jopan.2025.02.005. Epub 2025 Jun 9.
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- Khadija Nawaz
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