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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05323331
Other study ID # RiphahIU Hira Haumayun
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date December 1, 2022

Study information

Verified date January 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study will be to compare the effects of Circuit Training Program on Cardiopulmonary Parameters and Functional Capacity in Post COVID 19 patients. This study will be a Randomized Clinical trial. Data will be collected from Boston Physiotherapy and Wellness Clinic, Lahore. One group will receive Circuit Training and other group will receive Aerobic Exercises. All subjects will receive a total of three treatment sessions per week over the period of 12 weeks. Outcome will be measured at baseline, 6th week and 12th week with 6 Minute Walk Test (6MWT), Rate of Perceived Exertion (RPE 6-20), Spirometer for PFT and Post-Covid 10 Functional Status Scale.The data will be analyse using SPSS v 25.


Description:

Coronavirus disease (Covid19) caused by SARs Cov-2 is primarily a respiratory condition but it also has many extrapulmonary manifestations leading to persistent symptoms of fatigue, weakness, reduced functional status, aerobic capacity and strength. Patients with cardiovascular and pulmonary comorbidities have varying severity of disease and increased risk of mortality and morbidity. Cardiopulmonary Rehabilitation has been shown to improve the functional capacity and quality of life of patients with cardiac dysfunction and chronic pulmonary conditions in acute, sub-acute and chronic stages of disease. Different modes of exercises including aerobic, resistance, combined aerobic and resistance programs known as circuit training at varying frequencies, intensities and doses are given to these patients according to their symptoms. Circuit Training program consists of both aerobic and resistance exercises hence it ensures both endurance and strength training during the exercise session. Some researchers have shown that circuit-based resistance training, where lighter loads are lifted with minimal rest, is very effective for increasing maximum oxygen consumption, maximum pulmonary ventilation, functional capacity, and strength while improving body composition Thus, circuit training is a time-efficient training modality that can elicit demonstrable improvements in health and physical fitness.Combined aerobic and resistance training improves peak VO2, muscle strength and HRQoL and should be considered as a component of care of patients of heart failure. The combination of resistance and aerobic modalities has been shown to be the best form of training for individuals with pulmonary conditions like COPD as well as being recommended by international guidelines for the clinical treatment of these patients in rehabilitation programs. The same principles apply to management of Covid19 patients with inpatient rehabilitation given to acute cases while increasing evidence shows that rehabilitation post-recovery is beneficial to promote early return to function. These studies focus mostly either on aerobic training or resistance exercises; hence this study is aimed towards studying the effects of Circuit Training in post Covid19 population to improve the functional parameters.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: 1. Middle age adults (40-60 years), medically stable, but previously diagnosed with cardiac diseases. 2. Patients who have recovered recently from Covid-19 (6-8 weeks post-discharge). 3. Oxygen saturation levels are maintained above 92% at rest and during exercise. 4. Heart Rate should not be elevated more than 20 beats per minute as per the calculated heart rate range (if the patient is on beta-blockers, that should be kept in consideration) 5. Systolic blood pressure should be =90 mmHg and =180 mmHg. 6. Symptoms of dyspnea: Borg scale >4 7. Fatigue: Rate of Perceived Exertion (RPE) >11-12 Exclusion Criteria 1. There are signs of active infection/systemic illness going on, presence of fatigue and breathlessness even at rest. 2. Participant is febrile (body temperature >38.6degree Celsius) 3. Oxygen Saturation levels below <93%. 4. Systolic Blood pressure <90 mmHg or >180mmHg. -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Circuit Training Exercise Program
The participants allocated to this group will perform Circuit Training Exercise Program
Aerobic Training Exercise Program
The participants allocated to this group will perform Circuit Training Exercise Program

Locations

Country Name City State
Pakistan Riphah Rehabiliation Clinic Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Abdelrahman Z, Li M, Wang X. Comparative Review of SARS-CoV-2, SARS-CoV, MERS-CoV, and Influenza A Respiratory Viruses. Front Immunol. 2020 Sep 11;11:552909. doi: 10.3389/fimmu.2020.552909. eCollection 2020. — View Citation

Calabrese M, Garofano M, Palumbo R, Di Pietro P, Izzo C, Damato A, Venturini E, Iesu S, Virtuoso N, Strianese A, Ciccarelli M, Galasso G, Vecchione C. Exercise Training and Cardiac Rehabilitation in COVID-19 Patients with Cardiovascular Complications: State of Art. Life (Basel). 2021 Mar 21;11(3):259. doi: 10.3390/life11030259. — View Citation

Louis TJ, Qasem A, Abdelli LS, Naser SA. Extra-Pulmonary Complications in SARS-CoV-2 Infection: A Comprehensive Multi Organ-System Review. Microorganisms. 2022 Jan 12;10(1):153. doi: 10.3390/microorganisms10010153. — View Citation

Scudiero O, Lombardo B, Brancaccio M, Mennitti C, Cesaro A, Fimiani F, Gentile L, Moscarella E, Amodio F, Ranieri A, Gragnano F, Laneri S, Mazzaccara C, Di Micco P, Caiazza M, D'Alicandro G, Limongelli G, Calabro P, Pero R, Frisso G. Exercise, Immune System, Nutrition, Respiratory and Cardiovascular Diseases during COVID-19: A Complex Combination. Int J Environ Res Public Health. 2021 Jan 21;18(3):904. doi: 10.3390/ijerph18030904. — View Citation

Siddiq MAB, Rathore FA, Clegg D, Rasker JJ. Pulmonary Rehabilitation in COVID-19 patients: A scoping review of current practice and its application during the pandemic. Turk J Phys Med Rehabil. 2020 Nov 9;66(4):480-494. doi: 10.5606/tftrd.2020.6889. eCollection 2020 Dec. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 6 Minutes Walk Test A simple 6 minutes' walk test (6MWT) is a reliable tool to assess cardiorespiratory effort tolerance in chronic lung and chronic heart failure patients. The test provides a global assessment of the cardio pulmonary reserves Baseline
Primary 6 Minutes Walk Test A simple 6 minutes' walk test (6MWT) is a reliable tool to assess cardiorespiratory effort tolerance in chronic lung and chronic heart failure patients. The test provides a global assessment of the cardio pulmonary reserves 6th Week of Treatment
Primary Rate of Perceived Exertion (RPE 6-20): The Borg Rating of Perceived Exertion (RPE) scale is a subjective assessment of how hard someone feels they are working and can be helpful to guide people in choosing what activities to do as they progress through the phases of increasing physical activity. Baseline
Primary Rate of Perceived Exertion (RPE 6-20): The Borg Rating of Perceived Exertion (RPE) scale is a subjective assessment of how hard someone feels they are working and can be helpful to guide people in choosing what activities to do as they progress through the phases of increasing physical activity. 6th Week of Treatment
Primary Post-Covid Functional Status Scale (PCFS) An ordinal tool that is proposed to measure the full spectrum of functional outcomes following COVID-19 Baseline
Primary Post-Covid Functional Status Scale (PCFS) An ordinal tool that is proposed to measure the full spectrum of functional outcomes following COVID-19 6th Week of Treatment
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