Clinical trial NCT05323331: Circuit Training Program in Post COVID-19 Patients
Official title: Effects of Circuit Training Program on Cardiopulmonary Parameters and Functional Capacity in Post COVID 19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Cardiorespiratory Fitness
Functional Fitness
COVID 19
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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. -

Primary outcomes:
measure: 6 Minutes Walk Test
timeFrame: Baseline
measure: 6 Minutes Walk Test
timeFrame: 6th Week of Treatment
measure: Rate of Perceived Exertion (RPE 6-20):
timeFrame: Baseline
measure: Rate of Perceived Exertion (RPE 6-20):
timeFrame: 6th Week of Treatment
measure: Post-Covid Functional Status Scale (PCFS)
timeFrame: Baseline
measure: Post-Covid Functional Status Scale (PCFS)
timeFrame: 6th Week of Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabiliation Clinic
state: Punjab
Study officials:
affiliation: Riphah International University
name: Danish Hassan, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.