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Circuit Training Program in Post COVID-19 Patients

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Circuit Training Exercise Program
Aerobic Training Exercise Program
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Cardiorespiratory Fitness, Functional Fitness, COVID 19

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Riphah Rehabiliation Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Circuit Training

Aerobic Training

Arm Description

This group preformed interval training alternating between aerobic and resistance training, varying between moderate to high intensity. Each set started with 3 minutes of aerobic training on cycle or treadmill followed by resistance training and a rest interval. Eight circuits were formed; horizontal rowing, chest press, leg press, shoulder press, leg extension, lateral pull down, leg flexion and partial squat. Weight was calculated through 1 RM calculation. This training is to be carried out for 12 weeks, in three phases, the intensity progressing from light to moderate (30% of RM to 50%). Sessions will be carried out thrice a week.

The control group consists of aerobic exercise training, with 20 minutes on the cycle, 15 minutes of treadmill and 10 minutes of walking

Outcomes

Primary Outcome Measures

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
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
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.
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.
Post-Covid Functional Status Scale (PCFS)
An ordinal tool that is proposed to measure the full spectrum of functional outcomes following COVID-19
Post-Covid Functional Status Scale (PCFS)
An ordinal tool that is proposed to measure the full spectrum of functional outcomes following COVID-19

Secondary Outcome Measures

Full Information

First Posted
March 30, 2022
Last Updated
January 4, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05323331
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Cardiorespiratory Fitness, Functional Fitness, COVID 19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Circuit Training
Arm Type
Experimental
Arm Description
This group preformed interval training alternating between aerobic and resistance training, varying between moderate to high intensity. Each set started with 3 minutes of aerobic training on cycle or treadmill followed by resistance training and a rest interval. Eight circuits were formed; horizontal rowing, chest press, leg press, shoulder press, leg extension, lateral pull down, leg flexion and partial squat. Weight was calculated through 1 RM calculation. This training is to be carried out for 12 weeks, in three phases, the intensity progressing from light to moderate (30% of RM to 50%). Sessions will be carried out thrice a week.
Arm Title
Aerobic Training
Arm Type
Active Comparator
Arm Description
The control group consists of aerobic exercise training, with 20 minutes on the cycle, 15 minutes of treadmill and 10 minutes of walking
Intervention Type
Other
Intervention Name(s)
Circuit Training Exercise Program
Intervention Description
The participants allocated to this group will perform Circuit Training Exercise Program
Intervention Type
Other
Intervention Name(s)
Aerobic Training Exercise Program
Intervention Description
The participants allocated to this group will perform Circuit Training Exercise Program
Primary Outcome Measure Information:
Title
6 Minutes Walk Test
Description
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
Time Frame
Baseline
Title
6 Minutes Walk Test
Description
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
Time Frame
6th Week of Treatment
Title
Rate of Perceived Exertion (RPE 6-20):
Description
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.
Time Frame
Baseline
Title
Rate of Perceived Exertion (RPE 6-20):
Description
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.
Time Frame
6th Week of Treatment
Title
Post-Covid Functional Status Scale (PCFS)
Description
An ordinal tool that is proposed to measure the full spectrum of functional outcomes following COVID-19
Time Frame
Baseline
Title
Post-Covid Functional Status Scale (PCFS)
Description
An ordinal tool that is proposed to measure the full spectrum of functional outcomes following COVID-19
Time Frame
6th Week of Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Middle age adults (40-60 years), medically stable, but previously diagnosed with cardiac diseases. Patients who have recovered recently from Covid-19 (6-8 weeks post-discharge). Oxygen saturation levels are maintained above 92% at rest and during exercise. 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) Systolic blood pressure should be ≥90 mmHg and ≤180 mmHg. Symptoms of dyspnea: Borg scale >4 Fatigue: Rate of Perceived Exertion (RPE) >11-12 Exclusion Criteria There are signs of active infection/systemic illness going on, presence of fatigue and breathlessness even at rest. Participant is febrile (body temperature >38.6degree Celsius) Oxygen Saturation levels below <93%. Systolic Blood pressure <90 mmHg or >180mmHg. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danish Hassan, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabiliation Clinic
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54770
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33013925
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.
Results Reference
background
PubMed Identifier
35056603
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.
Results Reference
background
PubMed Identifier
33364571
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.
Results Reference
background
PubMed Identifier
33801080
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.
Results Reference
background
PubMed Identifier
33494244
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.
Results Reference
background

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Circuit Training Program in Post COVID-19 Patients

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