Circuit Training Program in Post COVID-19 Patients

January 4, 2023 updated by: Riphah International University

Effects of Circuit Training Program on Cardiopulmonary Parameters and Functional Capacity in Post COVID 19 Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54770
        • Riphah Rehabiliation Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Circuit Training

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.
Other: Circuit Training Exercise Program
The participants allocated to this group will perform Circuit Training Exercise Program
Active Comparator: Aerobic Training
The control group consists of aerobic exercise training, with 20 minutes on the cycle, 15 minutes of treadmill and 10 minutes of walking
Other: Aerobic Training Exercise Program
The participants allocated to this group will perform Circuit Training Exercise Program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6 Minutes Walk Test
Time Frame: Baseline
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
6 Minutes Walk Test
Time Frame: 6th Week of Treatment
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
Rate of Perceived Exertion (RPE 6-20):
Time Frame: Baseline
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
Rate of Perceived Exertion (RPE 6-20):
Time Frame: 6th Week of Treatment
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
Post-Covid Functional Status Scale (PCFS)
Time Frame: Baseline
An ordinal tool that is proposed to measure the full spectrum of functional outcomes following COVID-19
Baseline
Post-Covid Functional Status Scale (PCFS)
Time Frame: 6th Week of Treatment
An ordinal tool that is proposed to measure the full spectrum of functional outcomes following COVID-19
6th Week of Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RiphahIU Hira Haumayun

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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