NCT05323331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

March 30, 2022

Last Update Submit

January 4, 2023

Conditions

Keywords

Cardiorespiratory FitnessFunctional FitnessCOVID 19

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • Post-Covid Functional Status Scale (PCFS)

    An ordinal tool that is proposed to measure the full spectrum of functional outcomes following COVID-19

    Baseline

  • 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

Study Arms (2)

Circuit Training

EXPERIMENTAL

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

Aerobic Training

ACTIVE COMPARATOR

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

Interventions

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

Circuit Training

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

Aerobic Training

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabiliation Clinic

Lahore, Punjab Province, 54770, Pakistan

Location

Related 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.

    PMID: 33013925BACKGROUND
  • 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.

    PMID: 35056603BACKGROUND
  • 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.

    PMID: 33364571BACKGROUND
  • 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.

    PMID: 33801080BACKGROUND
  • 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.

    PMID: 33494244BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Danish Hassan, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 12, 2022

Study Start

April 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations