NCT04445376

Brief Summary

In some patients, lung function declined by about 20 to 30% after recovery. Computer tomography of COVID-19 patients revealed a ground glass opacity in both lungs. We will measure the Cardiorespiratory fitness according to American College of Sports medicine guidline and provide physiotherapy exercise to the patients to measure the improvement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable covid19

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

June 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

July 3, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2020

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

June 22, 2020

Last Update Submit

October 6, 2020

Conditions

Covid19

Keywords

Cardiorespiratory fitness

Outcome Measures

Primary Outcomes (2)

  • 6 minute walk test

    To measure the cardio-respiratory fitness.

    5 weeks

  • Modified Borg Dyspnea Scale

    It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.

    5 weeks

Secondary Outcomes (1)

  • SF-36 QUESTIONNAIRE

    5 weeks

Study Arms (2)

Intervention Group (Ventilatory)

EXPERIMENTAL

Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week.

Other: Physical Exercises

Intervention (Non ventilatory)

EXPERIMENTAL

Breathing Exercise and Aerobic Training will be provided to all the patients.The training session will be given 3 days a week.

Other: Physical Exercises

Interventions

Physical ExercisesOTHER

Aerobic Training and Breathing Exercises.

Intervention (Non ventilatory)Intervention Group (Ventilatory)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recovered from COVID 19 disease (PCR report).
  • Sub-normal performance as compared to normative data.
  • Do not have any Respiratory Problem.
  • Consent to participate in the study.
  • Able to understand and perform the exercise.
  • Age from 18 to 75.
  • Dyspnea due to COVID19.
  • Modified Borg Dyspnea Scale score at least 2 but less than 7.

You may not qualify if:

  • Not suffered from COVID 19.
  • Respiratory Problem.
  • Resting Blood Pressure greater than 160/100 instead of taking medicine
  • Greater than 1-month post COVID19 Recovery.
  • Cardiorespiratory comorbidities which limit participation in exercise.
  • Any Musculoskeletal problem which limit participation in Training.
  • Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal blood pressure responses or ST-segment depression \> 2mm, symptomatic aortic stenosis, complex arrhythmias).
  • Unstable angina
  • Orthostatic blood pressure decrease of \>20 mmHg with symptoms
  • Hypertropic cardiomyopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bin Inam Rehabilitation Center.

Faisalābad, Punjab Province, 38000, Pakistan

Location

Related Publications (2)

  • George PM, Wells AU, Jenkins RG. Pulmonary fibrosis and COVID-19: the potential role for antifibrotic therapy. Lancet Respir Med. 2020 Aug;8(8):807-815. doi: 10.1016/S2213-2600(20)30225-3. Epub 2020 May 15.

    PMID: 32422178BACKGROUND

  • Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patients who survived hospitalisation. Eur Respir J. 2020 Oct 15;56(4):2002096. doi: 10.1183/13993003.02096-2020. Print 2020 Oct.

    PMID: 32764112BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ishtiaq Ahmed, DPT

    Government College University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 24, 2020

Study Start

July 3, 2020

Primary Completion

September 10, 2020

Study Completion

October 3, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)