NCT05787353

Brief Summary

The purpose of this RETROSPECTIVE study was to compare the effect of a hospital and home-based cardiopulmonary rehabilitation (CPR) program on exercise endurance and quality of life in post-acute COVID-19 patients. 88 post-acute COVID-19 patients were divided two groups according to receiving hospital (n=45) or home-based CPR (n=43)in our rehabilitation clinic between January and July 2021. Both protocols consisted of aerobic, breathing and flexibility exercises. Hospital-based CPR: three or four days per week for a total of 20 sessions. Home-based CPR: three or four days/a week over a period of six weeks. The results of six meters walk test (6MWT) for exercise endurance as a main outcome measure, and Borg-dyspnea/fatigue, the visual analog scale (VAS) for pain and the Short Form-36 (SF-36) as secondary outcome measures before and after treatment were recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 16, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2021

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

March 24, 2023

Last Update Submit

March 28, 2023

Conditions

Cardiopulmonary

Outcome Measures

Primary Outcomes (1)

  • Exercise endurance

    Six minutes walk test (All patients walked along a 30-meter-long corridor without obstacles at their normal walking speed, how many meters they walked was noted.)

    One day before exercise programme start and one day later exercise programme ends

Secondary Outcomes (4)

  • Dyspnea

    One day before exercise programme start and one day later exercise programme ends

  • Muscle fatigue

    One day before exercise programme start and one day later exercise programme ends

  • short form 36

    One day before exercise programme start and one day later exercise programme ends

  • Musculoskeletal Pain

    One day before exercise programme start and one day later exercise programme ends

Study Arms (2)

Home based cardiopulmonary rehabilitation group

EXPERIMENTAL

This was a retrospective study. 43 patients who had home based cardiopulmonary rehabilitation programme between January and July 2023, in our rehabilitation clinic.

Other: Exercise programme

Hospital based cardiopulmonary rehabilitation group

EXPERIMENTAL

This was a retrospective study. 45 patients who had hospital based cardiopulmonary rehabilitation programme between January and July 2023, in our rehabilitation clinic.

Other: Exercise programme

Interventions

Exercise programmeOTHER

Both protocols consisted of aerobic, breathing and flexibility exercises. Hospital-based CPR: three or four days per week for a total of 20 sessions. Home-based CPR: three or four days/a week over a period of six weeks.

Home based cardiopulmonary rehabilitation groupHospital based cardiopulmonary rehabilitation group

Eligibility Criteria

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

You may qualify if:

  • being 18 years or older
  • having COVID-19 treatment (home quarantine/hospital/intensive care unit) according to a positive polymerase chain reaction (PCR) test in a nasopharyngeal + oropharyngeal swab or chest computed tomography (CT)
  • participating in a home-based exercise program (for 6 weeks) or hospital-based CPR (for 12-20 sessions) due to post-acute COVID-19 symptoms (fatigue, myalgia, dyspnea).

You may not qualify if:

  • Patients who had both a negative PCR test and chest CT
  • Patients who had not completed the six minute walk test (6MWT), Borg scales, Short Form-36 and Visual analog scale-pain.
  • Acute COVID-19 patients (patients whose symptoms had started less than one month previous)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, Odunpazarı, Turkey (Türkiye)

Location

Study Officials

  • Fulya Bakılan, Assoc. Prof.

    Eskişehir Osmangazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2023

First Posted

March 28, 2023

Study Start

April 16, 2021

Primary Completion

July 25, 2021

Study Completion

July 31, 2021

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)