NCT05778344

Brief Summary

The aim of this study was to investigate the efficacy of a home-based pulmonary rehabilitation program with the support of teletechnology in COVID-19 survivors. The main questions it aims to answer were:

  • The change of six-minute walk distance
  • The change of time of one-minute sit-to-stand test
  • The change of maximal strength of upper-limb, lower-limb and respiratory muscle
  • The change of quality of life Participants in the home-based pulmonary rehabilitation group received teletechnology-assisted consultations (either by videotelephony or telephone calls) for every 1-2 weeks during the intervention period, and participants in the usual care group did not receive teletechnology-assisted consultations during the intervention period.

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 Apr 2023

Typical duration 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

March 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

April 12, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2024

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

March 13, 2023

Last Update Submit

September 4, 2025

Conditions

Keywords

Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (5)

  • Six-minute walk distance

    The distance of six-minute walk test

    Week 0

  • Six-minute walk distance

    The distance of six-minute walk test

    Week 4

  • Six-minute walk distance

    The distance of six-minute walk test

    Week 8

  • Six-minute walk distance

    The distance of six-minute walk test

    Week 12

  • Six-minute walk distance

    The distance of six-minute walk test

    Week 24

Secondary Outcomes (20)

  • Maximal upper limb strength

    Week 0

  • Maximal upper limb strength

    Week 4

  • Maximal upper limb strength

    Week 8

  • Maximal upper limb strength

    Week 12

  • Maximal upper limb strength

    Week 24

  • +15 more secondary outcomes

Study Arms (2)

Home-based pulmonary rehabilitation group

EXPERIMENTAL

The home-based pulmonary rehabilitation group received breathing exercise instructions using online learning materials soon after randomization. The participants received a home-based exercise plan, which comprised aerobic exercise and resistance exercise with instruction sheets. Teletechnology was incorporated into home-based pulmonary rehabilitation via videotelephony (or telephone calls if indicated). Time points for these teletechnology-assisted consultations were at day 7, day 14 after randomization and every 2 weeks after that until the completion of the study (week 12).

Behavioral: Teletechnology-assisted home-based pulmonary rehabilitation

Usual care group

ACTIVE COMPARATOR

The usual care group will receive breathing exercise instructions using online learning materials soon after randomization. The participants will also receive general exercise education and exercise safety principles but not any consultation about their physical activity/exercise during the study period.

Behavioral: Teletechnology-assisted home-based pulmonary rehabilitation

Interventions

The accuracy and safety of home-based pulmonary rehabilitation will be checked regularly through technology devices such as smart watch and via videotelephony (or telephone calls if indicated).

Home-based pulmonary rehabilitation groupUsual care group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are 20 years or more with severe (severe pneumonia) to critical (acute respiratory distress syndrome, sepsis, or septic shock) COVID-19 during hospitalization after deisolation.
  • Patients are 65 years or more, or ever receiving oral antiviral treatment after deisolation.
  • Patient have the ability to ambulate on level surface without direct contact of another person, have telecommunication device(s), and provide consent to receive teletechnology-assisted rehabilitation.

You may not qualify if:

  • Patients are pregnant or planning for pregnancy.
  • Patients have cognitive dysfunction, learning disability, uncontrolled arrhythmia or hypertension, or any medical diagnosis other than COVID-19 that would prominently influence their ability to follow instructions and perform exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (3)

  • Felten-Barentsz KM, van Oorsouw R, Klooster E, Koenders N, Driehuis F, Hulzebos EHJ, van der Schaaf M, Hoogeboom TJ, van der Wees PJ. Recommendations for Hospital-Based Physical Therapists Managing Patients With COVID-19. Phys Ther. 2020 Aug 31;100(9):1444-1457. doi: 10.1093/ptj/pzaa114.

    PMID: 32556323BACKGROUND
  • Gloeckl R, Leitl D, Jarosch I, Schneeberger T, Nell C, Stenzel N, Vogelmeier CF, Kenn K, Koczulla AR. Benefits of pulmonary rehabilitation in COVID-19: a prospective observational cohort study. ERJ Open Res. 2021 May 31;7(2):00108-2021. doi: 10.1183/23120541.00108-2021. eCollection 2021 Apr.

    PMID: 34095290BACKGROUND
  • Betschart M, Rezek S, Unger I, Beyer S, Gisi D, Shannon H, Sieber C. Feasibility of an Outpatient Training Program after COVID-19. Int J Environ Res Public Health. 2021 Apr 9;18(8):3978. doi: 10.3390/ijerph18083978.

    PMID: 33918887BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ping-Lun Hsieh

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr. Ping-Lun Hsieh

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 21, 2023

Study Start

April 12, 2023

Primary Completion

May 24, 2024

Study Completion

May 24, 2024

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations