NCT06175039

Brief Summary

It is to determine the effectiveness of pulmonary rehabilitation by telerehabilitation method in bronchiectasis patients. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TRGr) and Control Group (CGr).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

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

May 15, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2024

Completed
Last Updated

June 7, 2024

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

November 23, 2023

Last Update Submit

June 6, 2024

Conditions

Keywords

bronchiectasispulmonary rehabilitationtelerehabilitation

Outcome Measures

Primary Outcomes (1)

  • The exercise capacity

    The exercise capacity will be assessed by the incremental shuttle walking test.

    Change from baseline incremental shuttle walking distance at 8 weeks

Secondary Outcomes (8)

  • Forced vital capacity (FVC)

    Change from baseline FVC at 8 weeks

  • Forced expiratory volume in one second (FEV1)

    Change from baseline FEV1 at 8 weeks

  • Respiratory muscle strength

    Change from baseline respiratory muscle strength at 8 weeks

  • Peripheral muscle strength

    Change from baseline peripheral muscle strength at 8 weeks

  • Perception of dyspnea

    Change from baseline dyspnea perception at 8 weeks

  • +3 more secondary outcomes

Study Arms (2)

Telerehabilitation Exercise Group

EXPERIMENTAL
Other: Telerehabilitation exercise program

Control Group

OTHER
Other: Control program

Interventions

TRGr will be given online exercises, synchronized 3 days a week, accompanied by a physiotherapist, via videoconference on the group smartphone.

Telerehabilitation Exercise Group

KGr will be a pulmonary rehabilitation information brochure will be given after the initial evaluation. They will be asked to do the exercises on the brochure.

Control Group

Eligibility Criteria

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

You may qualify if:

  • Aged 18 and over
  • Diagnosed with bronchiectasis by HRCT
  • Stable clinical state at the time of admission without infection or exacerbation in the previous 3 weeks
  • Know how to use technological devices

You may not qualify if:

  • A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training
  • Patients with systemic diseases other than bronchiectasis that also affect the lungs, such as systemic lupus erythematosus, infection, interstitial lung disease, lung cancer, heart and kidney failure, which will cause shortness of breath
  • Having balance problems that prevent them from doing exercises
  • Participation in a pulmonary rehabilitation program within the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri University

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Esra Pehlivan, Assoc.Prof.Dr.

    Advisor

    PRINCIPAL INVESTIGATOR
  • Busra Ocal, Master Degree Student

    Student

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TRGr) and Control Group (KGr).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 18, 2023

Study Start

May 15, 2023

Primary Completion

March 16, 2024

Study Completion

June 4, 2024

Last Updated

June 7, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations