NCT03561818

Brief Summary

The investigators aimed to compare the home-based Pulmonary Rehabilitation with the hospital-based pulmonary rehabilitation in terms of pulmonary rehabilitation efficiency in patient with bronchiectasis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Jun 2018Dec 2026

First Submitted

Initial submission to the registry

May 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 19, 2018

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

8.5 years

First QC Date

May 14, 2018

Last Update Submit

April 29, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes from baseline the 6-minute walking distance at two months.

    Two months

  • Changes from baseline the modified Medical Research Council (mMRC) scale at two months.

    Dyspnea perceptions during daily life activities will assess according to the modified Medical Research Council (mMRC) scale. The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "0" means no dyspnea perception, "4" means severe dyspnea perception.

    Two months

Secondary Outcomes (3)

  • Changes from baseline the forced expiratory volume in one second at two months.

    Two months

  • Changes from baseline the peripheral muscle strength at two months.

    Two months

  • Changes from baseline the Quality of Life at two months.

    Two months

Study Arms (2)

Hospital-based group

EXPERIMENTAL

2 months hospital-based pulmonary rehabilitation program

Other: Hospital-based pulmonary rehabilitation

Home-based group

EXPERIMENTAL

2 months home-based pulmonary rehabilitation program

Other: Home-based pulmonary rehabilitation

Interventions

The patients who undergo two days pulmonary rehabilitation under supervision in our clinic and three days a week at home during two months will taken as hospital group. The exercises include breathing exercises, treadmill (15sc), cycle training (15sc), arm ergometer training (15sc), peripheral muscle training and stretching exercises with free weights.

Hospital-based group

The patients who follow a home-based pulmonary rehabilitation program for two months comprising breathing exercises, training in chest hygiene techniques, peripheral muscle strengthening training and self-walking for 5 days in a week for two months. An exercise follow-up form will give to the patients to record their daily exercises. A similar form will fill by physiotherapist once a week during phone call.

Home-based group

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 18-70
  • Patients signing informed consent form
  • Bronchiectasis patients in the stable phase who were diagnosed with High-resolution computed tomography (HRCT).

You may not qualify if:

  • Decompensated heart failure, uncontrolled hypertension (Systolic Blood Pressure\> 200, Diastolic Blood Pressure\> 110),
  • Additional diseases that may prevent exercise,
  • To be regularly exercising regularly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

BronchiectasisLung DiseasesLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Central Study Contacts

Esra Pehlivan, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 14, 2018

First Posted

June 19, 2018

Study Start

June 19, 2018

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations