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Completed

NCT Number: NCT06175039

Telerehabilitation in Patients With Bronchiectasis

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).

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saglik Bilimleri University

Istanbul, Uskudar, 34668, Turkey (Türkiye)

About this study

Patients diagnosed with bronchiectasis by HRCT by a chest diseases specialist and referred to pulmonary rehabilitation by determining the severity of bronchiectasis with the Modified Reiff Score and Bronchiectasis Severity Index Score will be included in the study.

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). TRGr will be given online exercises, synchronized 3 days a week, accompanied by a physiotherapist, via videoconference on the group smartphone. As for the KGr group, a pulmonary rehabilitation information brochure will be given to after the initial evaluation. They will be asked to do the exercises on the brochure. The exercise period will be 8 weeks for both groups. Standard medical treatments for both groups will continue.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Telerehabilitation exercise program

Other

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

Control Program

Other

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.

Primary outcomes

  1. The exercise capacity

    Time frame: Change from baseline incremental shuttle walking distance at 8 weeks

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

Secondary outcomes

  1. Forced vital capacity (FVC)

    Time frame: Change from baseline FVC at 8 weeks

    Forced vital capacity will be assessed by the spirometer. Pulmonary function test will performe by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines

  2. Forced expiratory volume in one second (FEV1)

    Time frame: Change from baseline FEV1 at 8 weeks

    Forced expiratory volume in one second will be assessed by the spirometer. Pulmonary function test will performe by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines

  3. Respiratory muscle strength

    Time frame: Change from baseline respiratory muscle strength at 8 weeks

    Respiratory muscle strength will be evaluated by the intraoral pressure measurement device.The mouth pressure measurement was performed with the Cosmed Pony Fx. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated five times. Verbal or visual feedback was provided after each maneuver. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value was obtained.

  4. Peripheral muscle strength

    Time frame: Change from baseline peripheral muscle strength at 8 weeks

    Peripheral muscle strength will be assessed by the hand held dynamometer

  5. Perception of dyspnea

    Time frame: Change from baseline dyspnea perception at 8 weeks

    Perception of dyspnea will be evaluated by Modified Medical Research Council Dyspnea 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. "O" means no dyspnea perception, "4" means severe dyspnea perception.

  6. Saint George Respiratory Questionnaire (SGRQ) score

    Time frame: Change from baseline SGRQ score at 8 weeks

    The quality of life will be assessed by the Saint George Respiratory Questionnaire.The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)

  7. Modified Borg Scale

    Time frame: Change from baseline Modified Borg Scale score at 8 weeks

    Exertion and rest define the level of dyspnea. It consists of ten items that describe the severity of dyspnea according to its degree. A minimum of 1 and a maximum of 10 points can be obtained. 1, no shortness of breath. 10, maximal shortness of breath.

  8. Leicester Cough Questıonnaıre (LCQ)

    Time frame: Change from baseline LCQ score at 8 weeks

    The cough will be assessed by the Leicester Cough Questionnaire. It includes physical, psychological and social sub-parameters and each item is scored between 1-7. High scores indicate that the cough is less affected, while low scores indicate that the cough is more affected.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Investigation of the Efficiency of Pulmonary Rehabilitation With Telerehabilitation Method in Patients With Bronchiectasis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2023
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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