Telerehabilitation in Patients With Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06175039
• Other study ID #: BronsTeleReh-1
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: April 28, 2024

Study information

• Verified date: November 2023
• Source: Saglik Bilimleri Universitesi
• Contact: Busra Ocal, Master Degree Student
• Phone: +90 531 972 4398
• Email: bsra3198[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 28, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Other:
• Telerehabilitation exercise program
TRGr will be given online exercises, synchronized 3 days a week, accompanied by a physiotherapist, via videoconference on the group smartphone.
• Control program
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.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri University	Istanbul	Uskudar

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Forced vital capacity (FVC)	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	Change from baseline FVC at 8 weeks
Secondary	Forced expiratory volume in one second (FEV1)	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	Change from baseline FEV1 at 8 weeks
Secondary	Respiratory muscle strength	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.	Change from baseline respiratory muscle strength at 8 weeks
Secondary	Peripheral muscle strength	Peripheral muscle strength will be assessed by the hand held dynamometer	Change from baseline peripheral muscle strength at 8 weeks
Secondary	Perception of dyspnea	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.	Change from baseline dyspnea perception at 8 weeks
Secondary	Saint George Respiratory Questionnaire (SGRQ) score	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)	Change from baseline SGRQ score at 8 weeks
Secondary	Modified Borg Scale	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.	Change from baseline Modified Borg Scale score at 8 weeks
Secondary	Leicester Cough Questionnaire (LCQ)	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.	Change from baseline LCQ score at 8 weeks