NCT04694729

Brief Summary

Pulmonary rehabilitation (PR) is a first-line management strategy in chronic obstructive pulmonary patients (COPD) as it reduces shortness of breath, increases exercise capacity, and improves health-related quality of life. However, 8-50% of patients referred to PR do not participate at all, while 10-32% of those who start do not complete the program. Barriers to participation and completion include difficulty in accessing the program, poor mobility, lack of transport, and travel costs. Telerehabilitation is defined as the provision of rehabilitation services through telecommunication technology, including telephone, internet and video conference communications between the patient and the healthcare provider. Different technologies (from phone to video conferencing) have been tested in patients with COPD to enhance daily activities, exercise training and walking prescription. All of them showed positive effects on exercise tolerance, dyspnea, physical activity and quality of life. However, there is no study about which telerehabilitation program is more effective on COPD patients. The aim of this study is to investigate which telerehabilitation approach is more effective in COPD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 2, 2021

Last Update Submit

January 4, 2021

Conditions

TelerehabilitationCOPD

Outcome Measures

Primary Outcomes (2)

  • 6 minute walk test(6MWT)

    6 week

  • Pulmonary function testing

    6 week

Secondary Outcomes (9)

  • 30-Second Chair Stand Test

    6 week

  • Time Up and Go Test

    6 week

  • Copd Assessment Test

    6 week

  • St George's Respiratory Questionnaire

    6 week

  • Hospital Anxiety and Depression Scale

    6 week

  • +4 more secondary outcomes

Study Arms (2)

study group

EXPERIMENTAL

Videoconference-based

Other: videoconference-based

control group

EXPERIMENTAL

Video-based

Other: video-based

Interventions

videoconference-basedOTHER

Exercises will be done 3 days a week for 6 weeks, with the help of a physiotherapist via video conference.

study group
video-basedOTHER

The exercise video will be sent to the patients and they will do it 3 days a week for 6 weeks. The subjects will be asked to keep an exercise diary and the status of the diaries will be followed by calling once a week.

control group

Eligibility Criteria

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

You may qualify if:

  • Being diagnosed with COPD (FEV1 / FVC \<70% in the stable phase of the disease)
  • Age \> 18 years old
  • Have the ability to use a smartphone

You may not qualify if:

  • Musculoskeletal disorders that limit exercise
  • Dizziness, significant sensory or motor impairments, dementia or terminal illnesses that prevent education
  • Serious comorbidities such as unstable heart disease, irregular diabetes, known malignant disease, any other disease that makes the patient unsuitable for participation in the study.
  • Incompatible patient
  • Severe vision or hearing impairment
  • Unwillingness or inability to follow the protocol
  • Have had a COPD exacerbation in the previous 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Nursima Bulut Physiotherapist

CONTACT

2163463636bltnursima@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

January 2, 2021

First Posted

January 5, 2021

Study Start

January 1, 2021

Primary Completion

March 1, 2021

Study Completion

December 1, 2021

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations

TU(1)