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Effects of Telerehabilitation-based Exercises in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis, Exercise, Telerehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Istanbul Bilgi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring physiotherapy, cystic fibrosis, randomized controlled trial, telerehabilitation

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being diagnosed with cystic fibrosis
  • Being between the ages of 8-18
  • Having a device for video calls (phone, computer, tablet, etc.)

Exclusion Criteria:

  • Severe airway obstruction (FEV1 (%, predicted) <40%)
  • Pulmonary exacerbation/hospitalization in the last four weeks
  • History of lung transplant
  • Orthopedic problems that limit exercise
  • Those who had a change in their medical treatment during the study

Sites / Locations

  • Istanbul University-CerrahpasaRecruiting
  • Istanbul Bilgi UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group I

Group 2

Group 3

Arm Description

They will be individually included in exercise training with telerehabilitation (via Zoom application) for eight weeks. Exercise program includes: (F) 3 times a week, (I) at 60-70% of the maximum heart rate, (T): breathing, stretching, aerobic, plyometric, balance exercises, (T) 30 minutes each session, a total of 8 week. During the exercise sessions, the heart rate will be monitored via a Polar A370 Fitness Watch, and the oxygen saturations will be monitored with a pulse oximeter.

They will be individually included in exercise training with (via Zoom application) for eight weeks. Exercise program includes: (F) 3 times a week, (I) at 60-70% of the maximum heart rate, (T): breathing, stretching, aerobic, plyometric, balance exercises, (T) 30 minutes each session, a total of 8 week. During the exercise sessions, the heart rate will be monitored via a Polar A370 Fitness Watch, and the oxygen saturations will be monitored with a pulse oximeter.

They will continue their routine treatment (medical treatment, airway cleaning techniques, physical activity counseling).

Outcomes

Primary Outcome Measures

Functional exercise capacity
Six-minute walking test: Before the test, oxygen saturation, heart rate, blood pressure, dyspnea and fatigue measurements are recorded. The patient walks for six minutes as fast as they can walk on the ground for at least 30 meters. The walking distance is recorded in meters. If the patient stops during the test, the total time he stopped, the number of times he stopped is recorded. After the test, the evaluations made before the test are repeated.
Functional exercise capacity
Modified shuttle walking test: It is a maximal test performed by adjusting walking speed with pre-recorded signals. Before the test, oxygen saturation, heart rate and blood pressure, dyspnea and fatigue will be recorded. The patient walks between two 10-meter points. Walking speed is increased every minute. The test is terminated when the required speed cannot be maintained or the speed cannot be followed. At the end of the test, the measurements are repeated.

Secondary Outcome Measures

Muscle strength
For the peripheral muscle strength, the strength and grip strength of the knee extensor, hip flexor and abductor muscles in the lower extremity, and the elbow flexor, shoulder flexor and abductor muscles in the upper extremity will be examined. Measurement of muscle strength will be made with a Lafayette manual muscle tester, measurement of grip strength will be made with a Jamar hydraulic hand dynamometer. Evaluations will be made with the patient in a sitting position with back support. Evaluation of muscle strength will be done by evaluating the right and left extremities, and the grip strength will be repeated three times separately for the dominant hand and the non-dominant hand.
Spirometric measurements
The measured and predictive (%) values of FEV1, forced vital capacity (FVC), FEV1/FVC ratio, peak expiratory flow (PEF) will be recorded from the results of the pulmonary function test performed in accordance with the American Thoracic Society/European Respiratory Society guidelines.
Balance
Timed up and go test will use for balance assessment. The test, which starts with sitting in a chair, ends with walking a distance of three meters, turning and sitting on the chair again. The test completion time is recorded in seconds.
Anaerobic performance
The anaerobic performance of the patients will be evaluated with the vertical jump test. The vertical jump test is an indicator of lower extremity explosive strength. When the patient jumps as high as possible, the distance achieved by the jump is recorded in meters. The test is repeated three times and the best performance is recorded.
Health-related quality of life by questionnaire
The Pediatric Quality of Life Inventory (PedsQL) developed by Varni et al. will be used to evaluate the quality of life of the patients. The scale consists of 23 items in total. Eight of these items question physical, five emotional, five social, and five school functionality. The total score is calculated by scoring each item on a five-point Likert scale (0-4). The higher the score, the better the health-related quality of life.
Adherence rate
An exercise diary will be given to monitor the patients' daily routine physiotherapy (airway cleaning techniques, physical activity, etc.). Sessions will be logged by patients and their families. At the end of the treatment, the continuity of the routine treatment will be calculated as % with the equation "routine treatment sessions x 100/total days". A record of participation in telerehabilitation-based supervised exercise sessions will be recorded by the physiotherapist. When the training is over, the adherence rate will be calculated as % with the equation "exercise sessionsx100/24". A participation rate of 80 percent will be taken as a criterion for continuity.

Full Information

First Posted
October 16, 2022
Last Updated
August 4, 2023
Sponsor
Istanbul Bilgi University
Collaborators
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05590169
Brief Title
Effects of Telerehabilitation-based Exercises in Cystic Fibrosis
Official Title
Comparison of Effects of Telerehabilitation-based Individual and Group Exercises on Functional Capacity in Patients With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Bilgi University
Collaborators
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pulmonary rehabilitation programs are an important part of lifelong therapy in the treatment of patients with cystic fibrosis. Although the possible benefits of exercise are known, physical activity levels and participation in exercise are low in patients with cystic fibrosis. There are barriers such as lack of time, demoralization, lack of motivation, and transportation problems. Although group exercises are an approach that increases participation and motivation, it is not considered a very suitable method because it increases the risk of cross infection in patients with cystic fibrosis when performed face-to-face. Telerehabilitation programs, which are increasingly used in chronic respiratory diseases, show similar results with clinical rehabilitation programs. Telerehabilitation programs, the effects of which have been examined in different disease groups in recent years, on patients with cystic fibrosis are limited in the literature. Group exercises that can be given with the telerehabilitation method may be a good approach for patients with cystic fibrosis, eliminating possible infection transmission. The goal of this interventional clinical trial is to compare of effects of telerehabilitation based individual and group exercises on functional exercise capacity, muscle strength, respiratory functions, balance, anaerobic power, quality of life, and adherence in children with cystic fibrosis. The main question it aims to answer are: • Is there a difference between functional exercise capacity, muscle strength, respiratory functions, balance, anaerobic performance, quality of life and compliance with treatment between telerehabilitation based group exercises and telerehabilitation based individual exercises in patients with cystic fibrosis? Participants will be randomized into three groups: Group 1: They will be divided into groups of four and included in the exercise training for eight weeks with telerehabilitation. Group 2: They will be individually included in exercise training with telerehabilitation for eight weeks. Group 3 (control group): They will continue their routine treatment (medical treatment, airway cleaning techniques, physical activity counseling).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Exercise, Telerehabilitation, Exercise Capacity
Keywords
physiotherapy, cystic fibrosis, randomized controlled trial, telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
They will be individually included in exercise training with telerehabilitation (via Zoom application) for eight weeks. Exercise program includes: (F) 3 times a week, (I) at 60-70% of the maximum heart rate, (T): breathing, stretching, aerobic, plyometric, balance exercises, (T) 30 minutes each session, a total of 8 week. During the exercise sessions, the heart rate will be monitored via a Polar A370 Fitness Watch, and the oxygen saturations will be monitored with a pulse oximeter.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
They will be individually included in exercise training with (via Zoom application) for eight weeks. Exercise program includes: (F) 3 times a week, (I) at 60-70% of the maximum heart rate, (T): breathing, stretching, aerobic, plyometric, balance exercises, (T) 30 minutes each session, a total of 8 week. During the exercise sessions, the heart rate will be monitored via a Polar A370 Fitness Watch, and the oxygen saturations will be monitored with a pulse oximeter.
Arm Title
Group 3
Arm Type
No Intervention
Arm Description
They will continue their routine treatment (medical treatment, airway cleaning techniques, physical activity counseling).
Intervention Type
Other
Intervention Name(s)
Exercise training
Other Intervention Name(s)
Telerehabilitation-based exercise
Intervention Description
Group 1: Group exercises via Zoom application Group 2: Individual exercises via Zoom application Group 3: Routine treatment
Primary Outcome Measure Information:
Title
Functional exercise capacity
Description
Six-minute walking test: Before the test, oxygen saturation, heart rate, blood pressure, dyspnea and fatigue measurements are recorded. The patient walks for six minutes as fast as they can walk on the ground for at least 30 meters. The walking distance is recorded in meters. If the patient stops during the test, the total time he stopped, the number of times he stopped is recorded. After the test, the evaluations made before the test are repeated.
Time Frame
0-8 weeks
Title
Functional exercise capacity
Description
Modified shuttle walking test: It is a maximal test performed by adjusting walking speed with pre-recorded signals. Before the test, oxygen saturation, heart rate and blood pressure, dyspnea and fatigue will be recorded. The patient walks between two 10-meter points. Walking speed is increased every minute. The test is terminated when the required speed cannot be maintained or the speed cannot be followed. At the end of the test, the measurements are repeated.
Time Frame
0-8 weeks
Secondary Outcome Measure Information:
Title
Muscle strength
Description
For the peripheral muscle strength, the strength and grip strength of the knee extensor, hip flexor and abductor muscles in the lower extremity, and the elbow flexor, shoulder flexor and abductor muscles in the upper extremity will be examined. Measurement of muscle strength will be made with a Lafayette manual muscle tester, measurement of grip strength will be made with a Jamar hydraulic hand dynamometer. Evaluations will be made with the patient in a sitting position with back support. Evaluation of muscle strength will be done by evaluating the right and left extremities, and the grip strength will be repeated three times separately for the dominant hand and the non-dominant hand.
Time Frame
0-8 weeks
Title
Spirometric measurements
Description
The measured and predictive (%) values of FEV1, forced vital capacity (FVC), FEV1/FVC ratio, peak expiratory flow (PEF) will be recorded from the results of the pulmonary function test performed in accordance with the American Thoracic Society/European Respiratory Society guidelines.
Time Frame
0-8 weeks
Title
Balance
Description
Timed up and go test will use for balance assessment. The test, which starts with sitting in a chair, ends with walking a distance of three meters, turning and sitting on the chair again. The test completion time is recorded in seconds.
Time Frame
0-8 weeks
Title
Anaerobic performance
Description
The anaerobic performance of the patients will be evaluated with the vertical jump test. The vertical jump test is an indicator of lower extremity explosive strength. When the patient jumps as high as possible, the distance achieved by the jump is recorded in meters. The test is repeated three times and the best performance is recorded.
Time Frame
0-8 weeks
Title
Health-related quality of life by questionnaire
Description
The Pediatric Quality of Life Inventory (PedsQL) developed by Varni et al. will be used to evaluate the quality of life of the patients. The scale consists of 23 items in total. Eight of these items question physical, five emotional, five social, and five school functionality. The total score is calculated by scoring each item on a five-point Likert scale (0-4). The higher the score, the better the health-related quality of life.
Time Frame
0-8 weeks
Title
Adherence rate
Description
An exercise diary will be given to monitor the patients' daily routine physiotherapy (airway cleaning techniques, physical activity, etc.). Sessions will be logged by patients and their families. At the end of the treatment, the continuity of the routine treatment will be calculated as % with the equation "routine treatment sessions x 100/total days". A record of participation in telerehabilitation-based supervised exercise sessions will be recorded by the physiotherapist. When the training is over, the adherence rate will be calculated as % with the equation "exercise sessionsx100/24". A participation rate of 80 percent will be taken as a criterion for continuity.
Time Frame
When the exercise training is over (after eight weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being diagnosed with cystic fibrosis Being between the ages of 8-18 Having a device for video calls (phone, computer, tablet, etc.) Exclusion Criteria: Severe airway obstruction (FEV1 (%, predicted) <40%) Pulmonary exacerbation/hospitalization in the last four weeks History of lung transplant Orthopedic problems that limit exercise Those who had a change in their medical treatment during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cigdem Emirza, PT, MSc
Phone
+902123115136
Ext
5136
Email
cgdemrza@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Goksen Kuran Aslan, PT, phD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34500
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cigdem Emirza, PT, MSc
Phone
02123115136
Email
cgdemrza@gmail.com
Facility Name
Istanbul Bilgi University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cigdem Emirza, PT, MSc
Email
cigdem.emirza@bilgi.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30324099
Citation
Chen JJ, Cooper DM, Haddad F, Sladkey A, Nussbaum E, Radom-Aizik S. Tele-Exercise as a Promising Tool to Promote Exercise in Children With Cystic Fibrosis. Front Public Health. 2018 Sep 28;6:269. doi: 10.3389/fpubh.2018.00269. eCollection 2018.
Results Reference
background
PubMed Identifier
36193006
Citation
Stanford G, Daniels T, Brown C, Ferguson K, Prasad A, Agent P, Gates A, Morrison L. Role of the Physical Therapist in Cystic Fibrosis Care. Phys Ther. 2022 Dec 30;103(1):pzac136. doi: 10.1093/ptj/pzac136.
Results Reference
background
PubMed Identifier
33511633
Citation
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
Results Reference
background

Learn more about this trial

Effects of Telerehabilitation-based Exercises in Cystic Fibrosis

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