NCT06303479

Brief Summary

It is a prospective randomized controlled trial. In this project, it is aimed to examine the effect of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on lung capacities. For this reason;

  • Contributing to the literature by comparing the effect of breathing exercises with and without instruments on lung capacities,
  • It is aimed to be a resource for the effective use of respiratory exercise, which has a high effect on lung capacities, in treatment. In addition, with the data obtained, it is aimed to decide and apply the exercise that is more effective in the treatment of respiratory diseases quickly. Socio-demographic data will be questioned by using the Demographic Data Form; participants, age, gender, height, weight, marital status, smoking and alcohol use, presence of disease, whether they are included in a different exercise program, dyspnea, severe nausea and vomiting. The cases will be randomized into two groups: non-instrumented breathing exercises group and instrumented breathing exercises group. The physical activity status of the individuals participating in the study will be questioned using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at the beginning and end of the study. Pulmonary Function Test (PFT) will be used to measure the lung capacity of the participants. Instrumented breathing exercises will be performed for 8 weeks, 2 days a week with the telerehabilitation program, 3 days a week as a home program, 5 days a week in total, starting with 1 set of 15 repetitions and the program will progress with progression. Diaphragmatic breathing and thoracic extension exercises will be applied as non-instrumented breathing exercises. For 8 weeks, 2 days a week with telerehabilitation method, 3 days a week as a home program, 5 days a week in total, 1 set of 10 repetitions for each exercise and the program will progress with progression. At the end of 8 weeks, all evaluations of the participants in both groups will be repeated.

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
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 26, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2024

Completed
Last Updated

March 12, 2024

Status Verified

December 1, 2023

Enrollment Period

1 month

First QC Date

February 26, 2024

Last Update Submit

March 6, 2024

Conditions

Keywords

spirometryphysical activitylung volume

Outcome Measures

Primary Outcomes (4)

  • Pulmonary Function Test for FEV1

    Pulmonary function test will be performed with desktop type spirometry. The FEV1 value will be calculated.

    At baseline and 8 weeks

  • Pulmonary Function Test for PEF

    Pulmonary function test will be performed with desktop type spirometry. The PEF value will be calculated.

    At baseline and 8 weeks

  • Pulmonary Function Test for FEV1/FVC

    Pulmonary function test will be performed with desktop type spirometry. The FEV1/FVC value will be calculated.

    At baseline and 8 weeks

  • Pulmonary Function Test for FVC

    Pulmonary function test will be performed with desktop type spirometry. The FVC value will be calculated.

    At baseline and 8 weeks

Secondary Outcomes (1)

  • International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    At baseline and 8 weeks

Study Arms (2)

Instrumental breathing exercise group

EXPERIMENTAL

Instrumental breathing exercise group consisting of 13 healthy adults between the ages of 18-30

Other: Instrumental breathing exercise group

Non-Instrumental breathing exercise group

EXPERIMENTAL

Non-Instrumental breathing exercise group consisting of 13 healthy adults between the ages of 18-30

Other: Non-Instrumental breathing exercise group

Interventions

Before starting the exercises, participants will be told about diaphragmatic breathing exercises, maximum inspiratory holding technique and thoracic expansion exercises through the Zoom program by telerehabilitation method, and people will be checked by the physiotherapist who manages the program during the practice. The program will last for 8 weeks and will be planned to be implemented 5 days a week in total, including 2 days of telerehabilitation, 3 days of home program. The participant will be asked to start the exercises in a reclining position with his back to the chair. He will be asked to place his right hand on his upper abdomen and his left hand on the upper side of his chest. In each session, the exercises will be performed with 1 set of 10 repetitions for each of the diaphragmatic breathing and thoracic expansion exercises and will progress with progression.

Non-Instrumental breathing exercise group

The volume-oriented spirometer works with pressure and its indicator changes during breathing. When the participants breathe, the pressure in the tube decreases and the piston of the spirometer rises. The inhaled breath volume is seen at the top of the piston. In our study, participants will be told about the exercises through the Zoom program using the telerehabilitation method, and people will be checked by the responsible physiotherapist who manages the program during the application. The program will last for 8 weeks, 2 days of telerehabilitation, 3 days of home program will be planned to be implemented 5 days a week in total. Participants will be instructed to breathe up to their total lung capacity and maintain continuous inspiration for at least 3 seconds. The exercises will start with 1 set of 15 repetitions and the program will progress with progression.

Instrumental breathing exercise group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female/male young adult between the ages of 18-30 December,
  • Who volunteered to participate in the study,
  • Without a known disease
  • Volunteers who do not have psychological, cognitive and emotional problems

You may not qualify if:

  • Cigarette and alcohol users
  • People with severe cardiopulmonary disorders
  • People with postural disorders (such as scoliosis,kyphosis...)
  • Unstable angina, has it been recently, pulmonary embolism
  • People with obesity/diabetes
  • Mental or cognitive impairment that will affect mental cooperation
  • People with severe nausea, vomiting attacks
  • People with dyspnea
  • People with orthopedic disorders that will affect exercise performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Fatma Nur AYYILDIZ, Student

    Saglik Bilimleri Universitesi

    STUDY CHAIR
  • Beyzanur YEŞİLYURT, Student

    Saglik Bilimleri Universitesi

    STUDY CHAIR
  • Fulya KARAAHMETOĞLU, PhD (c)

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Central Study Contacts

Mustafa ÇÖRTÜK, Prof.Dr.

CONTACT

Esra PEHLİVAN, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 12, 2024

Study Start

April 1, 2024

Primary Completion

May 1, 2024

Study Completion

September 29, 2024

Last Updated

March 12, 2024

Record last verified: 2023-12

Locations