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Clinical Trials/NCT06756230
NCT06756230
Recruiting
Not Applicable

Effects of Downhill Walking in Pulmonary Rehabilitation for Patients With Idiopathic Pulmonary Fibrosis

Saglik Bilimleri Universitesi1 site in 1 country34 target enrollmentMay 13, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Idiopathic Pulmonary Fibrosis (IPF)
Sponsor
Saglik Bilimleri Universitesi
Enrollment
34
Locations
1
Primary Endpoint
6 Minutes Walking Distance (6MWD)
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

In this study; will examine the effects of downhill walking (eccentric exercise training) on exercise capacity, quality of life, and blood lactate levels in individuals with IPF. After the initial assessment, patients will be randomized into two groups: downhill walking PR group and Standard PR Group.

Detailed Description

Individuals diagnosed with idiopathic pulmonary fibrosis who come to the Pulmonary Rehabilitation Unit of Istanbul Süreyyapaşa Chest Diseases and Chest Surgery Education and Research Hospital will be included in this study. Those who meet the inclusion criteria will be randomized into two groups: Downhill Walking Pr Group (n=17) and Standard Pr Group (n=17). Patients will have exercise sessions twice a week for 8 weeks. Patients will be evaluated immediately before the rehabilitation program and the end of 8 weeks exercise programme. In our study, downhill walking training will differ from traditional walking training only in terms of treadmill training protocol. Traditional walking training involves walking on a motorized treadmill with a neutral incline, progressing with increases in speed, while downhill walking training will be performed at a constant -10% incline.

Registry
clinicaltrials.gov
Start Date
May 13, 2025
End Date
February 28, 2027
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ESRA PEHLIVAN

Associate Professor

Saglik Bilimleri Universitesi

Eligibility Criteria

Inclusion Criteria

  • Having a diagnosis of IPF according to the clinical diagnostic criteria of the American Thoracic Society and/or the European Respiratory Society (ATS-ERS).
  • Being between the ages of 18 and
  • Being able to walk on a treadmill.
  • Having the ability to cooperate.
  • No change in current medication in the last month.
  • Not participating in a structured activity program for at least six months.
  • Accepting the purpose and method of this study voluntarily and give informed consent for the study.

Exclusion Criteria

  • Presence of physical or mental impairment that prevents informed consent or compliance with the protocol.
  • Inability to attend more than 20% of pulmonary rehabilitation sessions.
  • Presence of major cardiovascular disease (coronary artery disease, uncontrolled hypertension, arrhythmias, or heart failure).
  • Presence of existing orthopedic and neuromuscular exercise limitations.
  • Acute exacerbation

Outcomes

Primary Outcomes

6 Minutes Walking Distance (6MWD)

Time Frame: Baseline and the end of the 8 weeks exercise program

6 MWD means the distance the patient walked in 6 minute walk test. Its unit is meters.

Saint George Quality of life questionnaire

Time Frame: Baseline and the end of the 8 weeks exercise program

The St. George's Respiratory Questionnaire (SGRQ) is designed to measure quality of life. Four scores are calculated Symptoms, Activity, Impacts, and Total. Saint George Respiratory Questionaire (SGRQ) score: The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).

Secondary Outcomes

  • Spirometric measurements (Forced vital capacity)(Baseline and the end of the 8 weeks exercise program)
  • Spirometric measurements (First second forced expiratory volume)(Baseline and the end of the 8 weeks exercise program)
  • Spirometric measurements (FEV1/FVC ratio)(Baseline and the end of the 8 weeks exercise program)
  • Peripheral muscle strength(Baseline and the end of the 8 weeks exercise program)
  • Hand grip strength(Baseline and the end of the 8 weeks exercise program)
  • Modified Medical Research Council Dyspnea Score(Baseline and the end of the 8 weeks exercise program)
  • Fatigue severity scale(Baseline and the end of the 8 weeks exercise program)
  • Hospital anxiety depression scale (HADS)(Baseline and the end of the 8 weeks exercise program)
  • Determination of blood lactate level(Baseline and the end of the 8 weeks exercise program)
  • Carbon monoxide diffusion capacity(Baseline and the end of the 8 weeks exercise program)

Study Sites (1)

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