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Recruiting NCT06756230

Downhill Walking in IPF

No phase Interventional Idiopathic Pulmonary Fibrosis (IPF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulmonary Rehabilitation, Downhill Walking, Treadmill Walking without incline.
Who it may be relevant to
Registry conditions: Idiopathic Pulmonary Fibrosis (IPF). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Pulmonary Rehabilitation
    8 weeks, 2 sessions per week, Aerobic training will be provided as treadmill walking. It will be performed either downhill or on a flat treadmill, depending on the group. Warm-up and stretching exercises Resistance exercises will be performed with a load equivalent to 50% of 1 maximum repetition. 10 repetitions will be performed in sets, one set in each session. Based on the differences in the general condition of the patients, different workloads and modifications will be used when creating
  • Other Downhill Walking
    Treadmill exercise will be applied for 30 minutes in the target heart rate range of 60-80% intensity. The target heart rate method will be used to determine the exercise intensity. Blood pressure, heart rate and Borg Perceived Exertion Scale scores will be monitored during the exercises. Downhill walking training will continue with a constant -10% incline.
  • Other Treadmill Walking without incline
    Treadmill exercise will be applied for 30 minutes in the target heart rate range of 60-80% intensity. The target heart rate method will be used to determine the exercise intensity. Blood pressure, heart rate and Borg Perceived Exertion Scale scores will be monitored during the exercises. Traditional walking training will initially involve walking with a neutral incline.

Primary outcome measures

  • 6 Minutes Walking Distance (6MWD) [Time frame: Baseline and the end of the 8 weeks exercise program]
  • Saint George Quality of life questionnaire [Time frame: Baseline and the end of the 8 weeks exercise program]
Secondary outcome measures (10)
  • Spirometric measurements (Forced vital capacity) [Time frame: Baseline and the end of the 8 weeks exercise program]
  • Spirometric measurements (First second forced expiratory volume) [Time frame: Baseline and the end of the 8 weeks exercise program]
  • Spirometric measurements (FEV1/FVC ratio) [Time frame: Baseline and the end of the 8 weeks exercise program]
  • Peripheral muscle strength [Time frame: Baseline and the end of the 8 weeks exercise program]
  • Hand grip strength [Time frame: Baseline and the end of the 8 weeks exercise program]
  • Modified Medical Research Council Dyspnea Score [Time frame: Baseline and the end of the 8 weeks exercise program]
  • Fatigue severity scale [Time frame: Baseline and the end of the 8 weeks exercise program]
  • Hospital anxiety depression scale (HADS) [Time frame: Baseline and the end of the 8 weeks exercise program]
  • Determination of blood lactate level [Time frame: Baseline and the end of the 8 weeks exercise program]
  • Carbon monoxide diffusion capacity [Time frame: Baseline and the end of the 8 weeks exercise program]

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 75.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Saglik Bilimleri Universitesi — Istanbul

Identifiers

NCT: NCT06756230 · Eccentric_IPF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗