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RecruitingNCT06756230Updated May 16, 2025

Downhill Walking in IPF

An interventional study of Pulmonary Rehabilitation and Downhill Walking in Idiopathic Pulmonary Fibrosis (IPF), sponsored by Saglik Bilimleri Universitesi. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis (IPF)

Keywords

  • IPF
  • eccentric exercise training
  • pulmonary rehabilitation
03

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's planned enrollment of 34 is below the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 430 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
34 participants (estimated)

Study arms

  • Active comparator
    Downhill Walking PR Group

    A standard pulmonary rehabilitation (PR) exercise program will be implemented. Downhill treadmill walking will be included during walking sessions.

    Other: Pulmonary Rehabilitation · Other: Downhill Walking

  • Active comparator
    Standard PR group

    A standard pulmonary rehabilitation (PR) exercise program will be implemented. Walking will be performed on a treadmill without incline.

    Other: Pulmonary Rehabilitation · Other: Treadmill Walking without incline

Interventions

  • OtherPulmonary 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 an exercise program for each patient. Resistance exercises will focus on both upper and lower extremity muscles.

  • OtherDownhill 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.

  • OtherTreadmill 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.

06

What researchers measure

Primary outcomes

  1. 6 Minutes Walking Distance (6MWD)

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

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

  2. Saint George Quality of life questionnaire

    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).

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

Secondary outcomes

  1. Spirometric measurements (Forced vital capacity)

    It is used to evaluate respiratory functions. It is evaluated with a spirometer. Forced vital capacity (FVC): the maximum amount of air that can be forcibly exhaled from the lungs after fully inhaling. It can be recorded in percentages or liters.

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

  2. Spirometric measurements (First second forced expiratory volume)

    It is used to evaluate respiratory functions. It is evaluated with a spirometer. First-second forced expiratory volume (FEV1): the amount of air that can be exhaled with force in 1 second. It can be recorded in percentages or liters.

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

  3. Spirometric measurements (FEV1/FVC ratio)

    It is used to evaluate respiratory functions. It is evaluated with a spirometer. It is calculated by dividing FEV1 by FVC. It is expressed as a percentage.

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

  4. Peripheral muscle strength

    Peripheral muscle strength will be assessed using a digital dynamometer. Quadriceps femoris muscle strength; will be measured by applying maximum resistance 2-3 cm above the ankle malleolus of the patients in a sitting position using an digital dynamometer.

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

  5. Hand grip strength

    Hand grip strength will be assessed in a sitting position. During the test, the arm will be measured next to the body, with the shoulder adducted, the elbows flexed at 90°, the forearm and wrist in a neutral position, and patients will be asked to grip and release the dynamometer as strongly as possible, and the measurement will be repeated 3 times on both dominant and non-dominant extremities and the averages will be recorded. A one-minute rest will be given between each trial.

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

  6. Modified Medical Research Council Dyspnea Score

    Modified Medical Council Dyspnea score will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.

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

  7. Fatigue severity scale

    Fatigue levels of individuals will be assessed with the Fatigue Severity Scale (FSS). The FSS consists of 9 questions scored using a 7-point Likert scale, indicating a perception of fatigue that may require medical intervention.

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

  8. Hospital anxiety depression scale (HADS)

    A scale consisting of 14 items developed by Zigmond and Snaith. Seven of these items evaluate anxiety symptoms and seven evaluate depression symptoms. The items in the scale are evaluated with a 4-point Likert scale and are based on a scoring system between 0-3.

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

  9. Determination of blood lactate level

    Blood lactate level will be measured by fingertip sample using a portable lactate meter after a standardized exercise protocol applied before and after the intervention. Blood samples will be recorded in mmol/L after being analyzed by the device.

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

  10. Carbon monoxide diffusion capacity

    Carbon monoxide diffusion capacity (DLCO) is the measurement of the passage of carbon monoxide gas in inspired air into the lung capillary blood. Diffusion test is performed in the pulmonary function test laboratory.

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

07

Study locations

1 of 1 sites recruiting
  • Saglik Bilimleri Universitesi
    İstanbul, Üsküdar 34668, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06756230
Lead sponsor
Saglik Bilimleri Universitesi
Responsible party
ESRA PEHLIVAN (Associate Professor, Saglik Bilimleri Universitesi) — Principal investigator
First posted
Jan 1, 2025
Start date
May 13, 2025
Primary completion
Feb 28, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
May 16, 2025

Study contacts

Esra PEHLIVAN, Associate Professor
Contact
fztesrakambur@yahoo.com
02164189616
Nisanur TUTUŞ
Contact
nisanurrtutus@gmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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