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NCT Number: NCT06756230

Downhill Walking in IPF

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saglik Bilimleri Universitesi

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location status: Recruiting

Location contact

Esra Pehlivan, Associate Professor

CONTACT

[email protected]

02164189616

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary Rehabilitation

Other

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.

Downhill Walking

Other

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.

Treadmill Walking without incline

Other

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 outcomes

  1. 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.

  2. 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

  1. Spirometric measurements (Forced vital capacity)

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

    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.

  2. Spirometric measurements (First second forced expiratory volume)

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

    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.

  3. Spirometric measurements (FEV1/FVC ratio)

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

    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.

  4. Peripheral muscle strength

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

    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.

  5. Hand grip strength

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

    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.

  6. Modified Medical Research Council Dyspnea Score

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

    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.

  7. Fatigue severity scale

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

    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.

  8. Hospital anxiety depression scale (HADS)

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

    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.

  9. Determination of blood lactate level

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

    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.

  10. Carbon monoxide diffusion capacity

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esra PEHLIVAN, Associate Professor

CONTACT

[email protected]

02164189616

Nisanur TUTUŞ

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 1, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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