Downhill Walking in IPF

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

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Other: Pulmonary Rehabilitation; Other: Downhill Walking; Other: Treadmill Walking without incline

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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esra Pehlivan, Associate Professor; Phone Number: 02164189616; Email: fztesrakambur@yahoo.com
• Study Contact Backup: Name: Nisanur TUTUŞ; Email: nisanurrtutus@gmail.com

Study Locations

• Turkey
  • Üsküdar
    • İstanbul, Üsküdar, Turkey, 34668
      • Recruiting
      • Saglik Bilimleri Universitesi
      • Contact: Esra Pehlivan, Associate Professor; Phone Number: 02164189616; Email: fztesrakambur@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; 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.
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; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minutes Walking Distance (6MWD)	6 MWD means the distance the patient walked in 6 minute walk test. Its unit is meters.	Baseline and the end of the 8 weeks exercise program
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).	Baseline and the end of the 8 weeks exercise program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and the end of the 8 weeks exercise program
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.	Baseline and the end of the 8 weeks exercise program
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.	Baseline and the end of the 8 weeks exercise program
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.	Baseline and the end of the 8 weeks exercise program
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.	Baseline and the end of the 8 weeks exercise program
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.	Baseline and the end of the 8 weeks exercise program
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.	Baseline and the end of the 8 weeks exercise program
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.	Baseline and the end of the 8 weeks exercise program
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.	Baseline and the end of the 8 weeks exercise program
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.	Baseline and the end of the 8 weeks exercise program

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: December 25, 2024
• First Submitted That Met QC Criteria: December 25, 2024
• First Posted (Actual): January 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation; IPF; eccentric exercise training
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
• Other Study ID Numbers: Eccentric_IPF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No