Downhill Walking in IPF

NCT06756230 | Recruiting

• 1 other identifier: Eccentric_IPF
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Keywords

IPF; eccentric exercise training; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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

Study Arms (2)

Downhill Walking PR Group

ACTIVE COMPARATOR

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

Standard PR group

ACTIVE COMPARATOR

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

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 PR Group; Standard PR group

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.

Downhill Walking PR Group

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.

Standard PR group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Esra PEHLIVAN, Associate Professor

CONTACT

02164189616; fztesrakambur@yahoo.com

Nisanur TUTUŞ

CONTACT

nisanurrtutus@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 1, 2025
• Study Start: May 13, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)