Idiopathic Pulmonary Fibrosis (IPF)NCT06756230
Downhill Walking in IPF
A study testing Pulmonary Rehabilitation, Downhill Walking and Treadmill Walking without incline in people with Idiopathic Pulmonary Fibrosis (IPF), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- Pulmonary Rehabilitation, Downhill Walking and Treadmill Walking without incline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nisanur TUTUŞ contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Saglik Bilimleri Universitesi
Istanbul, Üsküdar, 34668
Esra Pehlivan, Associate Professor, 02164189616, fztesrakambur@yahoo.com
About this study
Official title: 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.
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.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- Pulmonary Rehabilitation, Downhill Walking, Treadmill Walking without incline
- Keywords
- IPF, eccentric exercise training, pulmonary rehabilitation
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
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 WalkingOther
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 inclineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pulmonary Rehabilitation; Other: Treadmill Walking without incline |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minutes Walking Distance (6MWD)
6 MWD means the distance the patient walked in 6 minute walk test. Its unit is meters.
Measured: 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).
Measured: Baseline and the end of the 8 weeks exercise program
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and the end of the 8 weeks exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start13 May 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA PEHLIVAN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756230
- Sponsor's protocol ID
- Eccentric_IPF
- Status last verified
- May 2025
- First submitted
- 25 Dec 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Downhill Walking in Pulmonary Rehabilitation for Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06756230
- Acronym / sponsor ID
- Eccentric_IPF
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- IPF, eccentric exercise training, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Downhill Walking PR Group | Active comparator | Other: Pulmonary Rehabilitation, Other: Downhill WalkingA standard pulmonary rehabilitation (PR) exercise program will be implemented. Downhill treadmill walking will be included during walking sessions. |
| Standard PR group | Active comparator | Other: Pulmonary Rehabilitation, Other: Treadmill Walking without inclineA standard pulmonary rehabilitation (PR) exercise program will be implemented. Walking will be performed on a treadmill without incline. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Rehabilitation8 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 PR Group, Standard PR group |
| Downhill WalkingTreadmill 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 | Downhill Walking PR Group |
| Treadmill Walking without inclineTreadmill 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. | Other | Standard PR group |
Primary outcome
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.
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).
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nisanur TUTUŞ contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation, Downhill Walking and Treadmill Walking without incline in people with Idiopathic Pulmonary Fibrosis (IPF), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra PEHLIVAN, Associate Professor (02164189616, fztesrakambur@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minutes Walking Distance (6MWD) (time frame: Baseline and the end of the 8 weeks exercise program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.