Idiopathic Pulmonary FibrosisNCT03890250
Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis
A study testing Aerobic exercise and Neuromuscular electrical stimulation in people with Idiopathic Pulmonary Fibrosis and Neuromuscular Electrical Stimulation, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Pulmonary rehabilitation should be initiated and lifelong at the time of diagnosis for patients with IPF. However, the symptoms of the disease and its progression limit clinical options in terms of participation and sustainability in rehabilitation programs. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Neuromuscular Electrical Stimulation
- What is being tested?
- Aerobic exercise and Neuromuscular electrical stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2019to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of IPF according to current ATS / ERS guidelines has been followed by a pulmonary specialist for at least 6 months
- Patients who are clinically stable, have no flare or infection.
Who cannot join
- Orthopedic and neurological problems that may interfere with exercise training,
- Modification of medical treatment during the study,
- Unstable cardiac diseases,
- Participation in another pulmonary rehabilitation program over the past 12 months,
- Inadequate cooperation,
- Contraindications for the application of neuromuscular electrical stimulation (risk of embolism, neoplasm, infection in the region of application, pacemaker, sensory defect).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis
Pulmonary rehabilitation should be initiated and lifelong at the time of diagnosis for patients with IPF. However, the symptoms of the disease and its progression limit clinical options in terms of participation and sustainability in rehabilitation programs. For this purpose, patients with IPF need physiotherapy and rehabilitation options that will not increase the symptoms associated with exercise and contribute to the program in the long term. Neuromuscular electrical stimulation (NMES) is a rehabilitation option that can be applied to specific muscle groups without the ventilator and cardiac load especially in patients who can not actively exercise or have decreased muscle strength. In adult patients with an advanced disease characterized by reduced muscle strength, the use of NMES in addition to aerobic exercise programs is recommended as part of rehabilitation programs. In the literature, no studies investigating the efficacy of NMES have been found in individuals with IPF or interstitial lung disease. NMES application in addition to aerobic exercise seems to be a reasonable option when considering the symptoms of patients with IPF and the progression of the disease. The aim of this project is to investigate the efficacy of NMES in addition to aerobic exercise in IPF patients based on evidence by objective methods.
Read the detailed description
Idiopathic pulmonary fibrosis (IPF) is a progressive, fibrotic interstitial lung disease characterized by progressive dyspnoea, reduced exercise capacity, quality of life, and classified as a rare disease. With the increase in medical treatment options, the progression of the disease slows down. Increased time of survival has increased the need for pulmonary rehabilitation programs that have been shown to be effective in patients' exercise capacity, participation in daily living activities, and improvement in the quality of life. Patients with IPF have been shown to be able to improve dyspnoea, fatigue, exercise capacity, daily living activities and quality of life with home-based or supervised breathing, posture, strengthening and aerobic/endurance exercise programs.
Pulmonary rehabilitation should be initiated and lifelong at the time of diagnosis for patients with IPF. However, the symptoms of the disease and its progression limit clinical options in terms of participation and sustainability in rehabilitation programs. For this purpose, patients with IPF need physiotherapy and rehabilitation options that will not increase the symptoms associated with exercise and contribute to the program in the long term. Neuromuscular electrical stimulation (NMES) is a rehabilitation option that can be applied to specific muscle groups without the ventilator and cardiac load especially in patients who can not actively exercise or have decreased muscle strength. In adult patients with an advanced disease characterized by reduced muscle strength, the use of NMES in addition to aerobic exercise programs is recommended as part of rehabilitation programs. In the literature, no studies investigating the efficacy of NMES have been found in individuals with IPF or interstitial lung disease. NMES application in addition to aerobic exercise seems to be a reasonable option when considering the symptoms of patients with IPF and the progression of the disease. The aim of this project is to investigate the efficacy of NMES in addition to aerobic exercise in IPF patients based on evidence by objective methods.
- Being tested
- Aerobic exercise, Neuromuscular electrical stimulation
- Keywords
- pulmonary rehabilitation, neuromuscular electrical stimulation
- 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.
Aerobic exerciseOther
A 20-30 minutes low-medium intensity aerobic exercise training with cycling ergometer.
Neuromuscular electrical stimulationOther
Bilateral NMES application on Quadriceps femoris muscle will be applied as symmetrical biphasic square wave current with a wave frequency of 35-60 Hz, phase transition time of 8 seconds and active resting time of 15 seconds
| Study group | Role | What they receive |
|---|---|---|
| Sham group | Sham comparator | Following the assessments, sham group will participate in a 20-30 minute low-medium intensity aerobic exercise training with cycling ergometer. In Sham training group, NMES will be applied to the same region after aerobic exercise, current frequency is 5 Hz, current transit time is 300 μs, 10 seconds warning, 30 seconds electrical stimulation in 20 seconds rest period. The rehabilitation program will be administered two days a week for 8 weeks under the supervision of a physiotherapist. Receives: Other: Aerobic exercise |
| NMES group | Experimental | Following the assessments, both groups will participate in a 20-30 minute low-medium intensity aerobic exercise training with cycling ergometer.
After the aerobic exercise in NMES group, bilateral NMES application on Quadriceps femoris muscle will be applied as symmetrical biphasic square wave current with a wave frequency of 35-60 Hz, phase transition time of 8 seconds and active resting time of 15 seconds. Receives: Other: Aerobic exercise; Other: Neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of exercise capacity
Exercise capacity will be assessed with 6-minutes walk test. The six minutes walking distance will be recorded in "metres".
Measured: 2 months
Assessment of endurance capacity
Endurance capacity will be assessed with "Shuttle Endurance Walking test". The number of shuttles will be recorded and maximum VO2 will be calculated.
Measured: 2 months
Secondary outcomes (4)
Assessment of peripheral muscle strength
Peripheral muscle strength will be assessed with hand held dynamometer for quadriceps muscles.
Measured: 2 months
Assessment of fatigue
Fatigue will be assessed with Fatigue Severity Scale. The scale consists 9 questions. The minimum score is 0 and maximum score is 63. Higher scores indicate worse fatigue level.
Measured: 2 months
Assessment of activities of daily living
The activities of daily living will be assessed by "The London Chest Daily Activities of Daily Living Questionnaire. The scale has 4 subgroups; self-care (4 question), about home (six question), physical activity (2 question) and leisure time (3 question). The minimum score is 0 and maximum score is 75. Higher scores indicate worse conditions.
Measured: 2 months
Assessment of quality of life: "Saint George Quality of Life Survey
The quality of life will be assessed by "Saint George Quality of Life Survey". The scale consists 50 questions. The minimum score is 0 and the maksimum score is 100. Higher scores indicate poor quality of life.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start20 Mar 2019
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Model description
- Thirty IPF patients aged 40-80 years who are followed up at Istanbul University, Istanbul Medical Faculty Chest Disease Department will include in the study. Participants will be divided into two groups as the NMES group and the Sham Training Group, using a computer-assisted randomization table.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Istanbul University
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket Akıncı, Assist.Prof., Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890250
- Sponsor's protocol ID
- 2018/12-1
- Status last verified
- Jan 2024
- First submitted
- 13 Mar 2019
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holland AE, Wadell K, Spruit MA. How to adapt the pulmonary rehabilitation programme to patients with chronic respiratory disease other than COPD. Eur Respir Rev. 2013 Dec;22(130):577-86. doi: 10.1183/09059180.00005613.
PubMed 24293474Jones S, Man WD, Gao W, Higginson IJ, Wilcock A, Maddocks M. Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Cochrane Database Syst Rev. 2016 Oct 17;10(10):CD009419. doi: 10.1002/14651858.CD009419.pub3.
PubMed 27748503
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03890250
- Acronym / sponsor ID
- 2018/12-1
- Keywords
- pulmonary rehabilitation, neuromuscular electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Istanbul University
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 26 Mar 2019 (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.
Pulmonary rehabilitation should be initiated and lifelong at the time of diagnosis for patients with IPF. However, the symptoms of the disease and its progression limit clinical options in terms of participation and sustainability in rehabilitation programs. For this purpose, patients with IPF need physiotherapy and rehabilitation options that will not increase the symptoms associated with exercise and contribute to the program in the long term. Neuromuscular electrical stimulation (NMES) is a rehabilitation option that can be applied to specific muscle groups without the ventilator and cardiac load especially in patients who can not actively exercise or have decreased muscle strength. In adult patients with an advanced disease characterized by reduced muscle strength, the use of NMES in addition to aerobic exercise programs is recommended as part of rehabilitation programs. In the literature, no studies investigating the efficacy of NMES have been found in individuals with IPF or interstitial lung disease. NMES application in addition to aerobic exercise seems to be a reasonable option when considering the symptoms of patients with IPF and the progression of the disease. The aim of this project is to investigate the efficacy of NMES in addition to aerobic exercise in IPF patients based on evidence by objective methods.
Detailed description
Idiopathic pulmonary fibrosis (IPF) is a progressive, fibrotic interstitial lung disease characterized by progressive dyspnoea, reduced exercise capacity, quality of life, and classified as a rare disease. With the increase in medical treatment options, the progression of the disease slows down. Increased time of survival has increased the need for pulmonary rehabilitation programs that have been shown to be effective in patients' exercise capacity, participation in daily living activities, and improvement in the quality of life. Patients with IPF have been shown to be able to improve dyspnoea, fatigue, exercise capacity, daily living activities and quality of life with home-based or supervised breathing, posture, strengthening and aerobic/endurance exercise programs.
Pulmonary rehabilitation should be initiated and lifelong at the time of diagnosis for patients with IPF. However, the symptoms of the disease and its progression limit clinical options in terms of participation and sustainability in rehabilitation programs. For this purpose, patients with IPF need physiotherapy and rehabilitation options that will not increase the symptoms associated with exercise and contribute to the program in the long term. Neuromuscular electrical stimulation (NMES) is a rehabilitation option that can be applied to specific muscle groups without the ventilator and cardiac load especially in patients who can not actively exercise or have decreased muscle strength. In adult patients with an advanced disease characterized by reduced muscle strength, the use of NMES in addition to aerobic exercise programs is recommended as part of rehabilitation programs. In the literature, no studies investigating the efficacy of NMES have been found in individuals with IPF or interstitial lung disease. NMES application in addition to aerobic exercise seems to be a reasonable option when considering the symptoms of patients with IPF and the progression of the disease. The aim of this project is to investigate the efficacy of NMES in addition to aerobic exercise in IPF patients based on evidence by objective methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Thirty IPF patients aged 40-80 years who are followed up at Istanbul University, Istanbul Medical Faculty Chest Disease Department will include in the study. Participants will be divided into two groups as the NMES group and the Sham Training Group, using a computer-assisted randomization table.
| Arm | Type | Receives |
|---|---|---|
| Sham group | Sham comparator | Other: Aerobic exerciseFollowing the assessments, sham group will participate in a 20-30 minute low-medium intensity aerobic exercise training with cycling ergometer. In Sham training group, NMES will be applied to the same region after aerobic exercise, current frequency is 5 Hz, current transit time is 300 μs, 10 seconds warning, 30 seconds electrical stimulation in 20 seconds rest period. The rehabilitation program will be administered two days a week for 8 weeks under the supervision of a physiotherapist. |
| NMES group | Experimental | Other: Aerobic exercise, Other: Neuromuscular electrical stimulationFollowing the assessments, both groups will participate in a 20-30 minute low-medium intensity aerobic exercise training with cycling ergometer. After the aerobic exercise in NMES group, bilateral NMES application on Quadriceps femoris muscle will be applied as symmetrical biphasic square wave current with a wave frequency of 35-60 Hz, phase transition time of 8 seconds and active resting time of 15 seconds. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of IPF according to current ATS / ERS guidelines has been followed by a pulmonary specialist for at least 6 months
- Patients who are clinically stable, have no flare or infection.
Key exclusion criteria (6 listed)
- Orthopedic and neurological problems that may interfere with exercise training,
- Modification of medical treatment during the study,
- Unstable cardiac diseases,
- Participation in another pulmonary rehabilitation program over the past 12 months,
- Inadequate cooperation,
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 |
|---|---|---|
| Aerobic exerciseA 20-30 minutes low-medium intensity aerobic exercise training with cycling ergometer. | Other | NMES group, Sham group |
| Neuromuscular electrical stimulationBilateral NMES application on Quadriceps femoris muscle will be applied as symmetrical biphasic square wave current with a wave frequency of 35-60 Hz, phase transition time of 8 seconds and active resting time of 15 seconds | Other | NMES group |
Primary outcome
Assessment of exercise capacity
Time frame: 2 months
Exercise capacity will be assessed with 6-minutes walk test. The six minutes walking distance will be recorded in "metres".
Assessment of endurance capacity
Time frame: 2 months
Endurance capacity will be assessed with "Shuttle Endurance Walking test". The number of shuttles will be recorded and maximum VO2 will be calculated.
4 secondary outcomes
Assessment of peripheral muscle strength
Time frame: 2 months
Assessment of fatigue
Time frame: 2 months
Assessment of activities of daily living
Time frame: 2 months
Assessment of quality of life: "Saint George Quality of Life Survey
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Results publication: PubMed 24293474Holland AE, Wadell K, Spruit MA. How to adapt the pulmonary rehabilitation programme to patients with chronic respiratory disease other than COPD. Eur Respir Rev. 2013 Dec;22(130):577-86. doi: 10.1183/09059180.00005613.
- Results publication: PubMed 27748503Jones S, Man WD, Gao W, Higginson IJ, Wilcock A, Maddocks M. Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Cochrane Database Syst Rev. 2016 Oct 17;10(10):CD009419. doi: 10.1002/14651858.CD009419.pub3.
- 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. This study is not recruiting at the moment.
Buket Akıncı, Assist.Prof. principal investigator
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Neuromuscular electrical stimulation in people with Idiopathic Pulmonary Fibrosis and Neuromuscular Electrical Stimulation, run by Biruni University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of exercise capacity (time frame: 2 months). 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?
On the ClinicalTrials.gov record for NCT03890250, which also lists 2 linked publications.
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 29 Jan 2024.