RehabilitationNCT06677047
Rehabilitation in Patients With Pulmonary Fibrosis
An observational study of Rehabilitation, run by Assiut University.
Trial summary
This study aims to explore the effects of exercise rehabilitation on the functional status of patients with pulmonary fibrosis, assessing both physical and psychological dimensions of health. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rehabilitation
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 20 Aug 2025
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Demographic Data Collection: * Age, sex, duration of pulmonary fibrosis, and medical history. 2. Pulmonary Function Testing: * Spirometry will be conducted to assess Forced Vital Capacity (FVC) and Forced Expiratory Volume in one second (FEV1). 3. Functional Capacity Assessment: * The Six-Minute Walk Test (6MWT) will be performed to evaluate baseline exercise tolerance. 4. Quality of Life Evaluation: * Health-related quality of life will be assessed using the St. George's Respiratory Questionnaire (SGRQ) or Chronic Respiratory Disease Questionnaire (CRQ). 5. Dyspnea Assessment: * Dyspnea levels will be measured using the Modified Medical Research Council (mMRC) dyspnea scale. * Exercise Rehabilitation Program Participants will engage in a structured 8-week exercise rehabilitation program, which includes: * Supervised Exercise Sessions: * Participants will attend twice-weekly sessions led by trained physiotherapists, focusing on aerobic
Who may be able to join
- 1. Diagnosis of Pulmonary Fibrosis:
- Patients must have a confirmed diagnosis of pulmonary fibrosis, as determined by clinical evaluation and imaging studies (e.g., high-resolution computed tomography).
- 2. Age Range:
- Participants should be adults aged 18 years and older to capture the adult population affected by the disease.
- 3. Stable Clinical Condition:
- Patients must be in a stable clinical condition, defined as no exacerbations or significant changes in treatment for at least four weeks prior to enrollmen
Who cannot join
- 1. Other Significant Lung Diseases:
- Patients with concurrent respiratory conditions (e.g., chronic obstructive pulmonary disease, asthma, or lung cancer) that could confound the results.
- 2. Acute Exacerbations:
- Individuals experiencing an acute exacerbation of pulmonary fibrosis or any significant respiratory illness within four weeks prior to enrollment.
- 3. Severe Comorbidities:
- Patients with severe cardiovascular disease, uncontrolled hypertension, major neurological disorders, or musculoskeletal problems that would impede participation in exercise.
- 4. Cognitive Impairment:
- Individuals with cognitive impairments that prevent them from understanding the study procedures or following the rehabilitation program.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Improvement in Functional Status of Patients With Pulmonary Fibrosis After Exercise Rehabilitation Program
This study aims to explore the effects of exercise rehabilitation on the functional status of patients with pulmonary fibrosis, assessing both physical and psychological dimensions of health. By identifying significant improvements, we can contribute to the development of comprehensive rehabilitation strategies that enhance patient outcomes and foster a better quality of life for those affected by this challenging condition
Read the detailed description
program is essential for understanding its efficacy. Functional status refers to an individual's ability to perform daily activities and maintain independence, which is particularly important for patients with chronic illnesses like PF. Evaluating changes in functional status not only helps in determining the success of rehabilitation efforts but also provides insights into the overall impact of exercise on patients' quality of life.
- Conditions
- Rehabilitation
What is being measured
The primary outcome is the main question the study is designed to answer.
**Asses Health-Related Quality of Life:**
Assessed through validated questionnaires such as the St. George's Respiratory Questionnaire (SGRQ)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start20 Jan 2025 (estimated)
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mohamed Sayed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677047
- Sponsor's protocol ID
- ILD& Rehabilitation
- Status last verified
- Oct 2024
- First submitted
- 5 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Troosters T, Janssens W, Demeyer H, Rabinovich RA. Pulmonary rehabilitation and physical interventions. Eur Respir Rev. 2023 Jun 7;32(168):220222. doi: 10.1183/16000617.0222-2022. Print 2023 Jun 30.
PubMed 37286219
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Improvement in Functional Status of Patients With Pulmonary Fibrosis After Exercise Rehabilitation Program
- ClinicalTrials.gov ID
- NCT06677047
- Acronym / sponsor ID
- ILD& Rehabilitation
- Conditions
- Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Aug 2025 (estimated)
- First posted
- 6 Nov 2024 (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.
This study aims to explore the effects of exercise rehabilitation on the functional status of patients with pulmonary fibrosis, assessing both physical and psychological dimensions of health. By identifying significant improvements, we can contribute to the development of comprehensive rehabilitation strategies that enhance patient outcomes and foster a better quality of life for those affected by this challenging condition
Detailed description
program is essential for understanding its efficacy. Functional status refers to an individual's ability to perform daily activities and maintain independence, which is particularly important for patients with chronic illnesses like PF. Evaluating changes in functional status not only helps in determining the success of rehabilitation efforts but also provides insights into the overall impact of exercise on patients' quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Demographic Data Collection: * Age, sex, duration of pulmonary fibrosis, and medical history. 2. Pulmonary Function Testing: * Spirometry will be conducted to assess Forced Vital Capacity (FVC) and Forced Expiratory Volume in one second (FEV1). 3. Functional Capacity Assessment: * The Six-Minute Walk Test (6MWT) will be performed to evaluate baseline exercise tolerance. 4. Quality of Life Evaluation: * Health-related quality of life will be assessed using the St. George's Respiratory Questionnaire (SGRQ) or Chronic Respiratory Disease Questionnaire (CRQ). 5. Dyspnea Assessment: * Dyspnea levels will be measured using the Modified Medical Research Council (mMRC) dyspnea scale. * Exercise Rehabilitation Program Participants will engage in a structured 8-week exercise rehabilitation program, which includes: * Supervised Exercise Sessions: * Participants will attend twice-weekly sessions led by trained physiotherapists, focusing on aerobic
Key inclusion criteria (6 listed)
- 1. Diagnosis of Pulmonary Fibrosis:
- Patients must have a confirmed diagnosis of pulmonary fibrosis, as determined by clinical evaluation and imaging studies (e.g., high-resolution computed tomography).
- 2. Age Range:
- Participants should be adults aged 18 years and older to capture the adult population affected by the disease.
- 3. Stable Clinical Condition:
Key exclusion criteria (8 listed)
- 1. Other Significant Lung Diseases:
- Patients with concurrent respiratory conditions (e.g., chronic obstructive pulmonary disease, asthma, or lung cancer) that could confound the results.
- 2. Acute Exacerbations:
- Individuals experiencing an acute exacerbation of pulmonary fibrosis or any significant respiratory illness within four weeks prior to enrollment.
- 3. Severe Comorbidities:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asses Health-Related Quality of Life:
Time frame: Baseline
Assessed through validated questionnaires such as the St. George's Respiratory Questionnaire (SGRQ)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Results publication: PubMed 37286219Troosters T, Janssens W, Demeyer H, Rabinovich RA. Pulmonary rehabilitation and physical interventions. Eur Respir Rev. 2023 Jun 7;32(168):220222. doi: 10.1183/16000617.0222-2022. Print 2023 Jun 30.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Rehabilitation, run by Assiut University.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hend Mohamed Sayed, Doctor (01098988712, hend.m.saleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asses Health-Related Quality of Life: (time frame: Baseline). 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 NCT06677047, which also lists 1 linked publication.
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 6 Nov 2024.