PneumoniaNCT05174741
Pulmonary Rehabilitation in Non-chronic Obstructive Pulmonary Disease Patients.
A study testing Conventional Chest Physiotherapy and Aerobic training Group in people with Pneumonia and Pulmonary Fibrosis, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effect of pulmonary rehabilitation on pulmonary function in non-chronic obstructive pulmonary disease patients.To determine the effect of pulmonary rehabilitation on health related quality of life in non-chronic obstructive pulmonary disease patients.Limited researches are available in non chronic… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Pneumonia, Pulmonary Fibrosis, Tuberculosis
- What is being tested?
- Conventional Chest Physiotherapy and Aerobic training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- Apr 2023to Feb 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed cases of non-COPD disease interstitial lung disease (pulmonary fibrosis), restrictive lung disease (TB, pneumonia), Bronchiectasis, and Asthma with FEV1 below 50%, FVC<80%, and FEV1/FVC>70%
Who cannot join
- Clinically/vitally unstable or having Uncontrolled DM/HTN, Current smokers or ex-smokers of less than 1 year.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan railway hospital
Rawalpindi, Punjab Province, 43600
Mehwish Waseem, MSPT(CPPT), 03315309015, mehwish.waseem@riphah.edu.pk
Aleena Ashraf, MSPT(CPPT)*
About this study
Official title: Effects of Pulmonary Rehabilitation Therapy on Pulmonary Function and Health Related Quality of Life in Non-chronic Obstructive Pulmonary Disease Patients
To determine the effect of pulmonary rehabilitation on pulmonary function in non-chronic obstructive pulmonary disease patients.To determine the effect of pulmonary rehabilitation on health related quality of life in non-chronic obstructive pulmonary disease patients.Limited researches are available in non chronic obstructive pulmonary disease patients.
Read the detailed description
A review state that "Interstitial lung disease presents clinical features of exertional desaturation and a nonproductive cough. Patients with ILD have significantly reduced exercise capacity as manifested by a reduced maximum work load achieved during exercise, as well as a reduced maximal oxygen uptake VO2max." in previous studies Pulmonary rehabilitation is the use of exercise, education and behavioral interventions for diseases such as non-ILD restrictive lung disease, asthma, lung cancer, bronchiectasis , and pulmonary hypertension, pre and post op thoracic surgery patients.
Quality of life (QOL) as an individual's perception of contentment or satisfaction with life in areas he or she considers important, and we define health-related quality of life (HRQL) as an individual's perception of the impact of health (in all its many facets) on his or her quality of life. a study on pulmonary rehabilitation outcomes between individuals with chronic obstructive lung disease (COPD) and non-COPD disease and its impact on gender.
- Conditions
- Pneumonia, Pulmonary Fibrosis, Tuberculosis, Bronchiectasis, Asthma
- Being tested
- Conventional Chest Physiotherapy, Aerobic training Group
- Keywords
- non-COPD, quality of life, pulmonary function
- Medical subject headings
- Pneumonia, Pulmonary Fibrosis, Tuberculosis, Bronchiectasis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Chest PhysiotherapyOther
Diaphragmatic Breathing exercise 15 repetition ACBT *3 sets/session*TD Walk (10-15 minutes) * BD
Aerobic training GroupOther
Supervised Conventional Chest Physiotherapy + Aerobic training
Aerobic training on cycle ergometer:
between 50% and 70% Vo2max, perceived exertion up to 11 on Borg scale 20-30 min/session/day
| Study group | Role | What they receive |
|---|---|---|
| Conventional Chest Physiotherapy | Active comparator | Diaphragmatic Breathing exercise 15 repetition ACBT *3 sets/session*TD Walk (10-15 minutes) * BD Receives: Other: Conventional Chest Physiotherapy |
| Aerobic Training group | Experimental | Supervised Conventional chest physiotherapy+ Aerobic training Conventional chest physiotherapy supervised (1st week) Then non supervised for 2nd to 6th week Warm-up (5 minutes) Breathing exercise and stepping Diaphragmatic Breathing exercise *15 Reps* TD
Aerobic training on cycle ergometer:
between 50% and 70% Vo2max, perceived exertion up to 11 on Borg scale 20-30 min/session/day Cool down (5 minutes) AROM +Body stretch Receives: Other: Aerobic training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 second (FEV1)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Measured: 3 weeks, 6 weeks
Forced vital Capacity (FVC)
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Measured: 3 weeks,6 weeks
Peak Expiratory Flow (PEF)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Measured: 3 weeks,6 weeks
Secondary outcomes (1)
Health related Quality of life
Measured through St. George's Respiratory Questionnaire in its COPD-specific version (SGRQ-C). The SGRQ-C with 40 items provides three component scores for symptoms, activity and impact, and a total score. Each score ranges from 0 (no impairment) to 100 (worst possible). A difference of 4 unit points is considered the minimum clinically important difference (MCID).
Measured: 3 weeks,6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study startApr 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Waseem, MSPT(CPPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174741
- Sponsor's protocol ID
- Rec/00882 Aleena Ashraf
- Status last verified
- Feb 2023
- First submitted
- 21 Jun 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulmonary Rehabilitation Therapy on Pulmonary Function and Health Related Quality of Life in Non-chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT05174741
- Acronym / sponsor ID
- Rec/00882 Aleena Ashraf
- Conditions
- Pneumonia, Pulmonary Fibrosis, Tuberculosis, Bronchiectasis, Asthma
- Keywords
- non-COPD, quality of life, pulmonary function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 3 Jan 2022 (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.
To determine the effect of pulmonary rehabilitation on pulmonary function in non-chronic obstructive pulmonary disease patients.To determine the effect of pulmonary rehabilitation on health related quality of life in non-chronic obstructive pulmonary disease patients.Limited researches are available in non chronic obstructive pulmonary disease patients.
Detailed description
A review state that "Interstitial lung disease presents clinical features of exertional desaturation and a nonproductive cough. Patients with ILD have significantly reduced exercise capacity as manifested by a reduced maximum work load achieved during exercise, as well as a reduced maximal oxygen uptake VO2max." in previous studies Pulmonary rehabilitation is the use of exercise, education and behavioral interventions for diseases such as non-ILD restrictive lung disease, asthma, lung cancer, bronchiectasis , and pulmonary hypertension, pre and post op thoracic surgery patients.
Quality of life (QOL) as an individual's perception of contentment or satisfaction with life in areas he or she considers important, and we define health-related quality of life (HRQL) as an individual's perception of the impact of health (in all its many facets) on his or her quality of life. a study on pulmonary rehabilitation outcomes between individuals with chronic obstructive lung disease (COPD) and non-COPD disease and its impact on gender.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Chest Physiotherapy | Active comparator | Other: Conventional Chest PhysiotherapyDiaphragmatic Breathing exercise 15 repetition ACBT *3 sets/session*TD Walk (10-15 minutes) * BD |
| Aerobic Training group | Experimental | Other: Aerobic training GroupSupervised Conventional chest physiotherapy+ Aerobic training Conventional chest physiotherapy supervised (1st week) Then non supervised for 2nd to 6th week Warm-up (5 minutes) Breathing exercise and stepping Diaphragmatic Breathing exercise *15 Reps* TD Aerobic training on cycle ergometer: between 50% and 70% Vo2max, perceived exertion up to 11 on Borg scale 20-30 min/session/day Cool down (5 minutes) AROM +Body stretch |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosed cases of non-COPD disease interstitial lung disease (pulmonary fibrosis), restrictive lung disease (TB, pneumonia), Bronchiectasis, and Asthma with FEV1 below 50%, FVC<80%, and FEV1/FVC>70%
Key exclusion criteria (1 listed)
- Clinically/vitally unstable or having Uncontrolled DM/HTN, Current smokers or ex-smokers of less than 1 year.
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 |
|---|---|---|
| Conventional Chest PhysiotherapyDiaphragmatic Breathing exercise 15 repetition ACBT *3 sets/session*TD Walk (10-15 minutes) * BD | Other | Conventional Chest Physiotherapy |
| Aerobic training GroupSupervised Conventional Chest Physiotherapy + Aerobic training Aerobic training on cycle ergometer: between 50% and 70% Vo2max, perceived exertion up to 11 on Borg scale 20-30 min/session/day | Other | Aerobic Training group |
Primary outcome
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 3 weeks, 6 weeks
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Forced vital Capacity (FVC)
Time frame: 3 weeks,6 weeks
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Peak Expiratory Flow (PEF)
Time frame: 3 weeks,6 weeks
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
1 secondary outcome
Health related Quality of life
Time frame: 3 weeks,6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- 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.
Mehwish Waseem, MSPT(CPPT) principal investigator
Riphah International 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 Conventional Chest Physiotherapy and Aerobic training Group in people with Pneumonia and Pulmonary Fibrosis, run by Riphah International University at 1 site in Pakistan.
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 1 inclusion and 1 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 21 Feb 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Expiratory Volume in 1 second (FEV1) (time frame: 3 weeks, 6 weeks). The study lists 3 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 21 Feb 2023.