COPDNCT05828602
Pulmonary Rehabilitation Through Tele Rehabilitation for COPD in Pakistan
A study testing Conventional treatment and TeleRehabilitation in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the feasibility of Tele-rehabilitation vs traditional center-based pulmonary rehabilitation for people with chronic obstructive pulmonary disease Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Conventional treatment and TeleRehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Apr 2023to 1 Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a primary diagnosis of a chronic obstructive pulmonary disease
- aged ≥40 years
- be able to read and speak Urdu
- Vitally stable
- both gender
Who cannot join
- Inability to use technology, inadequate home setting, and patient's refusal.
- pulmonary hypertension or lung cancer attended pulmonary rehabilitation within the previous 18 months and had no hospitalizations for a respiratory cause since rehabilitation completion
- oxygen desaturation resulting in cessation of cardiopulmonary exercise testing (e.g. SpO2 \< 80% during exercise on cycle ergometer)
- to ensure safety of unsupervised training
- unstable or brittle asthma with a hospital admission or emergency department presentation within the preceding 3 months, to ensure safety of unsupervised training
- co-morbidities which preclude exercise training, such as neurological or musculoskeletal impairment
- unable to follow verbal instructions, suffer from cognitive impairment, or have language difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Pulmonary Rehabilitation Through Tele Rehabilitation Versus Traditional Center Based Pulmonary Rehabilitation for COPD in Pakistan
To determine the feasibility of Tele-rehabilitation vs traditional center-based pulmonary rehabilitation for people with chronic obstructive pulmonary disease
- Conditions
- COPD
- Being tested
- Conventional treatment, TeleRehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatmentOther
Conventional treatment
TeleRehabilitationOther
TeleRehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Active comparator | Not described Receives: Other: Conventional treatment |
| TeleRehabilitation | Experimental | Not described Receives: Other: TeleRehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic respiratory questionnaire
The chronic respiratory questionnaire has 20 items spread over four domains:
dyspnea (5 items), tiredness (4 items), emotional function (7 items), and mastery. It can be administered by an interviewer or self-administered (4 items). Patients complete a 7-point rating scale on this form, with 1 being the worst possible experience and 7 being the best possible one (no impairment)
Measured: 40 Days
Physical activity via IPAQ
Any voluntary skeletal muscle-driven movement that involves an energy cost is referred to as physical activity. All activities, regardless of intensity or time of day or night, can be considered physical activity. Both physical activity and unplanned activities incorporated into everyday routines are included . International Physical Activity Questionnaire short from will be utilized to measure level of physical activity. It consists of 7 items which ask about the activity of the last 7 days
Measured: 40 Days
Quality of life - Sf 12
The World Health Organization defines quality of life as \"a person\'s view of their place in life in relation to their objectives, aspirations, standards, and concerns in the context of the culture and value systems in which they live.\" (20) . QOL will be assess via SF-12 Questionnaire. The SF-12 is a self-reported outcome measure that evaluates how one\'s health affects their day-to-day activities
Measured: 40 Days
Body mass index
The body mass index (BMI) is a measurement that is based on a person\'s height and weight. The BMI is calculated by dividing the body weight by the square of the height, and it is expressed in kilograms per square meter (kg/m2) since weight is measured in kilograms and height is measured in meters
Measured: 40 Days
Borg Scale
It is generally recognised that the Borg rating of perceived exertion scale is a reliable tool for determining perceived effort for a range of exercise modalities. The Borg scale (6-20) is intended to provide you with an approximation of your degree of effort based on your real heart rate when exercising. To determine your predicted heart rate, multiply your RPE by 10
Measured: 40 Days
Level of satisfaction scale
It is a question that ranges from one extreme attitude to another using a 5 or 7- point scale that is sometimes referred to as a satisfaction scale. Very satisfied, Satisfied, Neither satisfied nor unsatisfied, Dissatisfied, and Very dissatisfied are examples of common responses on a 5-point Likert scale used to gauge satisfaction
Measured: 40 Days
Self-Structure open ended Questions
Self-structured questionnaire was designed after reviewing the literature and with the help of experts in the field. it includes open ended questions, These questions will be asked in interview form from both the groups i.e Traditional Center Based Pulmonary Rehabilitation group and Tele Rehabilitation group, in which views on exercise, disease education, social contact, activity, accessibility, and support for participation will be assessed. This self-structured questionnaire will be a type of cognitive interview from both the groups.
Measured: 40 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start20 Apr 2023
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828602
- Sponsor's protocol ID
- Rec/01373 Mehwish Haider
- Status last verified
- Jul 2023
- First submitted
- 12 Apr 2023
- Last updated
- 10 Jul 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 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Pulmonary Rehabilitation Through Tele Rehabilitation Versus Traditional Center Based Pulmonary Rehabilitation for COPD in Pakistan
- ClinicalTrials.gov ID
- NCT05828602
- Acronym / sponsor ID
- Rec/01373 Mehwish Haider
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 25 Apr 2023 (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 feasibility of Tele-rehabilitation vs traditional center-based pulmonary rehabilitation for people with chronic obstructive pulmonary disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Active comparator | Other: Conventional treatment |
| TeleRehabilitation | Experimental | Other: TeleRehabilitation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have a primary diagnosis of a chronic obstructive pulmonary disease
- aged ≥40 years
- be able to read and speak Urdu
- Vitally stable
- both gender
Key exclusion criteria (7 listed)
- Inability to use technology, inadequate home setting, and patient's refusal.
- pulmonary hypertension or lung cancer attended pulmonary rehabilitation within the previous 18 months and had no hospitalizations for a respiratory cause since rehabilitation completion
- oxygen desaturation resulting in cessation of cardiopulmonary exercise testing (e.g. SpO2 \< 80% during exercise on cycle ergometer)
- to ensure safety of unsupervised training
- unstable or brittle asthma with a hospital admission or emergency department presentation within the preceding 3 months, to ensure safety of unsupervised training
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 treatmentConventional treatment | Other | Conventional treatment |
| TeleRehabilitationTeleRehabilitation | Other | TeleRehabilitation |
Primary outcome
Chronic respiratory questionnaire
Time frame: 40 Days
The chronic respiratory questionnaire has 20 items spread over four domains: dyspnea (5 items), tiredness (4 items), emotional function (7 items), and mastery. It can be administered by an interviewer or self-administered (4 items). Patients complete a 7-point rating scale on this form, with 1 being the worst possible experience and 7 being the best possible one (no impairment)
Physical activity via IPAQ
Time frame: 40 Days
Any voluntary skeletal muscle-driven movement that involves an energy cost is referred to as physical activity. All activities, regardless of intensity or time of day or night, can be considered physical activity. Both physical activity and unplanned activities incorporated into everyday routines are included . International Physical Activity Questionnaire short from will be utilized to measure level of physical activity. It consists of 7 items which ask about the activity of the last 7 days
Quality of life - Sf 12
Time frame: 40 Days
The World Health Organization defines quality of life as \"a person\'s view of their place in life in relation to their objectives, aspirations, standards, and concerns in the context of the culture and value systems in which they live.\" (20) . QOL will be assess via SF-12 Questionnaire. The SF-12 is a self-reported outcome measure that evaluates how one\'s health affects their day-to-day activities
Body mass index
Time frame: 40 Days
The body mass index (BMI) is a measurement that is based on a person\'s height and weight. The BMI is calculated by dividing the body weight by the square of the height, and it is expressed in kilograms per square meter (kg/m2) since weight is measured in kilograms and height is measured in meters
Borg Scale
Time frame: 40 Days
It is generally recognised that the Borg rating of perceived exertion scale is a reliable tool for determining perceived effort for a range of exercise modalities. The Borg scale (6-20) is intended to provide you with an approximation of your degree of effort based on your real heart rate when exercising. To determine your predicted heart rate, multiply your RPE by 10
Level of satisfaction scale
Time frame: 40 Days
It is a question that ranges from one extreme attitude to another using a 5 or 7- point scale that is sometimes referred to as a satisfaction scale. Very satisfied, Satisfied, Neither satisfied nor unsatisfied, Dissatisfied, and Very dissatisfied are examples of common responses on a 5-point Likert scale used to gauge satisfaction
Self-Structure open ended Questions
Time frame: 40 Days
Self-structured questionnaire was designed after reviewing the literature and with the help of experts in the field. it includes open ended questions, These questions will be asked in interview form from both the groups i.e Traditional Center Based Pulmonary Rehabilitation group and Tele Rehabilitation group, in which views on exercise, disease education, social contact, activity, accessibility, and support for participation will be assessed. This self-structured questionnaire will be a type of cognitive interview from both the groups.
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 10 Jul 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.
Muhammad Iqbal Tariq, PhD* 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 treatment and TeleRehabilitation in people with COPD, 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 5 inclusion and 7 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 10 Jul 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?
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?
Chronic respiratory questionnaire (time frame: 40 Days). The study lists 7 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 10 Jul 2023.