Heart DiseasesNCT04973865
Cross Cultural Adaptation of International Physical Activity Questionaire Short Form in Urdu Version
An observational study of Heart Diseases, run by Riphah International University at 1 site in Pakistan.
Trial summary
The IPAQ-SF scale is widely used in our clinical settings. The translated version of IPAQ-SF scale in Urdu will help the clinician in collecting data thus, easy to understand for the patient and making it more desirable in our region. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Validation & reliability
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Aug 2020to 30 Apr 2021
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diseased and Healthy individual group to evaluate the Physical Activity and do validation of IPAQ Short form Urdu Version. Test retest reliability in both group for IPQ short form urdu version.
Who may be able to join
- Patients who have chronic diseases, such as cardiovascular, pulmonary and metabolic disease will consider as high risk, those who have more than two number of CAD risk factor will categorize as mild and patients have less than two risk factor of CAD will consider as low risk factor.(ACSM risk stratification guide lines)
- Those who can read and understand English and Urdu as well.
Who cannot join
- Those with known Parkinson's disease, cerebrovascular disease or dementia.
- Individuals have difficulty with reading because of low educational level
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Railway General Hospital
Rawalpindi, Punjab Province, 43600
About this study
The IPAQ-SF scale is widely used in our clinical settings. The translated version of IPAQ-SF scale in Urdu will help the clinician in collecting data thus, easy to understand for the patient and making it more desirable in our region.
Read the detailed description
The purpose of study is to translate IPAQ-SF (International Physical Activity Questionnaire- short form) scale in Urdu and to determine the validity \& reliability of IPAQ-SF in Urdu version. Patients who are at high risk of chronic diseases such as cardiovascular disease, diabetes, and hypertension age between 30 to 65 years and can understand Urdu and English language are included in my study. 6mint walk test performed to assess aerobic capacity and endurance and physical activity over the last seven days is recorded on the translated version of IPAQ-SF in Urdu and then back of Urdu into English.
- Conditions
- Heart Diseases
- Being tested
- Validation & reliability
- Keywords
- IPAQ-SF, 6MWT, Rate pressure product
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation & reliabilityOther
Also called Translated Tool
Translated version of IPAQ(SF) validation \& Reliability
| Study group | Role | What they receive |
|---|---|---|
| Disease Population | 50 Patients who have chronic diseases, such as cardiovascular, will consider as high risk, those who have more than two number of CAD risk factor will categorize as mild and patients have less than two risk factor of CAD will consider as low risk factor. (ACSM risk stratification guide lines) Receives: Other: Validation & reliability | |
| Healthy | 30 Healthy individual with no cardiac diseased. Receives: Other: Validation & reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate Pressure Product
Rate pressure product is amount of stress on cardiac muscle during each beat and amount of blood pressure exert against arterial circulation (SBP).
Measured: One day
6 minute Walk Test
Area that is covered during six minutes shows the result with whom functional capability is compared. Walkway with no obstruction and an area of thirty meter is used and patient is told to keep walking for the duration of six minutes.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start21 Aug 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumaiyah Obaid, MS, Principal investigator, Riphah International UniversityIqbal Tariq, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973865
- Sponsor's protocol ID
- REC00758 Syeda Sumaira
- Status last verified
- Jul 2021
- First submitted
- 17 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hervas G, Ruiz-Litago F, Irazusta J, Fernandez-Atutxa A, Fraile-Bermudez AB, Zarrazquin I. Physical Activity, Physical Fitness, Body Composition, and Nutrition Are Associated with Bone Status in University Students. Nutrients. 2018 Jan 10;10(1):61. doi: 10.3390/nu10010061.
PubMed 29320446Helou K, El Helou N, Mahfouz M, Mahfouz Y, Salameh P, Harmouche-Karaki M. Validity and reliability of an adapted arabic version of the long international physical activity questionnaire. BMC Public Health. 2017 Jul 24;18(1):49. doi: 10.1186/s12889-017-4599-7.
PubMed 28738790Macfarlane DJ, Lee CC, Ho EY, Chan KL, Chan DT. Reliability and validity of the Chinese version of IPAQ (short, last 7 days). J Sci Med Sport. 2007 Feb;10(1):45-51. doi: 10.1016/j.jsams.2006.05.003. Epub 2006 Jun 30.
PubMed 16807105
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Cultural Adaptation of International Physical Activity Questionaire Short Form in Urdu Version
- ClinicalTrials.gov ID
- NCT04973865
- Acronym / sponsor ID
- REC00758 Syeda Sumaira
- Conditions
- Heart Diseases
- Keywords
- IPAQ-SF, 6MWT, Rate pressure product
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 22 Jul 2021 (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.
The IPAQ-SF scale is widely used in our clinical settings. The translated version of IPAQ-SF scale in Urdu will help the clinician in collecting data thus, easy to understand for the patient and making it more desirable in our region.
Detailed description
The purpose of study is to translate IPAQ-SF (International Physical Activity Questionnaire- short form) scale in Urdu and to determine the validity \& reliability of IPAQ-SF in Urdu version. Patients who are at high risk of chronic diseases such as cardiovascular disease, diabetes, and hypertension age between 30 to 65 years and can understand Urdu and English language are included in my study. 6mint walk test performed to assess aerobic capacity and endurance and physical activity over the last seven days is recorded on the translated version of IPAQ-SF in Urdu and then back of Urdu into English.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease Population | – | Other: Validation & reliability50 Patients who have chronic diseases, such as cardiovascular, will consider as high risk, those who have more than two number of CAD risk factor will categorize as mild and patients have less than two risk factor of CAD will consider as low risk factor. (ACSM risk stratification guide lines) |
| Healthy | – | Other: Validation & reliability30 Healthy individual with no cardiac diseased. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diseased and Healthy individual group to evaluate the Physical Activity and do validation of IPAQ Short form Urdu Version. Test retest reliability in both group for IPQ short form urdu version.
Key inclusion criteria (2 listed)
- Patients who have chronic diseases, such as cardiovascular, pulmonary and metabolic disease will consider as high risk, those who have more than two number of CAD risk factor will categorize as mild and patients have less than two risk factor of CAD will consider as low risk factor.(ACSM risk stratification guide lines)
- Those who can read and understand English and Urdu as well.
Key exclusion criteria (2 listed)
- Those with known Parkinson's disease, cerebrovascular disease or dementia.
- Individuals have difficulty with reading because of low educational level
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 |
|---|---|---|
| Validation & reliabilityAlso: Translated ToolTranslated version of IPAQ(SF) validation \& Reliability | Other | Disease Population, Healthy |
Primary outcome
Rate Pressure Product
Time frame: One day
Rate pressure product is amount of stress on cardiac muscle during each beat and amount of blood pressure exert against arterial circulation (SBP).
6 minute Walk Test
Time frame: One day
Area that is covered during six minutes shows the result with whom functional capability is compared. Walkway with no obstruction and an area of thirty meter is used and patient is told to keep walking for the duration of six minutes.
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 22 Jul 2021.
- Background: PubMed 29320446Hervas G, Ruiz-Litago F, Irazusta J, Fernandez-Atutxa A, Fraile-Bermudez AB, Zarrazquin I. Physical Activity, Physical Fitness, Body Composition, and Nutrition Are Associated with Bone Status in University Students. Nutrients. 2018 Jan 10;10(1):61. doi: 10.3390/nu10010061.
- Background: PubMed 28738790Helou K, El Helou N, Mahfouz M, Mahfouz Y, Salameh P, Harmouche-Karaki M. Validity and reliability of an adapted arabic version of the long international physical activity questionnaire. BMC Public Health. 2017 Jul 24;18(1):49. doi: 10.1186/s12889-017-4599-7.
- Background: PubMed 16807105Macfarlane DJ, Lee CC, Ho EY, Chan KL, Chan DT. Reliability and validity of the Chinese version of IPAQ (short, last 7 days). J Sci Med Sport. 2007 Feb;10(1):45-51. doi: 10.1016/j.jsams.2006.05.003. Epub 2006 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.
Sumaiyah Obaid, MS principal investigator
Riphah International University
Iqbal Tariq, MS 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?
An observational study of Heart Diseases, 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 2 inclusion and 2 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 22 Jul 2021. 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?
Rate Pressure Product (time frame: One day). 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 NCT04973865, which also lists 3 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 22 Jul 2021.