Osteoporosis, PostmenopausalNCT03125590
Validation, Reliability and Pilot Test of the Personalized Exercise Questionnaire (PEQ)
An observational study of Osteoporosis, Postmenopausal and Osteopenia, run by McMaster University at 1 site in Canada.
Trial summary
The PEQ is the first tool to measure facilitators, barriers, and preferences to exercise in people with osteoporosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal, Osteopenia
- What is being tested?
- Testing the PEQ (Personalized Exercise Questionnaire)
- How many people
- 114 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2017to 11 Aug 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Peoples with a diagnosis of primary osteoporosis or osteopenia.
Who may be able to join
- The participant is able and willing to provide informed consent
- The participant is male or female, 18+
- The participant has received a diagnosis, from a physician, of primary osteopenia or osteoporosis (T < - 1.0)
- The participant can read and write English
Who cannot join
- The participant has been diagnosed with secondary osteopenia or osteoporosis
- The participant has a history of smoking, alcoholism, gastrointestinal disease, hypercalciuria and/or steroid use.
- The participant is diagnosed with a reading disability or dyslexia
- The participant has a cognitive impairment of some severity as to adversely affect the validity of the data
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Health Care Centre; Charlton Site
Hamitlon, Ontario, L8N1Y2
About this study
Official title: Reliability and Validity Study of the Facilitators and Barriers Exercise Questionnaire
The PEQ is the first tool to measure facilitators, barriers, and preferences to exercise in people with osteoporosis.
Read the detailed description
Osteoporosis is a disease of the bones characterized by low bone mass and microarchitectural deterioration of bone tissue. This disease can increase the risk of bone fragility fractures and is indirectly associated with premature death. These fractures are more common than cancer or heart disease in North American women 50 years or older, with an osteoporotic fracture occurring every 3 seconds worldwide, and are a major issue to patients and the healthcare system. Increased fracture rates, particularly in the hip and spine, may lead to hospitalization and subsequent immobility.
Some studies have shown fitness to be a better predictor of bone mineral density than age, yet adherence to exercise is poor. Studies suggest that 50% of those registered in an exercise program drop out within the first 6 months, lack of time being the number one barrier in many populations. To increase adherence to an exercise program, a systematic review has identified a number of facilitators and barriers to exercise in adults with osteoporosis and osteopenia.
Hitherto, no measurement tool has been created to measure these facilitators and barriers in people with osteoporosis. The investigators have developed and validated the PEQ (Personalized Exercise Questionnaire), a new tool that can measure the facilitators, barriers, and preferences to exercise. The next steps are to test the reliability, known-group validity, and pilot test this tool in the osteoporosis population.
Future physical activity or exercise interventions could benefit from using this tool to leveraging the facilitators and limiting the barriers to exercise to increase adherence to an exercise program.
- Conditions
- Osteoporosis, Postmenopausal, Osteopenia
- Being tested
- Testing the PEQ (Personalized Exercise Questionnaire)
- Keywords
- Osteoporosis, osteopenia, test-retest, validity, PEQ, questionnaire, facilitators, barriers, exercise, physical activity
- Medical subject headings
- Osteoporosis, Postmenopausal, Bone Diseases, Metabolic, Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing the PEQ (Personalized Exercise Questionnaire)Other
Administer the questionnaire to 114 participants to classify their facilitators, barriers and preferences to exercise
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the PEQ
This study requires 114 participants for pilot testing of the questionnaire. A subset of 46 patients will be used for the reliability study to determine the test-retest. The questionnaire will be administered at baseline and subsequently completed again after approximately 1 week.
Test-retest will determine the reproducibility of this questionnaire. Intraclass correlation (ICC) model 2, form 2 (ICC 2, 2) will be used.
Internal consistency is expressed by Cronbach's alpha, which is a measure of the reliability of the summative rating scale will also be used.
Measured: 3 months
Known Group-Validity
Known Group Validity is a type of validity that measures the extent to which a questionnaire is sensitive to the differences and similarities between two groups. For example, the investigators may hypothesize that participants from lower socio-economic status (SES) would have cost as a barrier to exercise compared to participants from a higher SES. Hypothesizes will be identified from the literature and tested to determine known group validity.
Differences between hypothesized groups will be assessed using an ANOVA and Chi-Square test.
Measured: 3 months
Secondary outcomes (3)
Preferences to exercise
Using the PEQ, domains two and four, will be used to quantify the frequency of each preference. Results will be presented in a table with column one representing the survey item and column two representing the frequency of the reported outcome.
Measured: 3 months
Barriers to exercise
Using the PEQ, domain six, will be used to quantify the frequency of each barrier. Results will be presented in a table with column one representing the survey item and column two representing the frequency of the reported outcome.
Measured: 3 months
Exercise Goals
Using the PEQ, domain three, will be used to quantify the frequency of each goal. Results will be presented in a table with column one representing the survey item and column two representing the frequency of the reported outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Apr 2017
- Primary completion9 Jul 2017
- Study completion11 Aug 2017
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 Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Rodrigues, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125590
- Sponsor's protocol ID
- 05141991
- Status last verified
- Aug 2017
- First submitted
- 17 Apr 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently, there is no plan, however, if other researchers would like to use this data set they may. Patient names have been changed and associated with an ID. Data sets reveal no patient information.
Publications
Rodrigues IB, Adachi JD, Beattie KA, Lau A, MacDermid JC. Determining known-group validity and test-retest reliability in the PEQ (personalized exercise questionnaire). BMC Musculoskelet Disord. 2019 Aug 14;20(1):373. doi: 10.1186/s12891-019-2761-3.
PubMed 31412834
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity Study of the Facilitators and Barriers Exercise Questionnaire
- ClinicalTrials.gov ID
- NCT03125590
- Acronym / sponsor ID
- 05141991
- Conditions
- Osteoporosis, Postmenopausal, Osteopenia
- Keywords
- Osteoporosis, osteopenia, test-retest, validity, PEQ, questionnaire, facilitators, barriers, exercise, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 9 Jul 2017 (actual)
- Study completion
- 11 Aug 2017 (actual)
- First posted
- 24 Apr 2017 (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 PEQ is the first tool to measure facilitators, barriers, and preferences to exercise in people with osteoporosis.
Detailed description
Osteoporosis is a disease of the bones characterized by low bone mass and microarchitectural deterioration of bone tissue. This disease can increase the risk of bone fragility fractures and is indirectly associated with premature death. These fractures are more common than cancer or heart disease in North American women 50 years or older, with an osteoporotic fracture occurring every 3 seconds worldwide, and are a major issue to patients and the healthcare system. Increased fracture rates, particularly in the hip and spine, may lead to hospitalization and subsequent immobility.
Some studies have shown fitness to be a better predictor of bone mineral density than age, yet adherence to exercise is poor. Studies suggest that 50% of those registered in an exercise program drop out within the first 6 months, lack of time being the number one barrier in many populations. To increase adherence to an exercise program, a systematic review has identified a number of facilitators and barriers to exercise in adults with osteoporosis and osteopenia.
Hitherto, no measurement tool has been created to measure these facilitators and barriers in people with osteoporosis. The investigators have developed and validated the PEQ (Personalized Exercise Questionnaire), a new tool that can measure the facilitators, barriers, and preferences to exercise. The next steps are to test the reliability, known-group validity, and pilot test this tool in the osteoporosis population.
Future physical activity or exercise interventions could benefit from using this tool to leveraging the facilitators and limiting the barriers to exercise to increase adherence to an exercise program.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Peoples with a diagnosis of primary osteoporosis or osteopenia.
Key inclusion criteria (4 listed)
- The participant is able and willing to provide informed consent
- The participant is male or female, 18+
- The participant has received a diagnosis, from a physician, of primary osteopenia or osteoporosis (T < - 1.0)
- The participant can read and write English
Key exclusion criteria (4 listed)
- The participant has been diagnosed with secondary osteopenia or osteoporosis
- The participant has a history of smoking, alcoholism, gastrointestinal disease, hypercalciuria and/or steroid use.
- The participant is diagnosed with a reading disability or dyslexia
- The participant has a cognitive impairment of some severity as to adversely affect the validity of the data
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 |
|---|---|---|
| Testing the PEQ (Personalized Exercise Questionnaire)Administer the questionnaire to 114 participants to classify their facilitators, barriers and preferences to exercise | Other | – |
Primary outcome
Reliability of the PEQ
Time frame: 3 months
This study requires 114 participants for pilot testing of the questionnaire. A subset of 46 patients will be used for the reliability study to determine the test-retest. The questionnaire will be administered at baseline and subsequently completed again after approximately 1 week. Test-retest will determine the reproducibility of this questionnaire. Intraclass correlation (ICC) model 2, form 2 (ICC 2, 2) will be used. Internal consistency is expressed by Cronbach's alpha, which is a measure of the reliability of the summative rating scale will also be used.
Known Group-Validity
Time frame: 3 months
Known Group Validity is a type of validity that measures the extent to which a questionnaire is sensitive to the differences and similarities between two groups. For example, the investigators may hypothesize that participants from lower socio-economic status (SES) would have cost as a barrier to exercise compared to participants from a higher SES. Hypothesizes will be identified from the literature and tested to determine known group validity. Differences between hypothesized groups will be assessed using an ANOVA and Chi-Square test.
3 secondary outcomes
Preferences to exercise
Time frame: 3 months
Barriers to exercise
Time frame: 3 months
Exercise Goals
Time frame: 3 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 Aug 2017.
- Derived from this study: PubMed 31412834Rodrigues IB, Adachi JD, Beattie KA, Lau A, MacDermid JC. Determining known-group validity and test-retest reliability in the PEQ (personalized exercise questionnaire). BMC Musculoskelet Disord. 2019 Aug 14;20(1):373. doi: 10.1186/s12891-019-2761-3.
- Individual participant dataSharing planned: Undecided. Currently, there is no plan, however, if other researchers would like to use this data set they may. Patient names have been changed and associated with an ID. Data sets reveal no patient information.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoporosis, Postmenopausal and Osteopenia, run by McMaster University at 1 site in Canada.
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 4 inclusion and 4 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 Aug 2017. 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 Canada. 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?
Reliability of the PEQ (time frame: 3 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 NCT03125590, 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 29 Aug 2017.