Validation, Reliability and Pilot Test of the Personalized Exercise Questionnaire (PEQ)

Osteopenia Clinical Trial

Official title:

Reliability and Validity Study of the Facilitators and Barriers Exercise Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125590
• Other study ID #: 05141991
• Status: Completed
• Phase: N/A
• First received: April 17, 2017
• Last updated: August 28, 2017
• Start date: April 1, 2017
• Est. completion date: August 11, 2017

Study information

• Verified date: August 2017
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The PEQ is the first tool to measure facilitators, barriers, and preferences to exercise in people with osteoporosis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 11, 2017
• Est. primary completion date: July 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The participant is able and willing to provide informed consent

2. The participant is male or female, 18+

3. The participant has received a diagnosis, from a physician, of primary osteopenia or osteoporosis (T < - 1.0)

4. The participant can read and write English

Exclusion Criteria:

1. The participant has been diagnosed with secondary osteopenia or osteoporosis

2. The participant has a history of smoking, alcoholism, gastrointestinal disease, hypercalciuria and/or steroid use.

3. The participant is diagnosed with a reading disability or dyslexia

4. The participant has a cognitive impairment of some severity as to adversely affect the validity of the data

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Other:
• Testing the PEQ (Personalized Exercise Questionnaire)
Administer the questionnaire to 114 participants to classify their facilitators, barriers and preferences to exercise

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care Centre; Charlton Site	Hamitlon	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months