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

• ClinicalTrials.gov Identifier: NCT03125590
• Recruitment Status: Completed
• First Posted: April 24, 2017
• Last Update Posted: August 29, 2017
• Sponsor: McMaster University
• Information provided by (Responsible Party): Isabel Rodrigues, McMaster University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Osteoporosis, Postmenopausal; Osteopenia	Other: Testing the PEQ (Personalized Exercise Questionnaire)

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

• Study Type: Observational
• Actual Enrollment: 114 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Reliability and Validity Study of the Facilitators and Barriers Exercise Questionnaire
• Actual Study Start Date: April 1, 2017
• Actual Primary Completion Date: July 9, 2017
• Actual Study Completion Date: August 11, 2017

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. 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.

2. 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.

Secondary Outcome Measures :

1. Preferences to exercise [ Time Frame: 3 months ]
   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.
2. Barriers to exercise [ Time Frame: 3 months ]
   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. Exercise Goals [ Time Frame: 3 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Peoples with a diagnosis of primary osteoporosis or osteopenia.

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

St. Joseph's Health Care Centre; Charlton Site

Hamitlon, Ontario, Canada, L8N1Y2

Sponsors and Collaborators

McMaster University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Isabel Rodrigues, Master's student, McMaster University
• ClinicalTrials.gov Identifier: NCT03125590 History of Changes
• Other Study ID Numbers: 05141991
• First Posted: April 24, 2017
• Last Update Posted: August 29, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Isabel Rodrigues, McMaster University:

Osteoporosis, osteopenia, test-retest, validity, PEQ, questionnaire, facilitators, barriers, exercise, physical activity

Additional relevant MeSH terms:

Osteoporosis; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases