Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03125590
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Isabel Rodrigues, McMaster University

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.


Layout table for study information
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

Resource links provided by the National Library of Medicine



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


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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125590


Locations
Layout table for location information
Canada, Ontario
St. Joseph's Health Care Centre; Charlton Site
Hamitlon, Ontario, Canada, L8N1Y2
Sponsors and Collaborators
McMaster University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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    Key Record Dates
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.

Layout table for additional 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:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Osteoporosis, Postmenopausal
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases