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临床试验/NCT03125590
NCT03125590已完成不适用

Reliability and Validity Study of the Facilitators and Barriers Exercise Questionnaire

McMaster University1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
1
主要终点
Reliability of the PEQ

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

Reliability of the PEQ

时间窗: 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

时间窗: 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.

次要结局

  • Exercise Goals(3 months)
  • Preferences to exercise(3 months)
  • Barriers to exercise(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabel Rodrigues

Master's student

McMaster University

研究点 (1)

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