- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04962282
Research on Influencing Factors of Compliance of Spinal Exercise Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
ABSTRACT Objective: To achieve more information and establish better guidance for the clinical practice of rehabilitation, to improve the adherence of non-specific chronic low back pain patients with home-based exercise prescription by exploring the factors that affect the adherence of patients, and by building a theoretical model of adherence influencing factors.
Method: From February 2019 to August 2019, 39 patients were diagnosed as non-specific chronic low back pain and prescribed home-based exercise prescription in the Department of rehabilitation medicine of Peking University Third Hospital. They were recruited by criterion-based sampling and had face-to-face exercise therapy guidance from the same physiotherapist. We have a semi-structured 20-40 minutes telephone interview 2-3 months later. The conversation was recorded with the consent of the patients, then the recorded content was documented as text data. By the patient's exercise type, intensity, duration and frequency, the patient adherence was classified as complete adherent, partial adherent and complete not adherent. The qualitative research method was used to analyze the data under the guidance of grounded theory with the help of qualitative analysis software NVivo. NVivo was used to encode the text data of patient's conversation in three levels, and the themes were extracted to explain the causes of adherence.
Result: Of the 39 patients interviewed, 32 responded to the interview, with a response rate of 82.0%. The average age of these 32 responded patients was 48.8±18.6 years old. There were 9 males (28.1%) and 23 females (71.9%). There were 4 complete adherent patients, 5 not adherent, and 23 partial adherent (including 14 giving up halfway and 9 intermittent exercise). The open coding got 19 initial sub-categories; then axial coding classified 19 initial sub-categories into five main categories, namely health belief, self-efficacy, exercise prescription, self-management and family support. Selective coding classified health belief and self-efficacy as "internal environment", while exercise prescription and family support as "external environment". Based on this discovery, two theories are established: (1) patients' "self-management" ability is the internal motivation of adherence behavior; (2) the "internal environment" and "external environment" play a regulatory role in adherence behavior.
Conclusion: Patients' adherence behavior is directly affected by the ability of self-management and tends to be standardized under the regulation of good internal and external environment. Regular follow-up, health education and adjusting the structure of exercise prescription are necessary measures to improve patients' adherence.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100191
- Recruiting
- Research on Influencing Factors of Compliance of Spinal Exercise Therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1.Age from 18 to 80 years old; 2.The clinical diagnosis is non-specific low back pain, the course of disease is ≥12 weeks;
Exclusion Criteria:
- 1.Combined with specific lumbar spine diseases, physical diseases affecting sports 2.Due to mental or psychological abnormalities; refused to accept telephone interviews; 3.Failed to answer the interview call for 3 consecutive times;
Study Plan
How is the study designed?
Design Details
- Observational Models: Family-Based
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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group 1
Follow-up by telephone for researching compliance of patients receiving exercise prescriptions
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Studies have shown that the compliance of patients at 8-12 weeks reaches a peak, so this time node is the most suitable time node to investigate compliance.
Telephone follow-up is irreplaceable convenience, so the telephone follow-up survey of patient compliance with exercise prescriptions is The most feasible method The purpose of the telephone follow-up is to 1. Investigate the compliance of the patients; 2. Make the patients fill out a self-made research compliance scale influencing factors through the telephone.The purpose of the telephone follow-up is to 1. Investigate the compliance of the patients; 2. Make the patients fill out a self-made research compliance scale influencing factors through the telephone.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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main result 1
Time Frame: 8 weeks after receiving treatment
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The number of patients with good compliance;
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8 weeks after receiving treatment
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main result 2
Time Frame: 8 weeks after receiving treatment
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the number of patients with poor compliance
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8 weeks after receiving treatment
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main result 3
Time Frame: 8 weeks after receiving treatment
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Self-made scale scores in 8 dimensions
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8 weeks after receiving treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2019385
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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