Research on Influencing Factors of Compliance of Spinal Exercise Therapy

July 4, 2021 updated by: Peking University Third Hospital
Explore the many factors that affect the compliance of home exercise therapy in patients with non-specific chronic low back pain, establish a theoretical model of the factors affecting compliance behavior, in order to guide rehabilitation clinical practice, and improve the compliance of patients with non-specific chronic low back pain to home exercise prescriptions.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Research on Influencing Factors of Compliance of Spinal Exercise Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

From February 2019 to August 2019, due to recurrent low back pain, he was treated in the Department of Rehabilitation Medicine of Peking University Third Hospital and prescribed home exercise therapy.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Family-Based
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
Follow-up by telephone for researching compliance of patients receiving exercise prescriptions
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
main result 1
Time Frame: 8 weeks after receiving treatment
The number of patients with good compliance;
8 weeks after receiving treatment
main result 2
Time Frame: 8 weeks after receiving treatment
the number of patients with poor compliance
8 weeks after receiving treatment
main result 3
Time Frame: 8 weeks after receiving treatment
Self-made scale scores in 8 dimensions
8 weeks after receiving treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

July 4, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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