- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07377617
Individualized Education and Exercise on Foot Health (Foot Health)
Effect of Individualized Education and Exercise Program on Foot Health: Randomized Controlled Trial
The purpose of the study is to determine the effect of an individualized education and exercise program applied to nurses on the knowledge, skills and habits of employees regarding foot health. This study is a randomized controlled trial.
The universe of the study will be nurses working in a Training and Research Hospital, and the sample will consist of nurses who agree to participate in the study between the specified dates and meet the criteria. It has been determined that a total of 70 people should be included in the study, 35 in the intervention and control groups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This article will address the following questions:
- How is the foot health of the nurses according to the "self-foot health assessment scale"?
- Is the individualized education and exercise program given to nurses effective on the foot health of employees?
The hypotheses of the study are as follows:
H1: The foot health of the experimental group is more positive than the control group.
H1: The satisfaction levels of the experimental group regarding the foot health program are higher than the control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Yalova, Turkey (Türkiye)
- University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Wanting to participate in the study voluntarily,
- Being a nurse.
Exclusion Criteria:
- Not wanting to participate in the study,
- Not being a nurse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
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Experimental: An individualized education and exercise program
An individualized education and exercise program will be applied to the nurses to improve foot health.
|
An individualized education and exercise program will be applied to the nurses to improve foot health.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performing exercises related to foot health
Time Frame: 6 weeks
|
1. Primary Outcome Measure Outcome Measure Title: Change from Baseline in Self-Foot Health Assessment Instrument (S-FHAI) Score at 6 weeks. Description: The S-FHAI is a self-assessment tool consisting of 22 items across 4 categories: skin health (11 items), toenail health (5 items), foot structure (5 items), and foot pain (2 items). Items are primarily evaluated using "Yes/No" responses, while the final item regarding pain intensity uses a 5-point Likert scale (0=no pain, 4=worst imaginable pain). The total score is used to assess the individual's foot health status. Higher scores indicate different levels of foot health across the specified domains. Time Frame: Baseline and 6 weeks. |
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Musculoskeletal Diseases
- Skin Diseases
- Skin and Connective Tissue Diseases
- Foot Diseases
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- 2024/168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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