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临床试验/NCT06589960
NCT06589960已完成不适用

Effect of Lifestyle Modification on Patients with Knee Osteoarthritis Attending NRC Rheumatology Clinic

National Research Centre, Egypt1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Assess the symptoms and physical disability, monitor the course of KOA, and determine the effectiveness of a variety of interventions

研究概览

简要总结

This is a cross-sectional study carried out on 180 Knee osteoarthritis (KOA) patients who were consecutively recruited from the Rheumatology Outpatient Clinic at National Research Center (NRC), Egypt. A face-to-face interview was carried out to collect data about demographic data, medical history, and Knowledge, Attitude and Practice (KAP). Assessment of symptoms, disease severity, and physical disability was carried out using Western Ontario and McMaster Universities Arthritis Index (WOMAC). Quality of life was also assessed using Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) questionnaire. The studied participants were subjected to clinical examination and anthropometric measurements and a blood sample was collected from them to measure inflammatory biomarkers Interleukin-6 (IL-6). Then a health education and physical exercise were done. An Educational Booklet was designed and distributed to the studied patients. WOMAC, OAKHQOL, and KAP questionnaires were used to assess the effect of health education and lifestyle modification on the participants.

详细描述

I) Pre-intervention was done by:

  1. Sociodemographic questionnaire: to gather information regarding participants age, gender, marital status, occupation, level of education, smoking habits, duration of the disease, medical history and medications taken.
  2. Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) questionnaire: The OAKHQOL is a specific tool to measure QOL in knee and hip OA as it takes into account specific themes that are exclusive to the QOL of patients with knee and hip OA (social support, sleep, side effects of drugs, plans for the future, embarrassment to be seen by people, use of public transport, difficulty in moving after staying in the same position, and sexuality). The concept of this questionnaire was based on the World Health Organization definition of QOL. It is a self-administered questionnaire the original questionnaire was developed in French and later in English, while in the current study, it was translated by the researcher into the Arabic language. It has 43 items which fall into five domains: physical activity (16 items), mental health (13 items), pain (4 items), social support (4 items), social functioning (3 items), and three items are independent. Response to all items is by a Numerical Rating Scale (NRS) (0-10). A total score for each subscale is calculated by averaging the values for items of the same dimension and is normalized to a score from 0 (worst HRQOL) to 100 (best HRQOL). Evaluation of the OAKHQOL has shown the reliability of the five domains to be satisfactory (interclass correlation coefficients: 0.70-0.85), the construct validity to be adequate (Spearman correlation coefficients: 0.43-0.75), and the discrimination to be satisfactory (Rat et al, 2006).
  3. Western Ontario and McMaster Universities Arthritis Index (WOMAC): WOMAC is a disease-specific, self-administered health status measure that is widely used to assess the symptoms and physical disability for people with knee and/or hip OA. WOMAC has been translated into more than 65 different languages worldwide, in the current study it was translated by the researcher into the Arabic language, it has been validated for usage via telephone interviews, multimedia with audio-visual presentations, verbally spoken computer programs, and mobile phone applications. It is widely used in OA research especially to monitor the course of the disease or to determine the effectiveness of a variety of interventions (pharmacologic, surgical, physiotherapy etc.). It provides an excellent look at a patient's functional capacity and complements the more objective data provided by magnetic resonance imaging, arthroscopy, cartilage biopsy, and radiographs. It consists of 24 items divided into three subscales:
  • Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright
  • Stiffness (2 items): after first waking and later in the day
  • Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.

The Index is available in 5-point Likert (LK), 100mm visual analog (VA), and 11-point numerical rating (NR) scaling formats. On the Likert scale, each question had five alternatives where 0=no constraints or difficulties, 1 = slight, 2=moderate, 3=severe, 4= extreme. The highest score for each subscale on WOMAC on the Likert scale was 20 for pain, 8 for stiffness and 68 for physical function. The highest total score (96) denotes worse or more symptoms and the strongest physical constraints. 4. Knowledge, Attitude and Practice (KAP) questionnaire: to identify participants' knowledge about OA (what is KOA, symptoms, possible risk factors, complications, how to delay progression, management choices, and side effects), attitude towards non-surgical interventions and practices (nutritional habits, physical activity, treatment, and positions that worsen the condition or protect the knees). 5. Clinical assessment: the studied participants were subjected to clinical examination and anthropometric measurements (body mass index, waist and hip circumference). 6. Preintervention assessment of concentration of serum biomarker (IL-6) : A blood sample of 3cm was collected from all the participants after 12- hours fasting (to avoid the inflammatory effect of food) to measure inflammatory biomarkers (IL-6). This assessment was done on a sub sample of participants according to certain circumstances (as not receiving anti-inflammatory drugs in in the past 3 months and those who were adherent to the program of health education).

II) Health Education program Implementation: Nine educational sessions were held. In each session, 10-15 participants attended with total number of 109 participants. The session took 120 minutes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
36 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •KOA patients from both sexes.
  • •Age above 35 years old.
  • •One/both knee joint affection.

排除标准

  • •Other causes than OA for joint problems (e.g. hip fracture, chronic widespread pain, acute inflammatory joint disease, or cancer).
  • •Patients receiving physical therapy or intra-articular injection in the past 3 months.
  • •Total joint replacement or other surgery of the knee or hip within the past 3 months.
  • •Immunosuppressant intake in the past 3 months.
  • •Pregnancy, end stage disease or malignancy.

研究组 & 干预措施

Intervention

Experimental
  • Health education
  • Physical exercise

干预措施: Health education and physical exercise (Combination Product)

结局指标

主要结局

Assess the symptoms and physical disability, monitor the course of KOA, and determine the effectiveness of a variety of interventions

时间窗: 6 months

A Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a disease-specific, self-administered health status measure that is widely used. In the current study, WOMAC was translated by the researcher into the Arabic language. It consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), physical Function (17 items). The Index is available in 5-point Likert (LK), where 0=no constraints or difficulties, 1=slight, 2=moderate, 3=severe, 4= extreme. The highest score for each subscale on WOMAC on the Likert scale was 20 for pain, 8 for stiffness and 68 for physical function. The highest total score (96) denotes worse or more symptoms and the strongest physical constraints.

Measure QOL in KOA and assess the effect of health education and lifestyle modification

时间窗: 6 months

An Osteoarthritis Knee and Hip Quality of Life questionnaire (OAKHQOL) is a specific tool. In the current study, it was translated by the researcher into Arabic language. It has 43 items which fall into five domains: physical activity (16 items), mental health (13 items), pain (4 items), social support (4 items), social functioning (3 items), and three items are independent. Response to all items is by a Numerical Rating Scale (NRS) (0-10). A total score for each subscale is calculated by averaging the values for items of the same dimension and is normalized to a score from 0 (worst HRQOL) to 100 (best HRQOL).

Identify knowledge about KOA

时间窗: 6 months

Knowledge, Attitude and Practice (KAP) questionnaire to identify participants' knowledge about KOA: what is KOA, symptoms, possible risk factors, complications, how to delay progression, management choices, and side effects.

Identify attitude about KOA

时间窗: 6 months

Knowledge, Attitude and Practice (KAP) questionnaire to identify attitude towards non-surgical interventions.

Identify practices about KOA

时间窗: 6 months

Knowledge, Attitude and Practice (KAP) questionnaire to identify practices: (nutritional habits, physical activity, treatment, and positions that worsen the condition or protect the knees) and to assess the effect of health education and lifestyle modification on the participants.

次要结局

  • Sociodemographic data(2 months)
  • Clinical assessment(2 months)
  • Measuring waist circumference(2 months)
  • Measuring hip circumference(2 months)
  • Serum IL-6 concentration assessment(2 months)
  • Measuring body mass index(2 months)

研究者

发起方
National Research Centre, Egypt
申办方类型
Other
责任方
Sponsor

研究点 (1)

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