跳至主要内容
临床试验/NCT04159883
NCT04159883已完成不适用

The Effect of Using Smart Phone Application for Enhancing Adherence to Home Exercise Program Among Older Adults With Knee Osteoarthritis in Saudi Arabia

King Saud University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年11月14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
40
试验地点
1
主要终点
The self-reported adherence

研究概览

简要总结

Background: Knee osteoarthritis (OA) is a serious condition and requires good adherence to interventions such as exercises to achieve optimal management. The use of smart phone technologies could be such a strategy to enhance adherence to the home exercise program (HEP) thus improve pain, physical function and lower limb strength. The study aimed to examine the effect of using an innovative smart phone app on enhancing the adherence to home exercise programs among female older adults with knee OA in Saudi Arabia and the effectiveness of this HEP which delivered through an app, on pain and physical function. Methodology: 40 females aged 50 years or older with knee OA (20 per study arm) recruited to a randomized control trial that uses a parallel study design. All participants assessed and received an education and a set of a home exercise program for knee OA, Participants randomized into the App arm (experimental group) received their HEP in the smart phone application. Participants randomized to the other arm (control group) received HEP in a paper hand-out. After enrolment, the study outcomes were assessed at week three and week six. The primary outcomes were self-reported adherence, ANPRS, and Ar-WOMAC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female older adults aged 50 and above.
  • Diagnosed with unilateral or bilateral chronic knee OA (diagnosed ≥ six months).
  • Mild to moderate pain intensity (score ≤ 7 on the Arabic Numeric Pain Rating Scale).
  • Ambulate independently.
  • Literate, familiar to use smart mobile phone or tablet.
  • No previous exercising within the last six months.

排除标准

  • Comorbidities that affect their health and wellness (neurological conditions, unstable cardiopulmonary conditions, mental disorders with score < 24 on Mini-Mental State Examination)
  • Waiting for surgical intervention.
  • Recent trauma (fall/ accident).

结局指标

主要结局

The self-reported adherence

时间窗: 6 weeks

Adherence rate obtained as a percentage of the exercise done out of the total number of prescribed exercises. The self-reported adherence is a self-report, all the participants received an exercise log and asked to check on the date of the completed exercise. To calculate adherence, the total number of done exercises for each participant was divided by 84 and 182, which were the total number of prescribed exercises for the 3rd and 6th week period respectively.

The Arabic Numeric Pain Rating Scale (ANPRS)

时间窗: Change from baseline pain score at 6 weeks

Pain intensity over the previous week evaluated with The Arabic Numeric Pain Rating Scale (ANPRS) which is a reliable and valid scale for assessing pain in knee osteoarthritis. It is a 0 to 10 numerical rating scale in which "0" indicates "no pain" and "10" indicates "worst pain".

The Arabic version of the reduced WOMAC index (ArWOMAC)- Function sub-scale

时间窗: Change from baseline functional score at 6 weeks

Used to assess the physical function. It is reliable and valid measure for assessing the severity of knee OA in term of pain and physical function. The reduced ArWOMAC has two subscales and twelve elements in total, the pain subscale includes five elements and the physical function subscale includes seven elements. Likert-scale is applied where the response of each element comes with five levels showing varying intensity degrees that range from 0 to 4, where four is assigned for "extreme" and 0 assigned for "none". The analysis entails collecting and summing up the scores for elements in both subscales to get the total scores (for pain 0-20, for function the scores are 0-28

次要结局

  • The Five-Times Sit-To-Stand Test (FTSST)(Change from baseline strength score at 6 weeks)

研究者

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

Maryam Mohammed Alasfour

Principal Investigator

King Saud University

研究点 (1)

Loading locations...

相似试验

The Effect of Using Smart Phone Application for... | 临床试验