跳至主要内容
临床试验/NCT05671146
NCT05671146已完成不适用

An Evaluation of the Graded Weight-bearing Exercise on Pain, Function, Proprioception, and Muscle Strengths in Patients With Knee Osteoarthritis.

Imam Abdulrahman Bin Faisal University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年12月25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
45
试验地点
2
主要终点
Measurment of pain intensity

研究概览

简要总结

Background: Knee osteoarthritis is the most common disorder impacting the synovial joint. The prevalence of osteoarthritis rises with age, and its consequences on health and socioeconomic are significant, which emphasize the need for clinical and cost-effective treatments for patients with knee OA. Knee OA is a widespread joint arthritis disease combined with many clinical features such as pain, decreased joint proprioception and might lead to loss of function and disability.

Aim: To evaluate the effect of a 6-weeks supervised graded weight-bearing exercise program on pain, function, proprioception, muscle strength in patients with knee osteoarthritis.

Material and Method: Thirty-six patients with chronic knee osteoarthritis with age ranging 40-60 years will be recruited from the physical therapy department and randomized into three groups. Group I: will receive graded weight-bearing exercise using the anti-gravity treadmill combined with open kinetic chain exercises. Group II will receive closed kinetic chain exercises with open kinetic chain exercises while group III will receive open kinetic chain exercises only i.e: stretching and strengthening exercises. The outcome measures will be pain, function, proprioception, and muscle strength.

Statistical analysis: To detect changes in the dependent variables within and between groups, one-way repeated measures Multivariate analysis will be applied. If there is a significant change within groups or between tests, the post hoc Bonferroni test will be used to detect the significance between each group and/or each level of measurement. The level of significance is p<0.05 and confidence interval CI 95%.

Study Design: Single-blinded, randomised control trial.

详细描述

Study design: This study is a single-blinded randomized controlled trial. after baseline assessment, the participants will be assigned randomly into three groups, the graded weight-bearing exercise group, the closed kinetic chain exercise group, and the control group. First, randomization will be performed by allocating a specific number for each participant. Then, Online GraphPad will be applied to randomize these numbers into three groups. The participants' allocation will be conducted by a person who is not in contact with the participants or involved in any testing. The allocation sequence will be saved on that person's computer. Following randomization, the participant will be notified by phone about which group they will be assigned to.

Study setting: The current study will be held at the laboratory at Umm Al-Qura University, Faculty of Applied Medical Sciences, Makkah, Saudi Arabia Recruitment and study population Patients will be recruited from the physical therapy outpatient clinic, Umm Al-Qura university medical centre, and other physical therapy outpatient clinic in Makkah.

Intervention group:

The intervention will be constructed based on recent clinical exercise guidelines for people with knee osteoarthritis. These guidelines mainly recommend weight-bearing exercises, progressive resistance training for lower limb major muscle groups, and aerobic exercise. The exercise regimen will be applied at two sessions per week for six weeks. The intervention is designed as the group I will perform progressive weight-bearing using an anti-gravity treadmill, the loading starts with patient tolerance - pain-free range and increases gradually, combined with open kinetic chain exercises. Group II will perform closed kinetic chain exercises with open kinetic chain exercises. Most of the exercises in these groups will be achieved in a weight-bearing position, with or without support, besides other exercises to improve knee flexors and extensors strength. An experienced physiotherapist will observe the intervention. Participants who have a higher risk of falling, restricted weight-bearing activities, or movement during training and activities will be given extra attention to avoid injuries. The physiotherapists will be trained to deliver the weight-bearing exercise program and ensure that participants have access to support devices. The session will last one hour and be repeated twice a week for six weeks. Participants' customizing, appropriate dosage, and progression of the exercises will be the responsibility of the physiotherapist supervising the exercise session. The exercise regimen will begin with a 10-minute warm-up that includes stretching, flexibility, and dynamic balance exercises. The warm-up will be followed by a graded weight-bearing exercise for group I and a closed kinetic chain exercise for group II with a short break for 30 seconds. Each session will end with 10 min cooling down and stretching. Participants are encouraged to report any significant side effects from the exercise, such as muscular soreness, joint tenderness, or increased pain level.

Control group:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Participant)

盲法说明

knee osteoarthritis

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients had chronic pain in either unilateral or bilateral knees ≥ 6 months.
  • The x-ray showed grades II and III according to on Kallgren and Lawrence (K/L) grading system.
  • Patients are willing to stop medications.
  • Patients accepted to assign informed consent to participate in the current study and will attend the lab twice a week for six successive weeks.

排除标准

  • They have any known significant medical conditions such as hypertension, asthma, cardiac disease, or systemic disease that adversely affect them during testing.
  • Previous knee surgery/injection for the last six months.
  • Previous knee fracture or malignancy.
  • Unable to walk unaided.
  • Unable to commit study requirements.

结局指标

主要结局

Measurment of pain intensity

时间窗: Change from Baseline Pain Intensity at 6 weeks post-intervention

The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line. Zero indicates no pain or discomfort, and 10 indicates the most severe pain. The patient will be asked to mark on the line corresponding to their pain level. For patients with chronic musculoskeletal pain, the VAS is a valid and reliable measure.

Function

时间窗: Change from Baseline Functional level at 6 weeks post-intervention

The function will be measured by WOMAC. The WOMAC index is a sensitive, validated, and reliable measure of knee osteoarthritis impacts such as functional conditions. The WOMAC scale has 17 items used to assess patients with osteoarthritis physical function. The patient's response runs from 1 to 5, with 1 indicating no response and 5 indicating a strong response. The total score will be calculated by adding the scores for each item.

次要结局

  • Proprioception(Change from Baseline Knee Joint Proprioception at 6 weeks post-intervention)
  • Muscle strength(Change from Baseline Quadriceps Muscles strength at 6 weeks post-intervention)

研究者

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

Ammar Fadil

Principle Investigator

Imam Abdulrahman Bin Faisal University

研究点 (2)

Loading locations...

相似试验