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临床试验/NCT07198204
NCT07198204已完成不适用

Effect of Isometric Exercise Duration on Muscle Strength, Pain, and Function in Patients With Knee Osteoarthritis: A Randomized Controlled Trial

University of Hail1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2026年1月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
127
试验地点
1
主要终点
pain by numeric pain rating scale

研究概览

简要总结

this stuy tries to evaulate the best contraction (hold time) during isometric effort that can provide the best therapeutic effects on muscular performance in patients with knee osteoarthritis

详细描述

Knee osteoarthritis (KOA) is a common degenerative disease characterized by the gradual degeneration and loss of joint cartilage, accompanied by bone proliferation. These pathological changes lead to joint pain, stiffness, and limited mobility in affected individuals (Sharma, 2021). The development of KOA, usually associated with various risk factors including age, gender, obesity, genetics, and joint injuries, severely affects patients' quality of life and imposes a heavy economic burden on society (Katz et al., 2021). Research indicates that the global prevalence of KOA has increased significantly since 1990 and is expected to continue rising until 2050, posing a major challenge to global public health.(Steinmetz et al., 2023) Currently, there are various treatment methods for KOA, including pharmacotherapy, surgical treatment, and physical therapy (Duong et al., 2023). Although pharmacotherapy can effectively alleviate symptoms, long-term use may lead to a series of side effects.

Due to its low impact and reduced joint stress, isometric exercise may be more suitable for patients sensitive to joint stress or at higher risk; however, the optimal duration for isometric exercises remains controversial and varies. For instance, Folland et al. compared the strength gains produced by isometric training (with contraction duration of 2 seconds) at four joint angles with conventional dynamic training(Folland et al., 2005). In another study, Kubo et al. investigated the effects of static and dynamic training on the stiffness and blood volume of the human tendon, using a training regimen of 10 contractions of 15-s duration for isometric knee extensions (Kubo et al., 2009). Additionally, Anwer & Alghadir utilized a 5-second duration for isometric quadriceps contractions and hip adduction exercises. In contrast, the Straight Leg Raising (SLR) exercise was maintained for a contraction time of 10 seconds to assess the effects of isometric quadriceps exercises on individuals with knee osteoarthritis.

Understanding the isometric exercise parameters, such as duration, that achieve a desired adaptive response in muscle and tendon would benefit optimizing results. Therefore, the purpose of this study is to compare the effect of isometric exercise duration on muscle strength, pain, and function in patients with KOA.

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
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • prediagnosed case of knee OA as per the American College of Rheumatology (ACR) and radiological evidence of primary osteoarthritis of grade 3 or less on the Kellgren Lawrence scale;
  • age between 40-65 years, including both men and women.
  • unilateral or bilateral involvement (in the case of bilateral involvement, the more symptomatic knee was included).

排除标准

  • Other knee joint pathologies, eg, Chondromalacia patella, plica syndrome,
  • Neurological disorders.
  • Patients having lower extremity injury/surgeries in the past 6 months,
  • Hip or knee fractures or deformity,
  • joint infections and inflammatory joint disease,
  • physical therapy on the knee within the last 3 months or steroid injections,

研究组 & 干预措施

group 1

Experimental

The subjects in this group will perform isometric exercises, including isometric quadriceps, straight-leg raising, and isometric hip adduction exercises for 5 seconds.

All exercises will be performed in sets of 12 repetitions: one set twice a day for the 1st week, which will be progressed weekly until three sets twice a day by 3th week. Allow 5 seconds of rest between each repetition and 3 minutes of rest between sets, with a total contraction time of 60 to 180 seconds per session at 30 to 50% of maximum voluntary contraction (MVC).

干预措施: isometric exercises (Other)

group 3

Experimental

The subjects in this group will perform isometric exercises, including isometric quadriceps, straight leg raising, and isometric hip adduction exercise for 20 sec.

All exercises will be performed in sets of 3 repetitions: one set twice a day for the 1st week, which will be progressed weekly until three sets twice a day by 3th week. Allow 20 seconds of rest between each repetition and 3 minutes of rest between sets, with a total contraction time of 60 to 180 seconds per session at 30 to 50% of MVC.

干预措施: therapeutic ultrasound (Other)

group 1

Experimental

The subjects in this group will perform isometric exercises, including isometric quadriceps, straight-leg raising, and isometric hip adduction exercises for 5 seconds.

All exercises will be performed in sets of 12 repetitions: one set twice a day for the 1st week, which will be progressed weekly until three sets twice a day by 3th week. Allow 5 seconds of rest between each repetition and 3 minutes of rest between sets, with a total contraction time of 60 to 180 seconds per session at 30 to 50% of maximum voluntary contraction (MVC).

干预措施: therapeutic ultrasound (Other)

group 1

Experimental

The subjects in this group will perform isometric exercises, including isometric quadriceps, straight-leg raising, and isometric hip adduction exercises for 5 seconds.

All exercises will be performed in sets of 12 repetitions: one set twice a day for the 1st week, which will be progressed weekly until three sets twice a day by 3th week. Allow 5 seconds of rest between each repetition and 3 minutes of rest between sets, with a total contraction time of 60 to 180 seconds per session at 30 to 50% of maximum voluntary contraction (MVC).

干预措施: Transcutanous electrical nerve stimulation (Other)

group 2

Experimental

The subjects in this group will perform isometric exercises, including isometric quadriceps, straight leg raising, and isometric hip adduction exercise for 10 sec.

All exercises will be performed in sets of 6 repetitions: one set twice a day for the 1st week, which will be progressed weekly until three sets twice a day by 3th week. Allow 10 seconds of rest between each repetition and 3 minutes of rest between sets, with a total contraction time of 60 to 180 seconds per session at 30 to 50% of MVC.

干预措施: isometric exercises (Other)

group 2

Experimental

The subjects in this group will perform isometric exercises, including isometric quadriceps, straight leg raising, and isometric hip adduction exercise for 10 sec.

All exercises will be performed in sets of 6 repetitions: one set twice a day for the 1st week, which will be progressed weekly until three sets twice a day by 3th week. Allow 10 seconds of rest between each repetition and 3 minutes of rest between sets, with a total contraction time of 60 to 180 seconds per session at 30 to 50% of MVC.

干预措施: therapeutic ultrasound (Other)

group 2

Experimental

The subjects in this group will perform isometric exercises, including isometric quadriceps, straight leg raising, and isometric hip adduction exercise for 10 sec.

All exercises will be performed in sets of 6 repetitions: one set twice a day for the 1st week, which will be progressed weekly until three sets twice a day by 3th week. Allow 10 seconds of rest between each repetition and 3 minutes of rest between sets, with a total contraction time of 60 to 180 seconds per session at 30 to 50% of MVC.

干预措施: Transcutanous electrical nerve stimulation (Other)

group 3

Experimental

The subjects in this group will perform isometric exercises, including isometric quadriceps, straight leg raising, and isometric hip adduction exercise for 20 sec.

All exercises will be performed in sets of 3 repetitions: one set twice a day for the 1st week, which will be progressed weekly until three sets twice a day by 3th week. Allow 20 seconds of rest between each repetition and 3 minutes of rest between sets, with a total contraction time of 60 to 180 seconds per session at 30 to 50% of MVC.

干预措施: isometric exercises (Other)

group 3

Experimental

The subjects in this group will perform isometric exercises, including isometric quadriceps, straight leg raising, and isometric hip adduction exercise for 20 sec.

All exercises will be performed in sets of 3 repetitions: one set twice a day for the 1st week, which will be progressed weekly until three sets twice a day by 3th week. Allow 20 seconds of rest between each repetition and 3 minutes of rest between sets, with a total contraction time of 60 to 180 seconds per session at 30 to 50% of MVC.

干预措施: Transcutanous electrical nerve stimulation (Other)

control group

Active Comparator

The control group will receive ultrasound therapy and TENS only.

干预措施: therapeutic ultrasound (Other)

control group

Active Comparator

The control group will receive ultrasound therapy and TENS only.

干预措施: Transcutanous electrical nerve stimulation (Other)

结局指标

主要结局

pain by numeric pain rating scale

时间窗: at baseline and after 1month of trreatment

The Numeric Pain Rating Scale (NPRS) is the simplest and most commonly used numeric scale to rate pain, ranging from 0 (no pain) to 10 (worst pain). The NPRS will be used for subjective pain measurement, which has good test-retest reliability

Function using Western Ontario and McMaster Universities Osteoarthritis

时间窗: will be assessed at baseline and after 1 month of treatement

We will focus only on stiffness and physical function. The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) has been widely used by clinicians in assessing patients with knee OA since it was developed in 1986 (Bellamy, 1995) to evaluate the symptoms of pain, stiffness, and physical function in patients with hip and/or knee OA. It consists of 24 questions and is divided into 3 subgroups: the pain subgroup consists of 5 questions, the stiffness subgroup consists of 2 questions, and the physical function subgroup consists of 17 questions. Each question receives a value between 0 and 4, and the total score is calculated as follows: no difficulty is scored as 0, mild as 1, moderate as 2, severe as 3, and extreme as 4. Higher scores indicate greater physical dysfunction and disability, and thereby worse health-related quality of life

function using Five Times Sit to Stand Test

时间窗: at baseline and after 1month of treatment

The muscle strength of the lower limbs was measured by the Five-Times-Sit-to-Stand Test (FTSST), in which participants rise from a chair and return to a seated position as quickly as possible with their arms folded across their chests. The time to complete five repetitions was recorded for two separate trials, with a 1-minute rest between each trial. The mean of the two trials was computed and used in the analysis

muscle strength using the one-repetition maximum (1RM) test for knee extension

时间窗: at baseline and after 1 month of treatement

1RM test has good-to-excellent test-retest reliability. the participants will be asked to perform active knee extension against different pregressive increasing weigths to determine the 1 RM. 2 minutes rest will be allowed before each contraction effort to allow recovery of the tested muscle.

次要结局

未报告次要终点

研究者

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

Hisham Mohamed Hussein

Associate Professor

University of Hail

研究点 (1)

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