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HIGH AND LOW INTENSITY PROGRESSIVE RESISTED EXERCISES ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY

2021年12月30日 更新者:Saiqa Kanwal、University of Lahore

COMPARATIVE EFFECTS OF HIGH AND LOW INTENSITY PROGRESSIVE RESISTED EXERCISES ON PAIN, RANGE OF MOTION AND FUNCTIONAL DISABILITY IN KNEE OSTEOARTHRITIS PATIENTS WITH SARCOPENIA: A RANDOMIZED CONTROLLED TRIAL

The study will be randomized controlled trial. This study will be conducted in University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 84 will be randomly allocated into two experimental groups, (42 participants in each group), by computer generated random number list. The participants,randomly allocated to the experimental group A, will receive high intensity resisted exercises ,in addition with routine physical therapy as TENS (transcutaneous electrical nerve stimulator), Hot pack, Deep friction massage Each session will be of 35-45 minutes with 5 minutes warm up, 35 minutes for training session and lastly 5 minutes for cool down

• Participants in experimental group B, will receive Low intensity resisted exercises in addition with routine physical therapy

研究概览

详细说明

Recruitment: Participants will be recruited and referred by orthopedic doctor, University of Lahore Teaching Hospital to Physical Therapy Department. The study will be randomized controlled trial. This study will be conducted in University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 84 will be randomly allocated into two experimental groups, (42 participants in each group), by computer generated random number list. The participants,randomly allocated to the experimental group A, will receive high intensity resisted exercises ,in addition with routine physical therapy as TENS, Hot pack, Deep friction massage

  • Participants in experimental group B, Low intensity resisted exercises in addition with routine physical therapy
  • Both experimental groups will receive sixteen treatment sessions and those will be given over a period of eight weeks (2 sessions per week, each session of 35-45 minutes with 5 minutes warm up and lastly 5 minutes for cool down in both groups.
  • Outcome measure will be taken by assessor at baseline, and at the end of 8th week (at the end of last treatment session) through Numeric pain rating scale and KOOS
  • Randomization and Allocation: Afterwards, participants confirming the eligibility criteria will be randomly allocated, through computer generated random number list , into two experimental groups (Group A, Group B).
  • Blindness: Study will be single, assessor blinded and an independent investigator will perform randomization and will inform the patients and therapist about the allocation.
  • Intervention: Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.
  • Duration: Sixteen treatment sessions will be given over a period of eight weeks (2 sessions per week, each session of 35-45 minutes).
  • Outcome Variables and Measures

    1. Pain (Numeric pain rating scale)
    2. Functional disability (KOOS)
    3. ROM (Universal Goniometer)
  • Outcome measures will be taken at baseline and at the end of last treatment session i.e. 8th week. Collected data will be than analyzed.

研究类型

介入性

注册 (预期的)

84

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Muhammad Haider Ullah Khan, MS PTN
  • 电话号码:03314127210
  • 邮箱:haiderullah@live.com

研究联系人备份

学习地点

    • Punjab
      • Lahore、Punjab、巴基斯坦、55150
        • 招聘中
        • University of Lahore Teaching Hospital
        • 首席研究员:
          • Saiqa Kanwal, MS-MSK*
        • 副研究员:
          • Syed Asadullah Arslan, PhD
        • 副研究员:
          • Bilal umar, BSPT, DPT,Phd

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

35年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Both genders.
  • Age range between 35-65 years
  • Diagnosed osteoarthritis patients of grade I to III according to kellgren & Lawrence on X-ray (diagnosed by orthopedic specialist)
  • Diagnosed patients with sarcopenia according to SARC-F questionnaire. (diagnosed by orthopedic specialist)

Exclusion Criteria:

  • Patients with history of trauma like RTA(road traffic accident)

    , fall history and other loading injuries, patellar fracture or dislocation.

  • Patients with history of surgery (meniscal reconstruction, TKR(total knee replacement) or Partial Knee Replacement etc.)
  • Patients with severe patellofemoral osteoarthritis.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:High intensity

Intervention: Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.Routine physical therapy including TENS, Hot pack and Deep friction massage along with high intensity exercises will also be delivered along with Muscle Energy Technique. Experimental:High intensity will be treated with high intensity exercises in such a way that

1st and 2nd week; resistance training will be of 50% 1RM with 4 sets of 10 repetitions.

3rd and 4th week: resistance training will be of 70% 1RM with 4 sets of 10 repetitions.

5th and 6th week: the training will be of 80% 1RM with 4 sets of 10 repetitions

Last 4 sessions will be:

7th and 8th week: resistance training will be of 80% 1RM with 5 sets of 10 repetitions.

Intervention:Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.

Both groups will receive routine physical therapy (Tens, Hot pack, Deep friction massage) in addition with experimental interventions

实验性的:Low intensity

Intervention: Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.Routine physical therapy including TENS, Hot pack and Deep friction massage along with Low intensity exercises will also be delivered along with Muscle Energy Technique. Experimental:Low intensity Group B will be treated with low intensity exercise in such a way that,

1st and 2nd week; Resistance training will be of 20% 1RM with 4 sets of 15 reps 3rd and 4th week Resistance training will be of 30% 1RM with 4 sets of 15 reps 5th and 6th week: the training will be of 40% 1RM with 4 sets of 15 reps

Last session will be:

7th and 8th week; Training of 40% 1RM with 5 sets of 15 reps

Intervention:Leg presses, knee extension, hip adduction and hip abduction exercises will be performed by patients. There will be a warm up sets for 1 repetition maximum with 2 min gap between both sets (leg press + knee extension exercises) (hip abduction and hip adduction) patients will ask to perform.

Both groups will receive routine physical therapy (Tens, Hot pack, Deep friction massage) in addition with experimental interventions

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Numeric Pain Rating Scale (NPRS)
大体时间:8 weeks
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain
8 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)
大体时间:8 weeks
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL)
8 weeks
Range of motion
大体时间:8 weeks
Range of motion is the extent of movement of a joint, measured in degrees of a circle. Universal goniometer (UG) will be used to evaluate range of motion (ROM)
8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Saiqa Kanwal, MS-MSK*、University of Lahore

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年11月10日

初级完成 (预期的)

2022年7月8日

研究完成 (预期的)

2022年7月18日

研究注册日期

首次提交

2021年12月30日

首先提交符合 QC 标准的

2021年12月30日

首次发布 (实际的)

2022年1月13日

研究记录更新

最后更新发布 (实际的)

2022年1月13日

上次提交的符合 QC 标准的更新

2021年12月30日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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