跳至主要内容
临床试验/CTRI/2024/01/061127
CTRI/2024/01/061127尚未招募2 期

The Effect of a Structured Home Based Exercise Program on the Functional Outcome in Patients with Knee Osteoarthritis and its Predictors for Successful Outcome

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
6 minute walk test

研究概览

简要总结

Knee OA is a leading cause of functional limitation among older adults. There are a number of treatment options available, both pharmacological and non-pharmacological, in combination. Non-pharmacological treatment options include exercises, physical modalities, orthoses, interventions or surgery (at late stages).

Exercises are known to be associated with better outcomes when supervised, which is not practical at most times. So, a proper structured home-based exercise  program might be more practical in these patients. These measures are believed not only to reduce pain, but also improve the functional outcome of the patients. Hence, we want to know the functional outcomes of a proper structural home based exercise in Knee Osteoarthritis patients.

Also various factors are known to affect the response to the available treatments for individuals with Knee OA. An understanding of such predictors for a successful outcome will help to provide a broader perspective to health practitioners. Thus, we will also try to find predictors for successful outcomes in these patients.

Allpatients coming to AIIMS, PMR-OPD with the complaint of knee pain will bethoroughly examined after taking detailed history for possibility of enrollingin the study. Those who have Knee OA as per revised ACR criteriafor early diagnosis of Knee OA, will be advised plainX ray of knee AP (weight bearing position) and skyline view to know theseverity as per Kellgren & Lawrence (KL) grading.  All patients with KL Grades of OA knee (TF)including those waitlisted for surgery more than 8 weeks, will be enrolled inthe study after ruling out the exclusion criteria and after taking awritten informed consent.

Afterenrolling in the study, all patients will be required to undergo a triple phasebone scan with single-photon emission computed tomography-computed tomography(SPECT/CT).

Allpatients will also be asked to do a 6MWT to note down the distance walked bythe patient in 6 minutes, which will indicate the status of function. Allenrolled patients will also be asked to fill up the KOOS questionnaire.

The structured exerciseprogram will comprise of aerobic/warm-up, strengthening exercises (quadriceps,hip extensors and hamstrings), stretching exercises (tendoachilles, hamstrings,quadriceps) and neuromuscular control exercises. After 2 weeks, allparticipants will be given a telephone call to reinforce the exercises andother advices, as well as to find out if they have any issues/doubts. They willbe followed up physically after 4 weeks and will be required to undergo another6MWT and to fill up the KOOS questionnaire. Last follow up will be done at theend of 8 weeks where 6MWT and KOOS questionnaire filling up is again done. APatient Global Impression of Change (PGIC) will also be asked to be filled upby the patient at 8 weeks to know their overall status since the start of thestudy. Categories of ’very much improved’ and ’much improved’ in PGIC will beconsidered as successful outcome in our study.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •Diagnosed case of OA knee as per ACR revised Criteria for early diagnosis of knee OA
  • •All Kellgren & Lawrence grades of OA knee (TF) including those waitlisted for surgery for more than 8 weeks.
  • •Patient of either sex and age > 40 years
  • •Ability to comprehend Hindi or English and follow commands.

排除标准

  • •H/o surgical intervention in lower limbs.
  • •H/o lower limb fractures.
  • •Other lower limb osteoarthropathy (RA or other joint disease)
  • •Any other disabling conditions (e.g. back pain or widespread pain)
  • •Neurological disease.
  • •History of knee intraarticular injections (steroid, PRP, hyaluronic acid etc) past 2 months.
  • •Secondary Knee OA
  • •Patient with Cognitive difficulties
  • •Patients contraindicated to perform 6 MWT(eg.
  • •Unstable angina/MI in past 1 month).

结局指标

主要结局

6 minute walk test

时间窗: At Baseline, 4th week and 8th week

次要结局

  • Knee Injury & Osteoarthritis Outcome Scale(At Baseline, 4th week & 8th week)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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