An Evaluation of the Graded Weight-bearing Exercise in Patients With Knee Osteoarthritis.
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

      Participants assigned to the control group will receive open kinetic chain exercises only,
      including stretching and strengthening exercises for knee flexors and extensors. They will be
      expected to maintain their current level of physical activity and go about their daily lives
      as usual.

      Adherence:

      The percentage of total intervention days completed will be used to determine adherence. 12
      sessions = 100%.

      Sample size estimation: A G-power grogram for windows is used to calculate the estimated
      sample size with an effect size of 0.25 and an alpha error probability of 0.90 to detect the
      changes in three groups receiving three independent interventions for four dependent
      variables. The measurement will be repeated twice across the study period. The statistical
      test used is the Multivariate Analysis of variance (MANOVA), and the total sample size will
      be 36. The number will be increased for possible dropout to 45 patients with 15 patients in
      each group. Statistical Analysis The study's findings will be presented in accordance with
      CONSORT.

      Statistical analysis: will be carried out with the help of statistical software such as SPSS.
      Patients' demographic data will be presented as mean and standard deviation. Analysis of the
      patients' age (years), weight (Kg), height (cm), and body mass index (BMI) kg/m2 will be
      performed by one-way analysis of variance (ANOVA) to detect the similarity in subjects
      between the treatment groups. Three treatment groups that received three different
      interventions will be measured twice at pre-treatment and post-treatment. To detect changes
      in the dependent variables within and between groups, one-way repeated measures Multivariate
      analysis (MANOVA) 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. The data will be
      analyzed with the intention to treat principles. Each paper from the project will be
      subjected to a statistical analysis publication plan.
    

Intervention name(s): anti-gravity treadmill; Weight-bearing exercises for knee flexors and extensors; Non weight-bearing exercises for knee flexors and extensors
Intervention type(s): Device; Other; Other
Intervention description(s): participants will perform exercises with partial weight-bearing by using an anti-gravity treadmill; Stretching and strengthening exercises will be performed in a weight-bearing position; Stretching and strengthening exercises will be performed in a non-weight-bearing position
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Graded weight-bearing exercise; Anti-gravity treadmill