NL-OMON44546
Completed
Phase 3
The effect of high-resistance muscle strength training and vitamin D supplementation in persons with knee osteoarthritis - VitD-EX
Jan van Breemen Instituut0 sites288 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- arthrosis deformans
- Sponsor
- Jan van Breemen Instituut
- Enrollment
- 288
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Knee pain and at least 2 of the following 5 items: morning stiffness \<
- •30 minutes, crepitations, bone sensitivity, bony enlargement of the joint
- •margin, no palpable warmth
- •\- Age \>\= 55 and \<\= 80 years
- •\- Vitamin D deficiency: 25(OH)D level \>15nmol/L and \<50 nmol/L (in
- •winter) or \<70nmol/L (in summer);In addition, 68 knee OA patients with normal vitamin D levels will be included in order to study the effect of high versus low resistance strength training. The larger sample size (n\=288\) will lead to more statistical power. Patients with normal vitamin D levels will be randomized into either high or low resistance training, without supplementation with vitamin D or placebo.
Exclusion Criteria
- •\- Other forms of arthritis than OA
- •\- Absolute contra\-indication for exercise therapy/strength training
- •\- Inability to perform strength training program due to severe comorbidity
- •\- Use of vitamin D supplements \>800 IU daily
- •\- Living in a nursing home
Outcomes
Primary Outcomes
Not specified
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