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The effect of intensive muscle strength training and vitamin D supplements in persons with knee osteoarthritis

The effect of high-resistance muscle strength training and vitamin D supplementation in persons with knee osteoarthritis - vitD-EX

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-000047-33-NL
Enrollment
Unknown
Registered
2014-02-24
Start date
2014-03-20
Completion date
Unknown
Last updated
2014-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

knee osteoarthritis vitamin D deficiency

Interventions

Trade Name: Devaron Product Name: Devaron Product Code: Vitamin D Pharmaceutical Form: Tablet INN or Proposed INN: Colecalciferol CAS Number: 67-97-0 Current Sponsor code: Vitamin D Other descriptive

Sponsors

VU University Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Knee pain and at least 2 of the following 5 items: morning stiffness 15nmol/L and =65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

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 co-morbidity - Use of vitamin D supplements >400 IU daily - Living in a nursing home -

Design outcomes

Primary

MeasureTime frame
Secondary Objective: To determine (1) whether high-resistance strength training (70-80% of one-repetition maximum (1RM)) is more effective in improving knee pain, activity limitations, inflammatory markers, falls and fractures, self-reported knee instability and depressive and anxious mood compared to low-resistance strength training (20-30% of 1RM) and (2) whether vitamin D supplementation enhances the effect of muscle strength training on knee pain, activity limitations, inflammatory markers, falls and fractures, self-reported knee instability and depressive and anxious mood. ;Primary end point(s): change in (isokinetic) muscle strength of quadriceps en hamstrings muscles;Timepoint(s) of evaluation of this end point: 6 and 12 months;Main Objective: To determine (1) whether high-resistance strength training (70-80% of one-repetition maximum (1RM)) is more effective in improving muscle strength compared to low-resistance strength training (20-30% of 1RM) and (2) whether vitamin D supplementation enhances the effect of muscle strength training on muscle strength in knee OA patients with vitamin D deficiency. The ultimate goal of the intervention study is to optimize strength training in knee OA, thereby increasing the beneficial effect on pain and activity limitations.—

Secondary

MeasureTime frame
Secondary end point(s): Change in: knee pain, activity limitations (self-report and performance based), inflammatory markers (i.e. C-reactive protein and Erythrocyte Sedimentation Rate), falls and fractures, self-reported knee instability, depression and anxiety. Global perceived effect.;Timepoint(s) of evaluation of this end point: 6 and 12 months—

Countries

Netherlands

Contacts

Public ContactTrial coordinator

Reade

m.vd.leeden@reade.nl0031(0)205896291

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026