The effect of high-resistance muscle strength training and vitamin D supplementation in persons with knee osteoarthritis |
|- candidate number||17940|
|- NTR Number||NTR4608|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-mei-2014|
|- Secondary IDs||NL47786.048.14 METC|
|- Public Title||The effect of high-resistance muscle strength training and vitamin D supplementation in persons with knee osteoarthritis |
|- Scientific Title||The effect of high-resistance muscle strength training and vitamin D supplementation in persons with knee osteoarthritis |
|- hypothesis||1. High-resistance strength training leads to greater improvements in muscle strength (primary outcome), pain, activity limitations, self-reported knee-instability, falls and fractures, markers for inflammation and depression and anxiety (secondary outcomes) compared to low-resistance strength training.
2. Vitamin D supplementation in combination with strength training leads to greater improvements in muscle strength (primary outcome), pain, activity limitations, self-reported knee-instability, falls and fractures , markers for inflammation and depression and anxiety (secondary outcomes) compared to placebo in combination with strength training.
|- Healt Condition(s) or Problem(s) studied||Knee, Knee osteoarhritis, Arthrosis, Muscle strength, Vitamin D|
|- 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)
|- Exclusion criteria||-Other forms of arthritis than OA (e.g. crystal arthropathy, septic arthritis, spondylarthropathy) identified by radiography and/or blood- and urine samples |
-Absolute contra-indication for exercise therapy/strength training: resting systolic blood pressure of >200mgHG or diastolic blood pressure of >115 mgHG, acute myocardial infarction within the last 3 months, chest pain at rest/ before exercise, other severe cardiac diseases (e.g. present inflammations, symptomatic aortic stenosis, sever cardiac arrhythmias)
-Inability to perform strength training program due to severe co-morbidity
-Total knee arthroplasty (TKA) or TKA scheduled for upcoming year
-Supervised strength training program > 30 minutes/week in past 3 months
-Use of vitamin D supplements >400 IU daily
-Diagnosed with hypercalcemia, hyperparathyroidism or sarcoidosis
-Living in a nursing home
-Inability to be scheduled for therapy
-Insufficient comprehension of Dutch language
-No informed consent
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||7-mei-2014|
|- planned closingdate||6-mei-2018|
|- Target number of participants||220|
|- Interventions||Vitamin D3 1200IU per Day or Placebo
High-resistance strength training or Lowresistance strength training |
|- Primary outcome||Muscle strength of the knee extensors and knee flexors. |
|- Secondary outcome||Knee pain, activity limitations (self-report and performance based), self-reported knee instability/falls and fractures, proprioception, inflammatory markers (i.e. C-reactive protein and Erythrocyte Sedimentation Rate), and depressive and anxious mood. Global perceived effect.|
|- Timepoints||baseline, 3 months, 6 months and 12 months|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. M. Leeden, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Leeden, van der|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background|
As there is currently no cure for OA, conservative treatment is the cornerstone of OA management. Muscle strengthening in particular is a key-target in the conservative treatment of knee OA. In all major international treatment guidelines, exercise therapy (with a dominant role for muscle strengthening) is recommended. However, the optimal training intensity of muscle strengthening exercises in knee OA is not known to date and this is important to maximize patient outcomes from exercise therapy. Based on research in non-OA populations it is expected that high-resistance strength training is more effective than low-resistance strength training to improve muscle strength, without causing serious side effects.
Also, it has been hypothesized that vitamin D supplementation could enhance the effects of exercise therapy on muscle strength, since low serum 25-hydroxy (OH) vitamin D level, which is common in older adults, is associated with impaired muscle cell function. In healthy subjects, indications for a beneficial effect of vitamin D supplementation plus exercise on muscle strength have been found. To improve the effectiveness of strength training in patients with knee OA vitamin D supplementation has the potential to be a useful adjunct.
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 (40-50% 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.
We will conduct a randomized controlled trial with a 2x2 factorial design. Patients with knee OA and
vitamin D deficiency will be randomized into four groups: 1) high resistance strength training and
vitamin D supplementation, 2) high resistance strength training and placebo, 3) low resistance
strength training and vitamin D supplementation, 4) low resistance strength training and placebo.
The power calculation showed that a total of 220 patients are needed. When controlling for repeated
measures, the power calculation showed that a total of 178 patients are needed.
The total intervention period will be 6 months. In the first 3 months, vitamin D tablets (1200IU daily) or placebo tablets will be taken in order to increase the 25(OH) vitamin D level (in case of vitamin D tablets). In the second 3 months, patients will additionally receive a strength training program, including exercises that are primarily aimed at improving quadriceps and hamstrings strength. Both the high-resistance strength training group and the low-resistance strength training group will undergo 3 training sessions per week. In the high-resistance group exercises will be performed with a load of 70-80% of 1 repetition-maximum (1RM) compared to a load of 40-50% of 1RM in the low-resistance group.
Primary outcome measure: upper leg muscle strength. Secondary outcome measures: knee pain, activity limitations, knee instability/falls and fractures, proprioception, inflammatory factors, and depressive and anxious mood. Other measurements: socio-demographic variables, serum 25-hydroxyvitamin D level, health care and medication use, comorbidity, knee alignment, physical activity, body mass index (BMI), compliance and adherence, and side effects. Measurements will be performed at baseline (start of vitamin D supplementation or placebo), at 3 months (start of strength training), at 6 months (post-intervention), and at 12 months (6 months post-intervention).
Intention-to-treat analyses using longitudinal data analyses will focus on establishing the effect of high-resistance relative to low-resistance training and the effect of vitamin D supplementation versus placebo.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Potential participants will be screened with an internet-based (or postal if applicable) questionnaire and by telephone, followed by a screening visit (short physical examination, questionnaire and blood draw). If they pass the screening visit they will be invited to come to Reade for a visit with the rehabilitation physician and rheumatologist for diagnosis and final decision on eligibility. Participants will be measured four times: at baseline, after 3, 6 and 12 months. Participants have to complete questionnaires and perform physical performance tests, and blood and urine will be collected.
The total intervention period will be 6 months. In the first 3 months, vitamin D tablets (1200IU daily) or placebo tablets will be taken. In the second 3 months, patients will additionally receive a strength training program. The risk of the vitamin D treatment is negligible. Strength training is an effective and recommended treatment in patients with knee OA. Risks are minimal, due to supervision of experienced physical therapists and wide experience of the research group in conducting exercise trials in knee OA.
|- Main changes (audit trail)||4-jun-2016:
Exclusion criteria OLD:
-Use of vitamin D supplements >400 IU daily
Exclusion criteria NEW:
-Use of vitamin D supplements >800 IU daily
|- RECORD||23-mei-2014 - 12-feb-2017|
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