The Impact of Physical Activity and Vitamin D on Osteoarthritic Knee Pain in Older Obese People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Feasibility and acceptability of intervention by qualitative interview
研究概览
简要总结
Knee Osteoarthritis (KOA) is a major cause of pain and disability, particularly in those of increasing age and body fat. As there are no very effective therapies for KOA, disease often progresses until knee replacement surgery is needed. It has been observed Vitamin D and Physical Activity (PA) levels are lower in those with KOA, increased age and body fat. As the relationship between KOA, Vitamin D and PA levels are not clearly understood, this study aims to explore these relationships and the acceptability/feasibility of PA and Vitamin D interventions in those who would likely to benefit from these interventions.
200-300 people, 50-70 years, BMI 30-40kg/m2, meeting American College of Rheumatology (ACR) KOA Guidelines, will be recruited from North Tyneside and Liverpool Hospital trusts November 2014-January 2016 to participate in a single cross-sectional study visit, which will measure: Vitamin D/Calcium serum levels, BMI/Body Fat, mobility, Quality of life and pain (by questionnaire), and PA levels.
Those participants with insufficient Vitamin D levels (25-50nmol/L) and PA levels (<30min moderate PA/week), will be invited to take part in a 3 month pilot RCT study.
>64 people will be recruited for the pilot RCT and equally randomly allocated to 1 of 4 intervention groups: Vitamin D (1 capsule a day: 2000IU), Placebo (identical capsule: 1 a day), PA (online PA programme) and PA and Vitamin D. Additionally at the end of the 12 week study visit, up to 20 participants will be invited to take part in a qualitative interview exploring their experience during the two studies.
详细描述
The primary aim of this project is to test the feasibility and acceptability of increasing PA and Vitamin D supplementation interventions in older, obese people with knee osteoarthritis, with low baseline levels of PA and Vitamin D by performing a 2*2 design pilot randomized controlled trial and a qualitative interview.
The secondary aims of this project is to:
- Explore the relationships between Vitamin D levels, PA levels and KOA pain (using cross-sectional study results)
- Estimate effect sizes and inter-individual variation which can be used in the design of a future definitive RCT.
The project refers to 2 integrated studies:
- Firstly a cross-sectional study to identify individuals with low vitamin D concentrations, low Physical activity levels, who are obese and who meet the ACR KOA criteria for knee osteoarthritis.
- Secondly a pilot randomized controlled trial, which aims to test the feasibility and acceptability of administering vitamin D or placebo capsules and increasing physical activity over a 3 month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CROSS SECTIONAL STUDY
- •Obese: BMI 30-40kg/m2 as defined by WHO criteria
- •Older adults: 50 - 70 years
- •OA of the knee according to ACR Guidelines on symptomatic Knee OA criteria (using history and physical examination:
- •Pain in the knee
- •AND 3 OF THE FOLLOWING:
- •Over 50 years of age
- •Less than 30 minutes of morning stiffness
- •Crepitus on active motion
- •Bony tenderness
- •Bony enlargement
- •No palpable warmth of synovial
- •Good understanding of written and spoken English (as no translation services will be available to this study).
- •PILOT STUDY
- •All of the inclusion criteria for the cross-sectional study (above), plus:
- •Low objectively measured levels of Vitamin D, defined as:
- •Insufficient (25-50nmol/L), excluding deficient (<25 nmol/L), the 25OHD concentration at which symptoms as a result of Vitamin D deficiency commonly occur.
- •Low PA recorded from accelerometers defined as:
- •<30min/week of moderate PA, <15min/week vigorous PA (2*credit of moderate activity) defined as being 'inactive' by UK government guidelines. Activities only counted if they occurred in >10mins bouts. Activity was defined as moderate if it made the participant 'breathe faster, feel warmer or sweat' and increased heart rate. Activities identified as moderate included: brisk walking, cycling, gardening, housework, DIY, climbing stairs and carrying heavy loads.
排除标准
- •CROSS-SECTIONAL STUDY
- •Any other type of arthritic condition, e.g. RA, Fibromyalgia, Ankylosing Spondylitis, Gout, Lupus, Paget's Disease, Polymyalgia rheumatic (PMR), Psoriatic arthritis, Scleroderma, Sjogrens Syndrome
- •Currently taking part in a PA/exercise regime
- •Taking Vitamin D, cod liver oil or Calcium capsules/supplements (topical/oral/intravenous, prescribed/non-prescribed) above 10µg/day of vitamin D and/or 500µg/day of calcium.
- •Taking part in another intervention/trial (depending on researchers discretion)
- •Chronic alcohol abuse (> 21 (women) and 28 (men) SI units/week
- •PILOT STUDY
- •The same exclusion criteria as the cross-sectional study, plus:
- •Conditions which can interfere with Vitamin D supplement adsorption:
- •Malabsorption syndromes: e.g. cystic fibrosis, celiac disease, whipples disease, Crohns Disease, Bypass Surgery, short bowel syndrome,
- •Diagnosed restrictive eating disorder
- •Hypercalcaemia (albumin-adjusted plasma calcium > 2.60 mmol/l)
- •Hypocalcaemia (albumin-adjusted plasma calcium < 2.15 mmol/l)
- •Renal Stage 4-5 Chronic Kidney Disease: GFR < 30 ml/min/1.73m2
- •Primary hyperparathyroidism
- •Conditions which can affect normal baseline levels of vitamin D:
- •Current pregnancy, delivery of child/breast feeding 1 year prior to recruitment
- •Holiday with significant sunlight exposure (specified by list of sunny destinations) in the last 3 months and plans for holidays to sunny/skiing destinations for the duration of the study.
- •Current Anticonvulsant drug therapy
- •Current Glucocorticoid use
- •Current HIV/treatment with Antiretroviral drugs
- •Current anti-oestrogen (aromatase inhibitors, oestrogen receptor inhibitors and selective oestrogen receptor moderators) such as used to treat breast cancers
- •Those currently taking cytostatic/anti-tumour drugs
- •Granulomatous disorders: sarcoidosis, TB, Lymphomas
- •Current conditions which may be made worse/prompts complications of by vitamin D consumption
- •Chronic Renal Disease: stage 4 and 5 (see above)
- •Liver disease
- •Histoplasmosis
- •hyperparathyroidism
- •Hypocalcaemia or hypercalcemia (as defined above)
- •Current/recent (in the last 6 months) supplementation(topical/oral/intravenous, prescribed and non-prescribed) with: Phosphorous, >10µg/day Vitamin D and >500mg/day Calcium
结局指标
主要结局
Feasibility and acceptability of intervention by qualitative interview
时间窗: 1 hour
Qualitative interview with n=20 after last pilot RCT study visit. Interviews will be audio recorded, transcribed and analyzed using a thematic approach using NVivo software to identify main issues.
次要结局
- Objectively measured (by accelerometer) physical activity(3 days)
- Musculoskeletal function measured by Timed up and go test(15 mins)
- Serum vitamin D concentrations measured by Dried Blood Spot sample(10 mins)
- Self reported knee joint pain and function by WOMAC Questionnaire(15 mins)
- Serum vitamin D concentrations measured by venous blood sample(10 mins)
- Body composition measured by Tanita scales(10 mins)
- Waist circumference measured using tape measure(5 mins)
- Quality of life measured using SF-36 Questionnaire(10-15 mins)
- Serum Calcium concentrations measured by venous blood sample(10 mins)
- Height measured by stadiometer(5 mins)