Vitamin D as an Intervention for Improving Quadricep Muscle Strength in Patients After Anterior Cruciate Ligament Reconstruction: A Randomized Double-Blinded, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of Biochemical Assays
研究概览
简要总结
Quadriceps muscle strength is one of the key determinants for patients to fulfill the Return-to-Play (RTP) criteria after an anterior cruciate ligament reconstruction (ACLR), in which the muscle size is directly linked to muscle strength. Quadriceps muscle atrophy is unavoidable after ACLR, but the rehabilitation program should increase quadriceps muscle mass. However, despite good rehabilitation compliance, some patient's progress is sub-par and fail to regain muscle mass. Quadriceps muscle atrophy can persist beyond the completion of the rehabilitation program in almost half the patients and the reason behind this is still unknown. This represents an area that requires significant investigation, as quadriceps muscle atrophy and weakness have been shown to be determinants of poor knee function, decreased performance in sports and increased risk of reinjury.
Quadriceps muscle atrophy after ACLR is well documented. This can be due to a decreased ability to regain muscle mass with rehabilitation. Athletes are one of the high-risk groups for vitamin D insufficiencies. Vitamin D deficiency can potentially result in decreased hypertrophy when exercising the muscle, leading to a poorer outcome in rehabilitation. Vitamin D has long been recognized for its effect on musculoskeletal health. It can have a direct effect on muscle hypertrophy by acting on specific vitamin D receptors (VDRs) on myocytes, and sufficient or increased levels of vitamin D in patients have been found to correlate with an increase in the size, number, and strength of muscle fibres. Quadriceps muscle hypertrophy after ACLR is triggered by exercise training, facilitated by diet and a number of intrinsic factors. As the rehabilitation programs and diets are similar in patients with varying extents of quadriceps muscle atrophy, individual responses (intrinsic factors) to exercise training may account for the resulting persistent quadriceps muscle atrophy. In this study, the investigators hypothesize that the deficiency of vitamin D may contribute to persistent quadriceps atrophy and weakness.
With a stringent double-blinded randomized-controlled-trial (RCT) research design, our proposal will then address the research questions: 'Does vitamin D supplements improve the vitamin D deficiency status in patients after ACL reconstruction?', and 'Does vitamin D supplements improve quadriceps muscle strength for patients after ACLR?'
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
It is double blinded, subject will receive either the supplement or the placebo with same appearance and package. The lot number of the bottle will be used for randomization. And the investigators will ask the manufactory about it at the end of the study.
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-40 with unilateral ACL injury
- •Sporting injury with a Tegner score of 7
- •Pre-op serum vitamin D level <20 ng/ml
- •4 months post-ACLR with serum Vitamin D level remained <20ng/ml
- •LSI for quadriceps strength <70% of contralateral leg at 4-month isokinetic assessment
- •Both knees without history of injury/prior surgery
排除标准
- •Concomitant bone fracture, major meniscus injury or full-thickness chondral injuries requiring altered rehabilitation program post-operatively
- •Pre-operative radiographic signs of arthritis
- •Metal implants that would cause interference on MRI
- •Non-HS graft for ACLR
- •Patient non-compliant to the rehabilitation program
- •Regular sunbed users
研究组 & 干预措施
Placebo group
Subject in placebo group will receive one capsule of placebo per day which looks exactly same as the Vitamin D3 capsule with the duration of 16 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Change of Biochemical Assays
时间窗: Pre operation, 4-, 6- 8- and 12months post operation
Blood samples will be taken under non-fasting conditions. Serum / plasma obtained will be immediately stored at -80°C until analysis. Serum 25(OH) Vit-D assay: Serum 25(OH)Vit-D levels will be measured by commercial 25(OH) Vitamin D ELISA kit (Abcam ab213966) according to the manufacturer's instruction, providing the quantitative determination of 25(OH) Vitamin D3 and 25(OH) Vitamin D2. Sensitivity: 1.98 ng/ml (Range: 0.5 ng/ml - 1010 ng/ml).
Change of Isokinetic muscle strength
时间窗: Pre operation, 4-, 6- 8- and 12months post operation
The dynamometer (Biodex System 4, Biodex Medical Systems Inc., New York, USA) will be used for measuring Isokinetic muscle strength in N. Subjects will perform a standardized warm-up exercise (5 min cycling) followed by the test. Concentric/concentric contractions of knee extension/flexion will be tested at 60°/s and 180°/s. Subjects will be seated on the dynamometer chair with their hips flexed to 85°.
次要结局
- Ultrasound imaging muscle thickness(Pre operation, 4-, 6- 8- and 12months post operation)
- MRI Muscle thickness(4- & 8- months post operation)
- International Knee Documentation Committee(Pre operation, 4-, 6- 8- and 12months post operation)
- International Physical Activity Questionnaire(Pre operation, 4-, 6- 8- and 12months post operation)
- Passive Knee laxity(Pre operation, 4-, 6- 8- and 12months post operation)
- Ground reaction force(pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention)
- Visual Analogue Scale(Before and immediate after 1st - 16th of PEMF treatment)
- Knee Joint moments(pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention)
- Change of BMI Anthropometric Measurement(Pre operation, 4-, 6- 8- and 12months post operation)
- Single leg hop distance(4weeks, 8 weeks and 8 months after the commencement of intervention)
- Lysholm knee scoring system(Pre operation, 4-, 6- 8- and 12months post operation)
- Tegner activity score(Pre operation, 4-, 6- 8- and 12months post operation)
研究者
Prof. Tim-Yun Michael ONG
Clinical Assistant Professor
Chinese University of Hong Kong
