Vitamin D to Improve Quadricep Muscle Strength

Official title

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

Overview

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?'

Interventions

• Dietary supplement Vitamin D3
  Subjects will receive 112 capsules with 4 bottles, 28 capsules in each bottle.
• Other Placebo
  Subjects will receive 112 capsules with 4 bottles, 28 capsules in each bottle.

Primary outcome measures

• Change of Isokinetic muscle strength [Time frame: Pre operation, 4-, 6- 8- and 12months post operation]
• Change of Biochemical Assays [Time frame: Pre operation, 4-, 6- 8- and 12months post operation]

Secondary outcome measures (12)

• MRI Muscle thickness [Time frame: 4- & 8- months post operation]
• Ultrasound imaging muscle thickness [Time frame: Pre operation, 4-, 6- 8- and 12months post operation]
• Passive Knee laxity [Time frame: Pre operation, 4-, 6- 8- and 12months post operation]
• Change of BMI Anthropometric Measurement [Time frame: Pre operation, 4-, 6- 8- and 12months post operation]
• Ground reaction force [Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention]
• Knee Joint moments [Time frame: pre PEMF treatment , 4weeks, 8 weeks and 8 months after the commencement of intervention]
• Single leg hop distance [Time frame: 4weeks, 8 weeks and 8 months after the commencement of intervention]
• Visual Analogue Scale [Time frame: Before and immediate after 1st - 16th of PEMF treatment]
• Tegner activity score [Time frame: Pre operation, 4-, 6- 8- and 12months post operation]
• International Knee Documentation Committee [Time frame: Pre operation, 4-, 6- 8- and 12months post operation]
• Lysholm knee scoring system [Time frame: Pre operation, 4-, 6- 8- and 12months post operation]
• International Physical Activity Questionnaire [Time frame: Pre operation, 4-, 6- 8- and 12months post operation]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• The Chinese University of Hong Kong — Hong Kong

Publications

• Ong MT, Lu X, Choi BC, Wan SW, Wang Q, Man GC, Lui PP, Fong DT, Mok DK, Yung PS. Vitamin D as an intervention for improving quadriceps muscle strength in patients after anterior cruciate ligament reconstruction: study protocol for a randomized double-blinded, placebo-controlled clinical trial. Trials. 2024 Apr 11;25(1):251. doi: 10.1186/s13063-024-08094-w. PMID 38605374

Identifiers

NCT: NCT05174611 · 2020.623

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗