跳至主要内容
临床试验/NCT02290275
NCT02290275已完成不适用

Creatine, Exercise and Inflammatory Markers in Knee Osteoarthritis

University of Manitoba2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
C-reactive protein

研究概览

简要总结

The goal of this research project is to determine the effectiveness of creatine supplementation and supported low-load walking exercise for managing systemic inflammatory biomarkers and joint symptoms in individuals diagnosed with chronic symptomatic knee osteoarthritis. The central hypothesis of this investigation is that creatine supplementation and exercise will significantly lower systemic biomarkers of inflammation in patients diagnosed with knee osteoarthritis.

详细描述

Participants will provide informed consent, complete participant information and knee demographic forms, and undergo radiographic evaluation to confirm eligibility. Baseline evaluation of (1) systemic inflammation; and (2) knee joint pain and function will be completed. Following baseline evaluation, participants will be randomly assigned to 1 of 3 groups using online software available at http://www.randomizer.org/:

  1. Exercise group: Participants will exercise for 30 minutes under low-load walking conditions 3x per week for 12 consecutive weeks on a Lower Body Positive Pressure (LBPP) treadmill (Alter-G Inc - Menlo Park, CA) at a set speed of 3.1 mph at 0⁰ incline. The initial five minutes of each exercise session will be used as a warm-up to allow the participant to reach their target heart rate, to accommodate to walking on the treadmill's belt surface, and to facilitate adjustment of the LBPP within the treadmill's air chamber to a percentage of unweighting that eliminates or substantially reduces the participant's acute knee pain for the duration of the 30 minute walking session. Subjects will be blinded to the amount of LBPP used to un-weight them during each low-load walking session.
  2. Creatine group: Participants will supplement their regular diet with creatine monohydrate for 12 consecutive weeks. In week #1, participants will ingest 5 grams of creatine monohydrate 4x per day for a total ingestion of 20 grams per day. For the remaining 11 weeks, participants will consume 5 grams of creatine monohydrate per day to maintain the increased concentration of creatine.
  3. Placebo group: Participants in the placebo group will supplement their regular diet with maltodextrin (an inert sugar based molecule) for 12 consecutive weeks. In week #1, participants will ingest 5 grams of maltodextrin 4x per day for a total ingestion of 20 grams per day. They will then ingest 5 grams of maltodextrin per day for the remaining 11 weeks.

All data collection will take place at the Pan Am Clinic, a multidisciplinary tertiary care hospital and research facility that serves as the Winnipeg Regional Health Authority's "Centre of Excellence for Musculoskeletal Injury Assessment and Treatment". This project will utilize the combined assets of University of Manitoba and Pan Am Clinic to access medical resources that are used on a daily basis for the diagnosis, treatment, and long term management of patients with knee OA. All participants will undergo follow-up evaluation 13 weeks after their initial baseline evaluation.

Aim #1: Determine if knee OA systemic inflammation is significantly decreased following completion of a 12 week creatine supplementation or low-load treadmill walking exercise regimen.

Hypotheses:

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) Ages 45-65; (2) Body mass index (BMI) over 25 kg/m2; (3) Knee pain when performing normal activities of daily living (walking, squatting, or kneeling); (4) Kellgren & Lawrence grades II & III radiographic evidence of mild to moderate knee osteoarthritis in one or both knees.

排除标准

  • (1) Radiographic evidence of severe knee osteoarthritis; (2) History of traumatic hip, knee, or ankle injury or surgery; (3) Use of crutches or a walking aid during ambulation; (3) History of medical conditions that prevent physical activity; (4) Unable to provide consent due to language barrier or mental status; (5) History of diabetes, cardiovascular disease, or screen positive for ankylosing spondylitis, psoriatic arthritis, chronic reactive arthritis, or renal problems requiring peritoneal dialysis or hemodialysis; (6) Unwillingness or inability to return for follow-up appointments.

结局指标

主要结局

C-reactive protein

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Stephen Mark Cornish

Assistant Professor

University of Manitoba

研究点 (2)

Loading locations...

相似试验