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临床试验/NCT01886196
NCT01886196已完成不适用

Ibuprofen Supplementation After Resistance Training and Its Effects on Bone in Older Women

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
change from baseline in aBMD of the proximal femur and lumbar spine at 9 months

研究概览

简要总结

Inflammation increases with aging and is implicated in the reduction of bone mass, muscle mass, and strength. Resistance training is safe and effective for increasing muscle mass and strength in older adults,however resistance training by itself cannot suppress inflammation. Ibuprofen is a non-steroidal anti-inflammatory drug that may provide benefits to muscle mass and strength when given after resistance training sessions in older adults; however, more evidence is required to confirm effects across the lifespan. The objectives are to determine the effect of 9 months of exercise training and ibuprofen supplementation, compared to placebo, in older women (≥65years)on the following dependent variables:

  • bone density, geometry, and architecture
  • muscle mass and strength
  • balance

详细描述

The aim of our study is to create new evidence about the effectiveness and safety of non-steroid anti-inflammatory supplementation (i.e. ibuprofen) combined with exercise to influence positively bone and muscle health in women aged 65 years and older. With aging, there is a significant decrease in bone mineral, muscle mass, and strength, which increases the risk of falls, injuries and fracture especially for women. Direct and indirect health costs associated with osteoporosis and sarcopenia (defined as "muscle wasting") are in the billions of dollars and escalating as the proportion of older adults in Canada grows. Low-grade inflammation is a main contributing factor to bone and muscle deterioration with aging but is mitigated by anti-inflammatory drug use. Recent evidence shows resistance exercise training combined with a non-steroidal anti-inflammatory drug (ibuprofen) is effective for increasing bone mineral density in young women. No study has addressed directly the effects of ibuprofen use following resistance exercise on bone and muscle in older women, the population at greatest risk of developing osteoporosis. The primary purpose of this study is to investigate the safety and multiple effects of ibuprofen ingestion following supervised resistance exercise training on bone and muscle in older women (≥65y).

PRIMARY HYPOTHESES: Ibuprofen combined with resistance training will maintain hip and lumbar spine areal bone mineral density in older women. Secondary hypotheses are that bone structural properties in the hip and wrist, and muscle mass and strength will be improved by supplementing ibuprofen after resistance training sessions.

RESEARCH PLAN: The study will use a repeated measures, parallel group randomized design where 100 women (≥65 y) will be randomized to one of 4 groups: 1) Exercise and ibuprofen (400 mg immediately after exercise); 2) Exercise and ibuprofen placebo; 3) Placebo exercise and ibuprofen, 4) Placebo exercise and ibuprofen placebo. Women will participate in the exercise sessions 3 days per week. The intervention will be 9 months in duration. Dual energy X-ray absorptiometry (DXA) will be used to assess hip and lumbar spine areal bone mineral density, as well as geometric changes in hip structure, and whole body lean tissue (i.e. muscle) mass. Peripheral quantitative computed tomography (pQCT) and high-resolution-pQCT will allow us to investigate detailed changes in bone microarchitecture at the wrist and muscle cross-sectional area in the forearm in response to the intervention. Safety will be addressed by closely monitoring adverse events.

RELEVANCE: This pilot study potentially drives a novel post-market use of ibuprofen. In addition, it permits our developing research team a foray into preliminary data collection to inform a larger randomized controlled trial (RCT) application to CIHR.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women >65yrs

排除标准

  • high risk of fracture
  • use of bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators, PTH, or calcitonin within the past 12 months
  • taking medications that affect bone mineral metabolism
  • have diseases that are known to affect bone mineral metabolism
  • have severe osteoarthritis
  • currently a smoker
  • currently participating in moderate-vigorous resistance-exercise training more than once per week

研究组 & 干预措施

placebo

Placebo Comparator

placebo after exercise training sessions(3 times per week for 9 months)

干预措施: placebo (Other)

Non-steroidal anti-inflammatory drug

Experimental

ibuprofen after exercise training sessions (400 mg, 3 times per week for 9 months)

干预措施: Non-steroidal anti-inflammatory drug (Ibuprofen) (Drug)

Non-steroidal anti-inflammatory drug

Experimental

ibuprofen after exercise training sessions (400 mg, 3 times per week for 9 months)

干预措施: Resistance exercise (Behavioral)

placebo

Placebo Comparator

placebo after exercise training sessions(3 times per week for 9 months)

干预措施: Resistance exercise (Behavioral)

resistance exercise

Experimental

3 sets of 8-12 repetitions of resistance exercises focused on distal radius to be performed 3 times/week for 9 months

干预措施: Non-steroidal anti-inflammatory drug (Ibuprofen) (Drug)

resistance exercise

Experimental

3 sets of 8-12 repetitions of resistance exercises focused on distal radius to be performed 3 times/week for 9 months

干预措施: placebo (Other)

flexibility training

Sham Comparator

flexibility training to be performed 3 days/week for 1 hour for 9 months

干预措施: placebo (Other)

flexibility training

Sham Comparator

flexibility training to be performed 3 days/week for 1 hour for 9 months

干预措施: Flexibility training (Behavioral)

结局指标

主要结局

change from baseline in aBMD of the proximal femur and lumbar spine at 9 months

时间窗: baseline and 9 months

areal bone mineral density of the proximal femure and lumbar spine assessed by dual energy x-ray absorptiometry

次要结局

  • change from baseline in radial shaft muscle cross-sectional area at 9 months(baseline and 9 months)
  • change from baseline in femoral neck section modulus at 9 months(baseline and 9 months)
  • change from baseline in distal radius Bone Strength Index at 9 months(baseline and 9 months)
  • change from baseline in muscular strength at 9 months(baseline and 9 months)
  • change from baseline in balance performance at 9 months(baseline and 9 months)
  • change from baseline in radial shaft Stress Strain Index at 9 months(baseline and 9 months)
  • change from baseline in total body lean tissue mass at 9 months(baseline and 9 months)

研究者

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

Phil Chilibeck

Ph.D.

University of Saskatchewan

研究点 (1)

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