Ibuprofen Supplementation After Resistance Training and Its Effects on Bone in Older Women
Information source: University of Saskatchewan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sarcopenia; Osteoporosis
Intervention: Non-steroidal anti-inflammatory drug (Ibuprofen) (Drug); placebo (Other); Resistance exercise (Behavioral); Flexibility training (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: University of Saskatchewan Official(s) and/or principal investigator(s): Philip D Chilibeck, PhD, Principal Investigator, Affiliation: University of Saskatchewan
Summary
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
Clinical Details
Official title: Ibuprofen Supplementation After Resistance Training and Its Effects on Bone in Older Women
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: change from baseline in aBMD of the proximal femur and lumbar spine at 9 months
Secondary outcome: change from baseline in femoral neck section modulus at 9 monthschange from baseline in distal radius Bone Strength Index at 9 months change from baseline in radial shaft Stress Strain Index at 9 months change from baseline in radial shaft muscle cross-sectional area at 9 months change from baseline in total body lean tissue mass at 9 months change from baseline in muscular strength at 9 months change from baseline in balance performance at 9 months
Detailed description:
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.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- women >65yrs
Exclusion Criteria:
- 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
Locations and Contacts
College of Kinesiology, Saskatoon, Saskatchewan S7N5B2, Canada
Additional Information
Related publications: Krentz JR, Quest B, Farthing JP, Quest DW, Chilibeck PD. The effects of ibuprofen on muscle hypertrophy, strength, and soreness during resistance training. Appl Physiol Nutr Metab. 2008 Jun;33(3):470-5. doi: 10.1139/H08-019.
Starting date: April 2013
Last updated: December 1, 2014
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