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

NCT ID: NCT01886196

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-07-31

Brief 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

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.

Conditions

Sarcopenia; Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Non-steroidal anti-inflammatory drug

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

Group Type: EXPERIMENTAL

Non-steroidal anti-inflammatory drug (Ibuprofen)

Intervention Type: DRUG

400mg of ibuprofen administered after exercise training session 3 days per week

Resistance exercise

Intervention Type: BEHAVIORAL

3 sets of 8-12 repetitions of resistance exercise (full body with a focus on the distal radius) completed 3 days/week under supervision in the research gym

placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo designed to mimic experimental drug (ibuprofen)

Resistance exercise

Intervention Type: BEHAVIORAL

3 sets of 8-12 repetitions of resistance exercise (full body with a focus on the distal radius) completed 3 days/week under supervision in the research gym

resistance exercise

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

Group Type: EXPERIMENTAL

Non-steroidal anti-inflammatory drug (Ibuprofen)

Intervention Type: DRUG

400mg of ibuprofen administered after exercise training session 3 days per week

placebo

Intervention Type: OTHER

placebo designed to mimic experimental drug (ibuprofen)

flexibility training

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

Group Type: SHAM_COMPARATOR

placebo

Intervention Type: OTHER

placebo designed to mimic experimental drug (ibuprofen)

Flexibility training

Intervention Type: BEHAVIORAL

3 days of full body stretching program (approximately 1 hour) to be performed at participants home unsupervised

Interventions

Non-steroidal anti-inflammatory drug (Ibuprofen)

400mg of ibuprofen administered after exercise training session 3 days per week

Intervention Type: DRUG

placebo

placebo designed to mimic experimental drug (ibuprofen)

Intervention Type: OTHER

Resistance exercise

3 sets of 8-12 repetitions of resistance exercise (full body with a focus on the distal radius) completed 3 days/week under supervision in the research gym

Intervention Type: BEHAVIORAL

Flexibility training

3 days of full body stretching program (approximately 1 hour) to be performed at participants home unsupervised

Intervention Type: BEHAVIORAL

Other Intervention Names

Ibuprofen

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Phil Chilibeck

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip D Chilibeck, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

College of Kinesiology

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 18461099 (View on PubMed)

Other Identifiers

DC0190GP

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

12-256

Identifier Type: -

Identifier Source: org_study_id