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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Saskatchewan
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01886196
First received: June 20, 2013
Last updated: June 24, 2013
Last verified: March 2013
  Purpose

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

Condition Intervention
Sarcopenia
Osteoporosis
Drug: Non-steroidal anti-inflammatory drug (Ibuprofen)
Other: placebo
Behavioral: Resistance exercise
Behavioral: Flexibility training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ibuprofen Supplementation After Resistance Training and Its Effects on Bone in Older Women

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • change from baseline in aBMD of the proximal femur and lumbar spine at 9 months [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    areal bone mineral density of the proximal femure and lumbar spine assessed by dual energy x-ray absorptiometry


Secondary Outcome Measures:
  • change from baseline in femoral neck section modulus at 9 months [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    femoral neck section modulus assessed by dual energy x-ray absorptiometry

  • change from baseline in distal radius Bone Strength Index at 9 months [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    distal radius Bone Strength Index assessed by high resolution peripheral quantitative computed tomography

  • change from baseline in radial shaft Stress Strain Index at 9 months [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    radial shaft Stress Strain Index assessed by peripheral quantitative computed tomography

  • change from baseline in radial shaft muscle cross-sectional area at 9 months [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    radial shaft muscle cross-sectional area assessed by peripheral quantitative computed tomography

  • change from baseline in total body lean tissue mass at 9 months [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    total body lean tissue mass assessed by dual energy x-ray absorptiometry

  • change from baseline in muscular strength at 9 months [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    muscular strength assessed by 1 repetition maximum bicep curl and leg press

  • change from baseline in balance performance at 9 months [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
    balance performance assessed by tandem walk on balance board


Other Outcome Measures:
  • number of participants with adverse events as a measure of safety and number of participants wit adverse events as a measure of safety and tolerability [ Time Frame: continuously throughout 9 months ] [ Designated as safety issue: Yes ]
    adverse events as reported by participants and charted on 'adverse events' form


Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-steroidal anti-inflammatory drug
ibuprofen after exercise training sessions (400 mg, 3 times per week for 9 months)
Drug: Non-steroidal anti-inflammatory drug (Ibuprofen)
400mg of ibuprofen administered after exercise training session 3 days per week
Other Name: Ibuprofen
Behavioral: 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
Placebo Comparator: placebo
placebo after exercise training sessions(3 times per week for 9 months)
Other: placebo
placebo designed to mimic experimental drug (ibuprofen)
Behavioral: 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
Experimental: resistance exercise
3 sets of 8-12 repetitions of resistance exercises focused on distal radius to be performed 3 times/week for 9 months
Drug: Non-steroidal anti-inflammatory drug (Ibuprofen)
400mg of ibuprofen administered after exercise training session 3 days per week
Other Name: Ibuprofen
Other: placebo
placebo designed to mimic experimental drug (ibuprofen)
Sham Comparator: flexibility training
flexibility training to be performed 3 days/week for 1 hour for 9 months
Other: placebo
placebo designed to mimic experimental drug (ibuprofen)
Behavioral: Flexibility training
3 days of full body stretching program (approximately 1 hour) to be performed at participants home unsupervised

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886196

Contacts
Contact: Philip D Chilibeck, PhD 306-966-1072 phil.chilibeck@usask.ca
Contact: Saija A Kontulainen, PhD 306.966.1077 saija.kontulainen@usask.ca

Locations
Canada, Saskatchewan
College of Kinesiology Recruiting
Saskatoon, Saskatchewan, Canada, S7N5B2
Contact: Julianne Rooke, B.Sc.    306-966-1186    julianne.rooke@usask.ca   
Contact: Whitney Duff, M.Sc.    306-966-1186    whitney.duff@usask.ca   
Principal Investigator: Philip Chilibeck, Ph.D.         
Sponsors and Collaborators
University of Saskatchewan
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Philip D Chilibeck, PhD University of Saskatchewan
  More Information

Publications:
Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01886196     History of Changes
Other Study ID Numbers: 12-256, DC0190GP
Study First Received: June 20, 2013
Last Updated: June 24, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Saskatchewan:
elderly
women
exercise
pQCT
ibuprofen

Additional relevant MeSH terms:
Osteoporosis
Sarcopenia
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Anti-Inflammatory Agents
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014