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

NCT01886196 | Completed DMC

• 2 other identifiers: 12-256DC0190GP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Sarcopenia; Osteoporosis

Keywords

elderly; women; exercise; pQCT; ibuprofen

Outcome Measures

Primary Outcomes (1)

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

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

  baseline and 9 months

Secondary Outcomes (7)

• 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 radial shaft Stress Strain Index at 9 months

  baseline and 9 months

• change from baseline in radial shaft muscle cross-sectional area at 9 months

  baseline and 9 months

• change from baseline in total body lean tissue mass at 9 months

  baseline and 9 months

Other Outcomes (1)

• 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

  continuously throughout 9 months

Study Arms (4)

Non-steroidal anti-inflammatory drug

EXPERIMENTAL

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

Drug: Non-steroidal anti-inflammatory drug (Ibuprofen); Behavioral: Resistance exercise

placebo

PLACEBO COMPARATOR

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

Other: placebo; Behavioral: Resistance exercise

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

Drug: Non-steroidal anti-inflammatory drug (Ibuprofen); Other: placebo

flexibility training

SHAM COMPARATOR

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

Other: placebo; Behavioral: Flexibility training

Interventions

Non-steroidal anti-inflammatory drug (Ibuprofen) DRUG

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

Also known as: Ibuprofen

Non-steroidal anti-inflammatory drug; resistance exercise

placebo OTHER

placebo designed to mimic experimental drug (ibuprofen)

flexibility training; placebo; resistance exercise

Resistance exercise 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

Non-steroidal anti-inflammatory drug; placebo

Flexibility training BEHAVIORAL

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

flexibility training

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• women \>65yrs

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

College of Kinesiology

Saskatoon, Saskatchewan, S7N5B2, Canada

Location

Related Publications (1)

• 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.

  PMID: 18461099 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Osteoporosis; Motor Activity

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Ibuprofen; Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Philip D Chilibeck, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 25, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)