SarcopeniaNCT01886196
Ibuprofen Supplementation After Resistance Training and Its Effects on Bone in Older Women
A study testing Non-steroidal anti-inflammatory drug (Ibuprofen), Resistance exercise and Flexibility training in people with Sarcopenia and Osteoporosis, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Osteoporosis
- What is being tested?
- Non-steroidal anti-inflammatory drug (Ibuprofen), Resistance exercise and Flexibility training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- women >65yrs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Non-steroidal anti-inflammatory drug (Ibuprofen), placebo, Resistance exercise, Flexibility training
- Keywords
- elderly, women, exercise, pQCT, ibuprofen
- Medical subject headings
- Sarcopenia, Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-steroidal anti-inflammatory drug (Ibuprofen)Drug
Also called Ibuprofen
400mg of ibuprofen administered after exercise training session 3 days per week
placeboOther
placebo designed to mimic experimental drug (ibuprofen)
Resistance exerciseBehavioural
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
Flexibility trainingBehavioural
3 days of full body stretching program (approximately 1 hour) to be performed at participants home unsupervised
| Study group | Role | What they receive |
|---|---|---|
| Non-steroidal anti-inflammatory drug | Experimental | ibuprofen after exercise training sessions (400 mg, 3 times per week for 9 months) Receives: 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) Receives: 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 Receives: 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 Receives: Other: placebo; Behavioral: Flexibility training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 9 months
Secondary outcomes (7)
change from baseline in femoral neck section modulus at 9 months
femoral neck section modulus assessed by dual energy x-ray absorptiometry
Measured: baseline and 9 months
change from baseline in distal radius Bone Strength Index at 9 months
distal radius Bone Strength Index assessed by high resolution peripheral quantitative computed tomography
Measured: baseline and 9 months
change from baseline in radial shaft Stress Strain Index at 9 months
radial shaft Stress Strain Index assessed by peripheral quantitative computed tomography
Measured: baseline and 9 months
change from baseline in radial shaft muscle cross-sectional area at 9 months
radial shaft muscle cross-sectional area assessed by peripheral quantitative computed tomography
Measured: baseline and 9 months
change from baseline in total body lean tissue mass at 9 months
total body lean tissue mass assessed by dual energy x-ray absorptiometry
Measured: baseline and 9 months
change from baseline in muscular strength at 9 months
muscular strength assessed by 1 repetition maximum bicep curl and leg press
Measured: baseline and 9 months
change from baseline in balance performance at 9 months
balance performance assessed by tandem walk on balance board
Measured: baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Phil Chilibeck, University of Saskatchewan
- Investigators
- Philip D Chilibeck, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886196
- Sponsor's protocol ID
- 12-256
- Other IDs
- DC0190GP
- Status last verified
- May 2017
- First submitted
- 20 Jun 2013
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 18461099
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen Supplementation After Resistance Training and Its Effects on Bone in Older Women
- ClinicalTrials.gov ID
- NCT01886196
- Acronym / sponsor ID
- 12-256
- Conditions
- Sarcopenia, Osteoporosis
- Keywords
- elderly, women, exercise, pQCT, ibuprofen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-steroidal anti-inflammatory drug | Experimental | Drug: Non-steroidal anti-inflammatory drug (Ibuprofen), Behavioral: Resistance exerciseibuprofen after exercise training sessions (400 mg, 3 times per week for 9 months) |
| placebo | Placebo comparator | Other: placebo, Behavioral: Resistance exerciseplacebo after exercise training sessions(3 times per week for 9 months) |
| resistance exercise | Experimental | Drug: Non-steroidal anti-inflammatory drug (Ibuprofen), Other: placebo3 sets of 8-12 repetitions of resistance exercises focused on distal radius to be performed 3 times/week for 9 months |
| flexibility training | Sham comparator | Other: placebo, Behavioral: Flexibility trainingflexibility training to be performed 3 days/week for 1 hour for 9 months |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- women >65yrs
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-steroidal anti-inflammatory drug (Ibuprofen)Also: Ibuprofen400mg of ibuprofen administered after exercise training session 3 days per week | Drug | Non-steroidal anti-inflammatory drug, resistance exercise |
| placeboplacebo designed to mimic experimental drug (ibuprofen) | Other | flexibility training, placebo, resistance exercise |
| Resistance exercise3 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 | Behavioural | Non-steroidal anti-inflammatory drug, placebo |
| Flexibility training3 days of full body stretching program (approximately 1 hour) to be performed at participants home unsupervised | Behavioural | flexibility training |
Primary outcome
change from baseline in aBMD of the proximal femur and lumbar spine at 9 months
Time frame: baseline and 9 months
areal bone mineral density of the proximal femure and lumbar spine assessed by dual energy x-ray absorptiometry
7 secondary outcomes
change from baseline in femoral neck section modulus at 9 months
Time frame: baseline and 9 months
change from baseline in distal radius Bone Strength Index at 9 months
Time frame: baseline and 9 months
change from baseline in radial shaft Stress Strain Index at 9 months
Time frame: baseline and 9 months
change from baseline in radial shaft muscle cross-sectional area at 9 months
Time frame: baseline and 9 months
change from baseline in total body lean tissue mass at 9 months
Time frame: baseline and 9 months
change from baseline in muscular strength at 9 months
Time frame: baseline and 9 months
change from baseline in balance performance at 9 months
Time frame: baseline and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Background: PubMed 18461099Krentz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip D Chilibeck, PhD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-steroidal anti-inflammatory drug (Ibuprofen), Resistance exercise and Flexibility training in people with Sarcopenia and Osteoporosis, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in aBMD of the proximal femur and lumbar spine at 9 months (time frame: baseline and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01886196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.