OsteoporosisNCT01482130
High Intensity Strength Training & Bone Mineral Density in Young Women
A study testing Heavy, explosive strength training and recommendations in people with Osteoporosis, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The current guidelines emphasize the prevention of bone loss, by building up bone mass in young age, as one of the most important measures to reduce the incidence of osteoporosis. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Heavy, explosive strength training and recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2011to Jun 2012
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants include young and healthy women between the ages of 18-30, who have not engaged in strength training for the last 6 months.
Who cannot join
- Subjects will be excluded from the study if they have any condition that preclude them from taking part in the exercise testing procedures or the 24 week exercise program or if they fail to obtain the required amount of training sessions.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology
Trondheim, Sor.tronderlag, 7030
About this study
Official title: Preventing Osteoporosis: The Effect of High Intensity Strength Training on Bone Mineral Density in Young and Healthy Women
The current guidelines emphasize the prevention of bone loss, by building up bone mass in young age, as one of the most important measures to reduce the incidence of osteoporosis. Strength training and "explosive" exercises have been shown to have beneficial effects on bone mass and bone metabolism in both young and postmenopausal women. However, meta-analysis concludes that it is still unclear what type of exercises, intensity and execution that is most effective for skeletal adaptations. The following study will examine the effect of 12 weeks of heavy, explosive strength training on bone mineral density and bone metabolism in young, healthy girls aged 18-30 years.
Read the detailed description
Background:
Osteoporosis is a progressive, systemic skeletal disorder characterized by low bone mineral density (BMD), and deterioration of the microarchitecture of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Typically the disease shows no symptoms until a fracture occurs, hence referred to as the "silent epidemic". In Norway one of two women and one of four men experience a fragility fracture after the age of 50. The loss of bone strength with age likely reflects the skeletal response to hormonal changes and the mechanical environment with decreased physical activity. Osteoporotic fractures often happen as a consequence of minimal injury, especially at the hip, spine and wrist. Hip fracture is associated with excess mortality during the first year after fracture ranging from 8.4% to 36%. The increased mortality risk may persist for several years thereafter, highlighting the need for interventions to reduce this risk. Osteoporosis is a common disease and recognized as a global problem by the WHO.
The American College of Sport Medicine suggests exercise as a countermeasure against bone loss in postmenopausal woman and elderly subjects. Peak bone mass is thought to be attained by the end of the third decade, hence the early adult years might be the final opportunity for its augmentation. It is indicated that optimizing peak bone mass may have long-term effect on bone health. Intervention studies with young women show that high impact exercises may improve BMD in young adults. High intensity strength training also seems to effectively improve BMD and the ratio of bone turnover markers. Furthermore, an explosive execution of movement may be important for obtaining BMD improvements from resistance training. Maximal strength training (MST) is characterized by high mobilization of force, high loads, and few repetitions (3-5 reps.) per set with emphasis on maximal force mobilization in the concentric part of the movement. Recent studies have shown that MST is highly efficient for improving maximal strength (1RM) and rate of force development (RFD). Parameters such as 1RM and RFD are closely related to BMD. In addition, a recent study from our group showed that 12 weeks of MST training (three times each week) improved bone mass in the hip and spine of postmenopausal women, diagnosed with osteoporosis (article in preparation). In the present study we want to investigate the impact of heavy, explosive strength training on bone mass and bone metabolism in young and healthy woman which have not yet reached peak bone mass.
Physical activity and BMD:
One of the main factors responsible for the high incidence of osteoporosis is physical inactivity. Several studies have shown that physical activity can lead to an increase in BMD. Resistance- and impact exercises have shown to be most effective. A number of studies performed with sedentary young women performing high impact training has shown significant improvement in BMD at the femoral neck and lumbar spine. A study with postmenopausal women showed that power training is more effective in maintaining BMD in the lumbar spine and total hip than conventional strength training.
The effect of training at the cellular and tissue level can be divided into 3 main factors:
- Increased osteoblast activity and bone formation
- Reduced osteoclast activity and bone resorption
- Increased stability of the bone's architectural structure
In terms of prevention of osteoporosis the current exercise guidelines, according to the WHO, is encouragement of a physically active lifestyle. Weight bearing activities, preferably resistance training are recommended for patients with osteoporosis. Peak bone mass is an important factor in determining long-term fracture risk. Therefore, effective strategies to maximize peak bone mass in young adults are essential. Evidence indicates that resistance and high-impact exercise are the most beneficial to maintain and optimize peak bone mass in young adults. However, studies investigating such exercises are not altogether conclusive, and the mode of exercise, regarding type of exercise, intensity and execution, still remains unclear. Since MST exercise may increase bone mass in osteoporotic women, and improves 1RM and RFD (which are closely related to skeletal health) we wish to investigate the potential of MST training to increase bone mass and improve bone metabolism in young female adults, who have not yet reached peak bone mass.
Goals of the study:
- Investigate the effect of heavy, explosive strength training on bone mineral density compared to a control group in young, healthy women over a period of 3 months.
- Study the effect of this training intervention on bone formation and resorption markers
- Study the effect on physical capacity measurements.
- Conditions
- Osteoporosis
- Being tested
- Heavy, explosive strength training, recommendations
- Keywords
- Exercise, osteoporosis, prevention
- Medical subject headings
- Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heavy, explosive strength trainingBehavioural
All participants of the training group will pursue a 12 weeks of heavy, explosive strength training, 3 sessions a week for a total of 36 sessions. The training session will include one squat exercise only, which allows muscle contraction of the quadriceps from a 90° bend at the knees to straight legs.
recommendationsBehavioural
The control group will be encouraged to follow a training program according to recommended exercise guidelines:
- Weight bearing activities (walking, jogging or strength training)
- 30 - 60 minutes, 3 - 5 times each week
- A total of 2 - 3 hours each week should be achieved
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | All participants in the training group will pursue a 12 weeks of strength training. Receives: Behavioral: Heavy, explosive strength training |
| Controls | Other | The control group will be encouraged to follow a training program according to recommended exercise guidelines Receives: Behavioral: recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
(Dual X-ray Absorptiometry)
Measured: Baseline and 12 weeks
Secondary outcomes (4)
Serum markers of bone metabolism
Blood samples will be drawn for analyses of bone metabolism and markers of bone formation; osteoprotegerin (OPG) and Type I procollagen N-terminal propeptide (PINP). Furthermore, Type 1 collagen C-breakdown products (CTX) and receptor activator of NF kappa B ligand (RANKL) which are the key regulators of bone resorption, will be analyzed at the start and end of the study.
Measured: Baseline and 12 weeks
Body composition
Lean- versus fat mass, measured by Dual X-ray Absorptiometry (DXA).
Measured: Baseline and 12 weeks
Maximal muscle strength
Measured as one repetition maximum in a squat exercise machine.
Measured: Baseline and 12 weeks
Rate of force development
Maesured dynamic in a squat exercise maschine, and isometric at 90 degree angle in the knee joint.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionJun 2012
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 OsteoporosisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Unni Syversen, MD, PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482130
- Sponsor's protocol ID
- REK-2011/2039
- Status last verified
- Jul 2016
- First submitted
- 16 Nov 2011
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mosti MP, Carlsen T, Aas E, Hoff J, Stunes AK, Syversen U. Maximal strength training improves bone mineral density and neuromuscular performance in young adult women. J Strength Cond Res. 2014 Oct;28(10):2935-45. doi: 10.1519/JSC.0000000000000493.
PubMed 24736773
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Osteoporosis: The Effect of High Intensity Strength Training on Bone Mineral Density in Young and Healthy Women
- ClinicalTrials.gov ID
- NCT01482130
- Acronym / sponsor ID
- REK-2011/2039
- Conditions
- Osteoporosis
- Keywords
- Exercise, osteoporosis, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Nov 2011 (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.
The current guidelines emphasize the prevention of bone loss, by building up bone mass in young age, as one of the most important measures to reduce the incidence of osteoporosis. Strength training and "explosive" exercises have been shown to have beneficial effects on bone mass and bone metabolism in both young and postmenopausal women. However, meta-analysis concludes that it is still unclear what type of exercises, intensity and execution that is most effective for skeletal adaptations. The following study will examine the effect of 12 weeks of heavy, explosive strength training on bone mineral density and bone metabolism in young, healthy girls aged 18-30 years.
Detailed description
Background:
Osteoporosis is a progressive, systemic skeletal disorder characterized by low bone mineral density (BMD), and deterioration of the microarchitecture of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Typically the disease shows no symptoms until a fracture occurs, hence referred to as the "silent epidemic". In Norway one of two women and one of four men experience a fragility fracture after the age of 50. The loss of bone strength with age likely reflects the skeletal response to hormonal changes and the mechanical environment with decreased physical activity. Osteoporotic fractures often happen as a consequence of minimal injury, especially at the hip, spine and wrist. Hip fracture is associated with excess mortality during the first year after fracture ranging from 8.4% to 36%. The increased mortality risk may persist for several years thereafter, highlighting the need for interventions to reduce this risk. Osteoporosis is a common disease and recognized as a global problem by the WHO.
The American College of Sport Medicine suggests exercise as a countermeasure against bone loss in postmenopausal woman and elderly subjects. Peak bone mass is thought to be attained by the end of the third decade, hence the early adult years might be the final opportunity for its augmentation. It is indicated that optimizing peak bone mass may have long-term effect on bone health. Intervention studies with young women show that high impact exercises may improve BMD in young adults. High intensity strength training also seems to effectively improve BMD and the ratio of bone turnover markers. Furthermore, an explosive execution of movement may be important for obtaining BMD improvements from resistance training. Maximal strength training (MST) is characterized by high mobilization of force, high loads, and few repetitions (3-5 reps.) per set with emphasis on maximal force mobilization in the concentric part of the movement. Recent studies have shown that MST is highly efficient for improving maximal strength (1RM) and rate of force development (RFD). Parameters such as 1RM and RFD are closely related to BMD. In addition, a recent study from our group showed that 12 weeks of MST training (three times each week) improved bone mass in the hip and spine of postmenopausal women, diagnosed with osteoporosis (article in preparation). In the present study we want to investigate the impact of heavy, explosive strength training on bone mass and bone metabolism in young and healthy woman which have not yet reached peak bone mass.
Physical activity and BMD:
One of the main factors responsible for the high incidence of osteoporosis is physical inactivity. Several studies have shown that physical activity can lead to an increase in BMD. Resistance- and impact exercises have shown to be most effective. A number of studies performed with sedentary young women performing high impact training has shown significant improvement in BMD at the femoral neck and lumbar spine. A study with postmenopausal women showed that power training is more effective in maintaining BMD in the lumbar spine and total hip than conventional strength training.
The effect of training at the cellular and tissue level can be divided into 3 main factors:
- Increased osteoblast activity and bone formation
- Reduced osteoclast activity and bone resorption
- Increased stability of the bone's architectural structure
In terms of prevention of osteoporosis the current exercise guidelines, according to the WHO, is encouragement of a physically active lifestyle. Weight bearing activities, preferably resistance training are recommended for patients with osteoporosis. Peak bone mass is an important factor in determining long-term fracture risk. Therefore, effective strategies to maximize peak bone mass in young adults are essential. Evidence indicates that resistance and high-impact exercise are the most beneficial to maintain and optimize peak bone mass in young adults. However, studies investigating such exercises are not altogether conclusive, and the mode of exercise, regarding type of exercise, intensity and execution, still remains unclear. Since MST exercise may increase bone mass in osteoporotic women, and improves 1RM and RFD (which are closely related to skeletal health) we wish to investigate the potential of MST training to increase bone mass and improve bone metabolism in young female adults, who have not yet reached peak bone mass.
Goals of the study:
- Investigate the effect of heavy, explosive strength training on bone mineral density compared to a control group in young, healthy women over a period of 3 months.
- Study the effect of this training intervention on bone formation and resorption markers
- Study the effect on physical capacity measurements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Behavioral: Heavy, explosive strength trainingAll participants in the training group will pursue a 12 weeks of strength training. |
| Controls | Other | Behavioral: recommendationsThe control group will be encouraged to follow a training program according to recommended exercise guidelines |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants include young and healthy women between the ages of 18-30, who have not engaged in strength training for the last 6 months.
Key exclusion criteria (1 listed)
- Subjects will be excluded from the study if they have any condition that preclude them from taking part in the exercise testing procedures or the 24 week exercise program or if they fail to obtain the required amount of training sessions.
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 |
|---|---|---|
| Heavy, explosive strength trainingAll participants of the training group will pursue a 12 weeks of heavy, explosive strength training, 3 sessions a week for a total of 36 sessions. The training session will include one squat exercise only, which allows muscle contraction of the quadriceps from a 90° bend at the knees to straight legs. | Behavioural | Training group |
| recommendationsThe control group will be encouraged to follow a training program according to recommended exercise guidelines: * Weight bearing activities (walking, jogging or strength training) * 30 - 60 minutes, 3 - 5 times each week * A total of 2 - 3 hours each week should be achieved | Behavioural | Controls |
Primary outcome
Bone mineral density
Time frame: Baseline and 12 weeks
(Dual X-ray Absorptiometry)
4 secondary outcomes
Serum markers of bone metabolism
Time frame: Baseline and 12 weeks
Body composition
Time frame: Baseline and 12 weeks
Maximal muscle strength
Time frame: Baseline and 12 weeks
Rate of force development
Time frame: Baseline and 12 weeks
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 1 Aug 2016.
- Results publication: PubMed 24736773Mosti MP, Carlsen T, Aas E, Hoff J, Stunes AK, Syversen U. Maximal strength training improves bone mineral density and neuromuscular performance in young adult women. J Strength Cond Res. 2014 Oct;28(10):2935-45. doi: 10.1519/JSC.0000000000000493.
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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.
Unni Syversen, MD, PhD study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heavy, explosive strength training and recommendations in people with Osteoporosis, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 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 1 Aug 2016. 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 Norway. 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. 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?
Bone mineral density (time frame: Baseline and 12 weeks). 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 NCT01482130, 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 1 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.