Bone StrengthHiphopNCT02007460
The Influence of High Impact Exercise on Musculoskeletal Health in Older Men
A study testing Exercise in people with Bone Strength and Neuromuscular Function, run by Loughborough University at 1 site in United Kingdom.
Trial summary
Osteoporotic fractures are an extremely common and serious public health issue which contribute substantially to pain, impaired mobility and morbidity in the elderly. Declines in bone strength combined with an increase risk of falls (associated with decline in muscular function with age) are the main determinants of… Read more about this study
- Who is it for?
- Ages 65 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Strength, Neuromuscular Function
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Jan 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 65 to 80 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy community dwelling men of white european origin
Who cannot join
- BMI >30 kg/m2
- History of strength training or recently ( previous 12 months) doing moderate physical activity (weight bearing, high impact)
- Recent ( previous 12 months) or current medical or surgical problems likely to affect bone metabolism or provide contraindications to high impact exercise, balance or neuromuscular function
- Any previous or existing lower back or limb problems that could be exacerbated by undertaking high impact exercise
- Any history of diagnosed or symptomatic diseases likely to influence strength, power, bone or habitual activity (including osteomalacia or impaired liver/renal function and locomotor disease, hypertension) that influences bone or muscle or precludes exercise
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
Osteoporotic fractures are an extremely common and serious public health issue which contribute substantially to pain, impaired mobility and morbidity in the elderly. Declines in bone strength combined with an increase risk of falls (associated with decline in muscular function with age) are the main determinants of fracture risk. Exercise that is novel and involves impact loading has the potential to improve bone strength and neuromuscular function (strength, power and balance). It is thus imperative to evaluate potential benefits of exercise in older people. The musculoskeletal responses to exercise may also be influenced by vitamin D status. It is the purpose of this study to consider the influence of a one year unilateral (one limb) high impact exercise programme on musculoskeletal health, specifically bone structure, muscle strength and power in older caucasian men. It is also the purpose of this study to determine whether this differs according to vitamin D status. The findings will reveal whether exercise can improve bone health and/or neuromuscular function, and whether improvements are dependent upon vitamin D status.
- Conditions
- Bone Strength, Neuromuscular Function
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
multidirectional unilateral hopping exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise leg | Experimental | Not described Receives: Behavioral: Exercise |
| Control leg | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in femoral neck bone mineral density
Measured: baseline, 12 months
Secondary outcomes (8)
Change in cortical bone mineral content
Measured: baseline, 12 months
Change in trabecular bone mineral content
Measured: baseline, 12 months
Change in ground reaction force during hopping
Measured: baseline, 6 months, 12 months
Change in electromyography of quadriceps during hopping
Measured: baseline, 6 months
Change in postural sway amplitude (mm)
Measured: baseline, 6 months
Change in leg press strength
Measured: baseline, 6 months
Change in maximal isometric knee extensor strength
Measured: baseline, 6 months
Change in tendon stiffness
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJan 2010
- Primary completionJan 2012
- Study completionJan 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 Bone StrengthStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester, University Hospitals of Derby and Burton NHS Foundation Trust
- Responsible party
- Principal investigator, Katherine Brooke-Wavell, Loughborough University
- Investigators
- Katherine Brooke-Wavell, PhD, Principal investigator, Loughborough UniversityWinston Rennie, MBBS, Principal investigator, University Hospitals Leicester NHS TrustJonathan Folland, PhD, Principal investigator, Loughborough UniversityGreg Summers, MD, Principal investigator, Derby University Hospitals Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007460
- Sponsor's protocol ID
- R10-P1
- Acronym
- Hiphop
- Status last verified
- Dec 2013
- First submitted
- 27 Nov 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Allison SJ, Folland JP, Rennie WJ, Summers GD, Brooke-Wavell K. High impact exercise increased femoral neck bone mineral density in older men: a randomised unilateral intervention. Bone. 2013 Apr;53(2):321-8. doi: 10.1016/j.bone.2012.12.045. Epub 2013 Jan 3.
PubMed 23291565
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of High Impact Exercise on Musculoskeletal Health in Older Men
- ClinicalTrials.gov ID
- NCT02007460
- Acronym / sponsor ID
- Hiphop / R10-P1
- Conditions
- Bone Strength, Neuromuscular Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester, University Hospitals of Derby and Burton NHS Foundation Trust
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Dec 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.
Osteoporotic fractures are an extremely common and serious public health issue which contribute substantially to pain, impaired mobility and morbidity in the elderly. Declines in bone strength combined with an increase risk of falls (associated with decline in muscular function with age) are the main determinants of fracture risk. Exercise that is novel and involves impact loading has the potential to improve bone strength and neuromuscular function (strength, power and balance). It is thus imperative to evaluate potential benefits of exercise in older people. The musculoskeletal responses to exercise may also be influenced by vitamin D status. It is the purpose of this study to consider the influence of a one year unilateral (one limb) high impact exercise programme on musculoskeletal health, specifically bone structure, muscle strength and power in older caucasian men. It is also the purpose of this study to determine whether this differs according to vitamin D status. The findings will reveal whether exercise can improve bone health and/or neuromuscular function, and whether improvements are dependent upon vitamin D status.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise leg | Experimental | Behavioral: Exercise |
| Control leg | No intervention | – |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Healthy community dwelling men of white european origin
Key exclusion criteria (5 listed)
- BMI >30 kg/m2
- History of strength training or recently ( previous 12 months) doing moderate physical activity (weight bearing, high impact)
- Recent ( previous 12 months) or current medical or surgical problems likely to affect bone metabolism or provide contraindications to high impact exercise, balance or neuromuscular function
- Any previous or existing lower back or limb problems that could be exacerbated by undertaking high impact exercise
- Any history of diagnosed or symptomatic diseases likely to influence strength, power, bone or habitual activity (including osteomalacia or impaired liver/renal function and locomotor disease, hypertension) that influences bone or muscle or precludes exercise
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 |
|---|---|---|
| Exercisemultidirectional unilateral hopping exercise | Behavioural | Exercise leg |
Primary outcome
Change in femoral neck bone mineral density
Time frame: baseline, 12 months
8 secondary outcomes
Change in cortical bone mineral content
Time frame: baseline, 12 months
Change in trabecular bone mineral content
Time frame: baseline, 12 months
Change in ground reaction force during hopping
Time frame: baseline, 6 months, 12 months
Change in electromyography of quadriceps during hopping
Time frame: baseline, 6 months
Change in postural sway amplitude (mm)
Time frame: baseline, 6 months
Change in leg press strength
Time frame: baseline, 6 months
Change in maximal isometric knee extensor strength
Time frame: baseline, 6 months
Change in tendon stiffness
Time frame: baseline, 6 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 10 Dec 2013.
- Results publication: PubMed 23291565Allison SJ, Folland JP, Rennie WJ, Summers GD, Brooke-Wavell K. High impact exercise increased femoral neck bone mineral density in older men: a randomised unilateral intervention. Bone. 2013 Apr;53(2):321-8. doi: 10.1016/j.bone.2012.12.045. Epub 2013 Jan 3.
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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.
Katherine Brooke-Wavell, PhD principal investigator
Loughborough University
Winston Rennie, MBBS principal investigator
University Hospitals Leicester NHS Trust
Jonathan Folland, PhD principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Bone Strength and Neuromuscular Function, run by Loughborough University at 1 site in United Kingdom.
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 5 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 10 Dec 2013. 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 United Kingdom. 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?
Change in femoral neck bone mineral density (time frame: baseline, 12 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 NCT02007460, 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 10 Dec 2013.