- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02007460
The Influence of High Impact Exercise on Musculoskeletal Health in Older Men (Hiphop)
December 5, 2013 updated by: Katherine Brooke-Wavell, Loughborough University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Leicestershire
-
Loughborough, Leicestershire, United Kingdom, LE11 3TU
- Loughborough University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy community dwelling men of white european origin
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Exercise leg
|
multidirectional unilateral hopping exercise
|
|
NO_INTERVENTION: Control leg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in femoral neck bone mineral density
Time Frame: baseline, 12 months
|
baseline, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in cortical bone mineral content
Time Frame: baseline, 12 months
|
baseline, 12 months
|
|
Change in trabecular bone mineral content
Time Frame: baseline, 12 months
|
baseline, 12 months
|
|
Change in ground reaction force during hopping
Time Frame: baseline, 6 months, 12 months
|
baseline, 6 months, 12 months
|
|
Change in electromyography of quadriceps during hopping
Time Frame: baseline, 6 months
|
baseline, 6 months
|
|
Change in postural sway amplitude (mm)
Time Frame: baseline, 6 months
|
baseline, 6 months
|
|
Change in leg press strength
Time Frame: baseline, 6 months
|
baseline, 6 months
|
|
Change in maximal isometric knee extensor strength
Time Frame: baseline, 6 months
|
baseline, 6 months
|
|
Change in tendon stiffness
Time Frame: baseline, 6 months
|
baseline, 6 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum 25 hydroxy vitamin D
Time Frame: baseline
|
baseline
|
|
Change in body fat content
Time Frame: baseline, 12 months
|
baseline, 12 months
|
|
change in energy intake (MJ/d)
Time Frame: baseline, 12 months
|
baseline, 12 months
|
|
change in calcium intake
Time Frame: baseline, 12 months
|
baseline, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine Brooke-Wavell, PhD, Loughborough University
- Principal Investigator: Winston Rennie, MBBS, University Hospitals Leicester NHS Trust
- Principal Investigator: Jonathan Folland, PhD, Loughborough University
- Principal Investigator: Greg Summers, MD, Derby University Hospitals Trust
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ACTUAL)
January 1, 2012
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
November 27, 2013
First Submitted That Met QC Criteria
December 5, 2013
First Posted (ESTIMATE)
December 10, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
December 10, 2013
Last Update Submitted That Met QC Criteria
December 5, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- R10-P1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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