Clinical trial NCT02007460: The Influence of High Impact Exercise on Musculoskeletal Health in Older Men
Official title: The Influence of High Impact Exercise on Musculoskeletal Health in Older Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Strength
Neuromuscular Function
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: University Hospitals Leicester NHS Trust, UK
name: University Hospitals of Derby and Burton NHS Foundation Trust
First posted: 2013-12-10
Enrollment: 50
Sex: MALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in femoral neck bone mineral density
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Change in cortical bone mineral content
timeFrame: baseline, 12 months
measure: Change in trabecular bone mineral content
timeFrame: baseline, 12 months
measure: Change in ground reaction force during hopping
timeFrame: baseline, 6 months, 12 months
measure: Change in electromyography of quadriceps during hopping
timeFrame: baseline, 6 months
measure: Change in postural sway amplitude (mm)
timeFrame: baseline, 6 months
measure: Change in leg press strength
timeFrame: baseline, 6 months
measure: Change in maximal isometric knee extensor strength
timeFrame: baseline, 6 months
measure: Change in tendon stiffness
timeFrame: baseline, 6 months
Other outcomes:
measure: Serum 25 hydroxy vitamin D
timeFrame: baseline
measure: Change in body fat content
timeFrame: baseline, 12 months
measure: change in energy intake (MJ/d)
timeFrame: baseline, 12 months
measure: change in calcium intake
timeFrame: baseline, 12 months
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
affiliation: Loughborough University
name: Katherine Brooke-Wavell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Leicester NHS Trust
name: Winston Rennie, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Loughborough University
name: Jonathan Folland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Derby University Hospitals Trust
name: Greg Summers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.