Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02007460
Other study ID # R10-P1
Secondary ID
Status Completed
Phase N/A
First received November 27, 2013
Last updated December 5, 2013
Start date January 2010
Est. completion date January 2012

Study information

Verified date December 2013
Source Loughborough University
Contact n/a
Is FDA regulated No
Health authority UK: National Research Ethics ServiceUK: Loughborough University Ethical Advisory Committee
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 65 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
multidirectional unilateral hopping exercise

Locations

Country Name City State
United Kingdom Loughborough University Loughborough Leicestershire

Sponsors (3)

Lead Sponsor Collaborator
Loughborough University Derby Hospitals NHS Foundation Trust, University Hospitals Leicester NHS Trust, UK

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Serum 25 hydroxy vitamin D baseline No
Other Change in body fat content baseline, 12 months No
Other change in energy intake (MJ/d) baseline, 12 months No
Other change in calcium intake baseline, 12 months No
Primary Change in femoral neck bone mineral density baseline, 12 months No
Secondary Change in cortical bone mineral content baseline, 12 months No
Secondary Change in trabecular bone mineral content baseline, 12 months No
Secondary Change in ground reaction force during hopping baseline, 6 months, 12 months No
Secondary Change in electromyography of quadriceps during hopping baseline, 6 months No
Secondary Change in postural sway amplitude (mm) baseline, 6 months No
Secondary Change in leg press strength baseline, 6 months No
Secondary Change in maximal isometric knee extensor strength baseline, 6 months No
Secondary Change in tendon stiffness baseline, 6 months No
See also
  Status Clinical Trial Phase
Completed NCT01848665 - The Influence of Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Passive Heat Stress Phase 4
Completed NCT05219344 - Tissue Flossing and Lower Limb Neuromuscular Function N/A
Suspended NCT04245332 - Effects of Fish Oil and Resistance Training on Muscle Mass and Function N/A
Completed NCT03752060 - The Clinical Utility of Resistance Training for Improving Cardiovascular Disease Risk in Post-Menopausal Women N/A
Completed NCT02015611 - Vitamin D Supplementation and Muscle Function in Older Adults N/A
Completed NCT01830335 - Cerebral Blood Flow and PETCO2 on Neuromuscular Function During Environmental Stress Phase 4