NCT02007460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

November 27, 2013

Last Update Submit

December 5, 2013

Conditions

Bone StrengthNeuromuscular Function

Outcome Measures

Primary Outcomes (1)

  • Change in femoral neck bone mineral density

    baseline, 12 months

Secondary Outcomes (8)

  • Change in cortical bone mineral content

    baseline, 12 months

  • Change in trabecular bone mineral content

    baseline, 12 months

  • Change in ground reaction force during hopping

    baseline, 6 months, 12 months

  • Change in electromyography of quadriceps during hopping

    baseline, 6 months

  • Change in postural sway amplitude (mm)

    baseline, 6 months

  • +3 more secondary outcomes

Other Outcomes (4)

  • Serum 25 hydroxy vitamin D

    baseline

  • Change in body fat content

    baseline, 12 months

  • change in energy intake (MJ/d)

    baseline, 12 months

  • +1 more other outcomes

Study Arms (2)

Exercise leg

EXPERIMENTAL
Behavioral: Exercise

Control leg

NO INTERVENTION

Interventions

ExerciseBEHAVIORAL

multidirectional unilateral hopping exercise

Exercise leg

Eligibility Criteria

Age65 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy community dwelling men of white european origin

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

Related 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 3.

    PMID: 23291565RESULT

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Human Biology

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 10, 2013

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations

GB(1)