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The Effect of High Impact Exercise on Bone and Articular Cartilage in Post-menopausal Women

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ClinicalTrials.gov Identifier: NCT03225703
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Katherine Brooke-Wavell, Loughborough University

Brief Summary:

Osteoarthritis (OA) and osteoporosis (OP) affect large numbers of the population. Around 8 million people in the UK are affected by OA and over 300,000 people present with fragility fractures in the UK each year. High impact exercise has been shown to improve markers of bone health but the effect of this exercise on the cartilage is less well understood. A six month, one leg, exercise program based on hopping will be carried out by a group of post-menopausal women. Post-menopausal women are particularly at risk from OP and the research should give information on the feasibility of this type of exercise program in this age group and the effect on cartilage. Participants will be aged between 55 and 70 (at least five years post menopause) with no conditions that would limit their ability to complete the exercise program.

To assess changes in participants' cartilage and bone properties they will be asked to attend several meetings at Loughborough University. Before and after the exercise program participants will have bone density scans and MRI scans of the knee joint. A subset (n=4) will undergo high resolution bone scans that can demonstrate changes in bone structure. The intervention is a home based exercise programme lasting approximately 10 minutes per day. Initially this will be individualised to each participant with the end goal being daily exercise sessions. The programme will last for six months with supervised sessions offered throughout the trial. Using an intervention affecting just one leg will allow the research team to use the other leg as a control.

The research team hypothesise that in a population of post-menopausal women, a six month, unilateral exercise intervention will improve bone mineral density at the proximal femur with no negative effects on articular cartilage.


Condition or disease Intervention/treatment Phase
Osteoporosis, Postmenopausal Osteoarthritis, Knee BMD Behavioral: Hopping Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will complete a unilateral exercise intervention and be randomly assigned an exercise leg. This allows for internal control, non exercise leg. The exercise and control leg will be analysed for significant differences following completion of the intervention.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of High Impact Exercise on Bone and Articular Cartilage in Post-menopausal Women
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Exercise Leg
Left or right leg randomly assigned as exercise leg in a unilateral, exercise intervention. This will be a progressive exercise programme with the aim being to complete 50 multidirectional hops completed daily. (Hopping)
Behavioral: Hopping
A unilateral, hopping based exercise programme lasting six months.

No Intervention: Non exercise Leg
Randomly assigned non-exercise, control leg.



Primary Outcome Measures :
  1. Change in T2 Relaxation Time (ms) [ Time Frame: 6 months (pre and post intervention) ]
    T2 mapping is an indicator of the water content in cartilage, with longer relaxation times a marker of cartilage degeneration


Secondary Outcome Measures :
  1. Change in Femoral neck bone mineral density (g/cm2) [ Time Frame: 6 months (pre and post intervention) ]
  2. Change in Femoral neck bone mineral content (g) [ Time Frame: 6 months (pre and post intervention) ]
  3. Change in Spine bone mineral density (g/cm2) [ Time Frame: 6 months (pre and post intervention) ]
  4. Change in Spine bone mineral content (g) [ Time Frame: 6 months (pre and post intervention) ]
  5. Change in Postural sway (mm) [ Time Frame: 6 months (pre and post intervention) ]
  6. Change in Maximal hop height (mm) [ Time Frame: 6 months (pre and post intervention) ]
  7. Change in Ground Reaction force Maximal Hop (N) [ Time Frame: 6 months (pre and post intervention) ]
  8. Change in Ground Reaction force for a set of ten hops (N) [ Time Frame: 6 months (pre and post intervention) ]
  9. Change in BMD(D100) (mg HA/cm3) [ Time Frame: 6 months (pre and post intervention) ]
    Volumetric Bone mineral density

  10. Change in Total bone mass (mg) [ Time Frame: 6 months (pre and post intervention) ]
  11. Change in BV/TV (%) [ Time Frame: 6 months (pre and post intervention) ]
    Percent bone volume

  12. Change in pBV/TV (%) [ Time Frame: 6 months (pre and post intervention) ]
    Plate bone volume fraction

  13. Change in rBV/TV (%) [ Time Frame: 6 months (pre and post intervention) ]
    Rod bone volume fraction

  14. Change in pBV/rBV (%) [ Time Frame: 6 months (pre and post intervention) ]
    Plate to - rod ratio

  15. Change in pBV/BV (%) [ Time Frame: 6 months (pre and post intervention) ]
    Plate tissue fraction

  16. Change in rBV/BV (%) [ Time Frame: 6 months (pre and post intervention) ]
    Rod tissue fraction

  17. Change in Bone surface(BS) (mm2) [ Time Frame: 6 months (pre and post intervention) ]
  18. Change in BS/TV (mm-1) [ Time Frame: 6 months (pre and post intervention) ]
    Bone surface density

  19. Change in Tb.Th (mm) [ Time Frame: 6 months (pre and post intervention) ]
    Trabecular thickness

  20. Change in Tb.Sp (mm) [ Time Frame: 6 months (pre and post intervention) ]
    Trabecular Separation

  21. Change in Tb.N (mm-1) [ Time Frame: 6 months (pre and post intervention) ]
    Trabecular number

  22. Change in Tb.Pf [ Time Frame: 6 months (pre and post intervention) ]
    Trabecular bone pattern (Tb.PF) follows the course of stress lines in the bone. This measurement indicates where the bone is under increased stress.

  23. Change in Conn.D (mm-3) [ Time Frame: 6 months (pre and post intervention) ]
    Connectivity density

  24. Change in DA [ Time Frame: 6 months (pre and post intervention) ]
    Degree of anisotropy

  25. Change in τ [ Time Frame: 6 months (pre and post intervention) ]
    Tortuosity (τ) is a measure of how well a structure can curve and bend easily. This is an indicator of where the most stress is on the bone structure.

  26. Change in SMI [ Time Frame: 6 months (pre and post intervention) ]
    Structural model index

  27. Change in BRV (mm3) [ Time Frame: 6 months (pre and post intervention) ]
    Bone resorption volume

  28. Change in BFV (mm3) [ Time Frame: 6 months (pre and post intervention) ]
    Bone formation volume

  29. Change in BRM (mg) [ Time Frame: 6 months (pre and post intervention) ]
    Bone resorption mass

  30. Change in BFM (mg) [ Time Frame: 6 months (pre and post intervention) ]
    Bone formation mass

  31. Change in BRF (%) [ Time Frame: 6 months (pre and post intervention) ]
    Bone resorption fraction

  32. Change in BFF(%) [ Time Frame: 6 months (pre and post intervention) ]
    Bone formation fraction

  33. Change in BRR(mm3/week) [ Time Frame: 6 months (pre and post intervention) ]
    Bone resorption rate

  34. Change in BFR(mm3/week) [ Time Frame: 6 months (pre and post intervention) ]
    Bone formation rate

  35. Change in Trabecular orientation distribution (Tb.O.D) (angle in degrees) [ Time Frame: 6 months (pre and post intervention) ]
    This is a measurement of the orientation of the trabeculae in the distal tibia relative to the central axis tibial shaft. The orientation can be categorised into transvers direction and longitudinal direction along the tibial shaft

  36. Change in Ct.Th(mm) [ Time Frame: 6 months (pre and post intervention) ]
    Cortical thickness

  37. Change in B.Po(%) [ Time Frame: 6 months (pre and post intervention) ]
    Bone porosity

  38. Change in Po.Dm(mm) [ Time Frame: 6 months (pre and post intervention) ]
    Pore diameter

  39. Change in Pore volume distribution [ Time Frame: 6 months (pre and post intervention) ]
  40. Change in Failure load (N) [ Time Frame: 6 months (pre and post intervention) ]
  41. Change in Strain [ Time Frame: 6 months (pre and post intervention) ]
    This analyses the change in length of the bone over the time period, expressed as % change.

  42. Change in Stiffness (N/mm) [ Time Frame: 6 months (pre and post intervention) ]
  43. Change in Young's Modulus (GPa) [ Time Frame: 6 months (pre and post intervention) ]
  44. Change in Mechanical anisotropic ratio [ Time Frame: 6 months (pre and post intervention) ]
  45. Change in Strain energy density (J/m3) [ Time Frame: 6 months (pre and post intervention) ]
  46. Change in Strain gradient (με/mm) [ Time Frame: 6 months (pre and post intervention) ]


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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Post-menopausal - at least 12 months since last menstruation and/or hysterectomy, oophorectomy or hormonal contraceptive use

Exclusion Criteria:

  • Existing knee, hip or back injury.
  • Any medical conditions or injuries which exclude participation in an exercise intervention e.g. heart conditions, hypertension
  • BMI > 30 kg/m2
  • Participation in a study involving ionising radiation in the previous 12 months.
  • Exercise involving ground reaction forces greater than that of jogging more than once a week.
  • Contraindications to MRI or DXA
  • Osteoporotic (FRAX score requiring the participant is advised to seek treatment)
  • Medication affecting bone metabolism or density

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225703


Contacts
Contact: Christopher M Hartley, MSC c.hartley@lboro.ac.uk
Contact: Katherine Brooke-Wavell, PhD 01509 222749 k.s.f.brooke-wavell@lboro.ac.uk

Locations
United Kingdom
Loughborough University Recruiting
Loughborough, Leicestershire, United Kingdom, LE11 3TU
Contact: Christopher M Hartley, MSc       c.hartley@lboro.ac.uk   
Contact: Katherine Brooke-Wavell, PhD    01509 222749    k.s.f.brooke-wavell@lboro.ac.uk   
Sub-Investigator: Chris Hartley, MSc         
Principal Investigator: Katherine Brooke-Wavell, PhD         
Sub-Investigator: Jonathan Folland, PhD         
Sub-Investigator: Robert Kerslake         
Sponsors and Collaborators
Loughborough University
Investigators
Principal Investigator: Katherine Brooke-Wavel, PhD Loughborough University

Responsible Party: Katherine Brooke-Wavell, Senior Lecturer in Human Biology, Loughborough University
ClinicalTrials.gov Identifier: NCT03225703     History of Changes
Other Study ID Numbers: R16-P149
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a plan to have scans available on a public database.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Katherine Brooke-Wavell, Loughborough University:
Exercise
Osteoporosis
Osteoarthritis
MRI
DXA
High Impact
Cartilage
Bone

Additional relevant MeSH terms:
Osteoarthritis
Osteoporosis
Osteoarthritis, Knee
Osteoporosis, Postmenopausal
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bone Diseases, Metabolic
Bone Diseases
Metabolic Diseases