The Effect of High Impact Exercise on Bone and Articular Cartilage in Post-menopausal Women
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Loughborough University
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Change in T2 Relaxation Time (ms)
Study Overview
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.
Detailed Description
The research is a 6 month, intervention study of unilateral (single limb) exercise with the changes in a randomly chosen exercise leg being compared to those in the other (control) leg.
Potential participants (women aged 55-70) will be approached via existing links in the community, at local community centres, through local media, posters and flyers. After initial contact to determine whether they meet the inclusion/exclusion criteria they will be invited to join the study and sent the participant information sheet (PIS). If they then wish to aid in the research they will be invited to a first meeting at Loughborough University.
At the initial meeting the participant can further discuss the project and PIS with the research team. If they fully understand the project and are happy to take part they will be invited to sign the informed consent form. At this stage each participant will be anonymised using a project code. Screening and baseline measurements will then be taken.
Screening questionnaires will be taken following consent to the study. These include a demographic questionnaire, health screen questionnaire, calcium intake questionnaire, physical activity readiness questionnaire (PAR-Q) and bone physical activity questionnaire (BPAQ).
Dual X-ray Absorptiometry (DXA) scans of the whole body, anterior-posterior (AP) spine and dual femur will be taken for each participant to give baseline measurements of bone mineral density.Standard positioning procedures for the measurement being taken will be utilised to allow the calculation of the T-score.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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 Outcomes
- Change in pBV/rBV (%)(6 months (pre and post intervention))
- Change in Femoral neck bone mineral content (g)(6 months (pre and post intervention))
- Change in Spine bone mineral content (g)(6 months (pre and post intervention))
- Change in BMD(D100) (mg HA/cm3)(6 months (pre and post intervention))
- Change in BV/TV (%)(6 months (pre and post intervention))
- Change in Spine bone mineral density (g/cm2)(6 months (pre and post intervention))
- Change in Ground Reaction force for a set of ten hops (N)(6 months (pre and post intervention))
- Change in Total bone mass (mg)(6 months (pre and post intervention))
- Change in pBV/TV (%)(6 months (pre and post intervention))
- Change in rBV/TV (%)(6 months (pre and post intervention))
- Change in rBV/BV (%)(6 months (pre and post intervention))
- Change in BS/TV (mm-1)(6 months (pre and post intervention))
- Change in Tb.Th (mm)(6 months (pre and post intervention))
- Change in τ(6 months (pre and post intervention))
- Change in Young's Modulus (GPa)(6 months (pre and post intervention))
- Change in Maximal hop height (mm)(6 months (pre and post intervention))
- Change in pBV/BV (%)(6 months (pre and post intervention))
- Change in Tb.Sp (mm)(6 months (pre and post intervention))
- Change in Tb.N (mm-1)(6 months (pre and post intervention))
- Change in SMI(6 months (pre and post intervention))
- Change in BFM (mg)(6 months (pre and post intervention))
- Change in Ct.Th(mm)(6 months (pre and post intervention))
- Change in Stiffness (N/mm)(6 months (pre and post intervention))
- Change in Strain energy density (J/m3)(6 months (pre and post intervention))
- Change in Femoral neck bone mineral density (g/cm2)(6 months (pre and post intervention))
- Change in Postural sway (mm)(6 months (pre and post intervention))
- Change in Ground Reaction force Maximal Hop (N)(6 months (pre and post intervention))
- Change in Tb.Pf(6 months (pre and post intervention))
- Change in BFV (mm3)(6 months (pre and post intervention))
- Change in BRM (mg)(6 months (pre and post intervention))
- Change in BRF (%)(6 months (pre and post intervention))
- Change in BFF(%)(6 months (pre and post intervention))
- Change in Po.Dm(mm)(6 months (pre and post intervention))
- Change in Failure load (N)(6 months (pre and post intervention))
- Change in Mechanical anisotropic ratio(6 months (pre and post intervention))
- Change in Strain gradient (με/mm)(6 months (pre and post intervention))
- Change in Conn.D (mm-3)(6 months (pre and post intervention))
- Change in DA(6 months (pre and post intervention))
- Change in BRV (mm3)(6 months (pre and post intervention))
- Change in BRR(mm3/week)(6 months (pre and post intervention))
- Change in B.Po(%)(6 months (pre and post intervention))
- Change in Bone surface(BS) (mm2)(6 months (pre and post intervention))
- Change in BFR(mm3/week)(6 months (pre and post intervention))
- Change in Trabecular orientation distribution (Tb.O.D) (angle in degrees)(6 months (pre and post intervention))
- Change in Pore volume distribution(6 months (pre and post intervention))
- Change in Strain(6 months (pre and post intervention))
Investigators
Katherine Brooke-Wavell
Senior Lecturer in Human Biology
Loughborough University