The Effect of High Impact Exercise on Bone and Articular Cartilage in Post-menopausal Women
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
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, 2017
CompletedFirst Submitted
Initial submission to the registry
April 5, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJuly 21, 2017
July 1, 2017
1.4 years
April 5, 2017
July 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in T2 Relaxation Time (ms)
T2 mapping is an indicator of the water content in cartilage, with longer relaxation times a marker of cartilage degeneration
6 months (pre and post intervention)
Secondary Outcomes (46)
Change in Femoral neck bone mineral density (g/cm2)
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 density (g/cm2)
6 months (pre and post intervention)
Change in Spine bone mineral content (g)
6 months (pre and post intervention)
Change in Postural sway (mm)
6 months (pre and post intervention)
- +41 more secondary outcomes
Study Arms (2)
Exercise Leg
ACTIVE COMPARATORLeft 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)
Non exercise Leg
NO INTERVENTIONRandomly assigned non-exercise, control leg.
Interventions
Eligibility Criteria
You may qualify if:
- Post-menopausal - at least 12 months since last menstruation and/or hysterectomy, oophorectomy or hormonal contraceptive use
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loughborough University
Loughborough, Leicestershire, LE11 3TU, United Kingdom
Related Publications (1)
Du J, Hartley C, Brooke-Wavell K, Paggiosi MA, Walsh JS, Li S, Silberschmidt VV. High-impact exercise stimulated localised adaptation of microarchitecture across distal tibia in postmenopausal women. Osteoporos Int. 2021 May;32(5):907-919. doi: 10.1007/s00198-020-05714-4. Epub 2020 Nov 16.
PMID: 33196852DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Brooke-Wavel, PhD
Loughborough University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer in Human Biology
Study Record Dates
First Submitted
April 5, 2017
First Posted
July 21, 2017
Study Start
January 1, 2017
Primary Completion
June 1, 2018
Study Completion
January 1, 2019
Last Updated
July 21, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will share
There is a plan to have scans available on a public database.