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AzTrials

OsteoporosisREPROOFNCT05889598

Resistance Exercise Training to Improve Bone and Articular Cartilage Health in Women

A study testing Ballistic Resistance Lower Body Strength Training and Conventional Resistance Lower Body Strength Training in people with Osteoporosis and Osteoarthritis, run by Loughborough University at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Osteoarthritis (degenerative joint disease) and osteoporosis (weak and fragile bones) are common conditions, particularly in women after menopause, and become even more common as we get older. Aging is also associated with sarcopenia, the progressive loss of muscle strength and mass with age. Read more about this study

Who is it for?
Ages 50 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Osteoporosis, Osteoarthritis
What is being tested?
Ballistic Resistance Lower Body Strength Training and Conventional Resistance Lower Body Strength Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited Kingdom
Study dates
1 Mar 2022to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women between 50-70 years;
  • Experienced last menstrual cycle, hormonal contraception or menopausal hormone replacement therapy at least five years ago;
  • Independent living and able to come into the university;
  • Healthy women: not previously diagnosed with osteoporosis or knee osteoarthritis, other major medical conditions;
  • Able to understand English.

Who cannot join

  • Any existing symptomatic knee, hip, back injury or any medical conditions or injuries which would affect the ability or safety to perform exercise or influence bone/cartilage, including unstable angina, uncontrolled hypertension, a history of heart failure, and a history of cardiovascular disease and conditions;
  • Taking medication affecting bone/cartilage metabolism;
  • Regular (>once per week on average) participation in resistance training with loading greater than bodyweight or in high impact (impact greater than jogging);
  • Blood pressure exceeding 150/90 mmHg;
  • BMI > 30 kg/m2;
  • Contraindications to MRI or DXA (e.g. Metallic implants);
  • Osteoporotic (FRAX score according to which the participant would be advised to seek treatment);
  • Fracture within the past year.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Loughborough University

    Loughborough, Leicestershire, LE11 3TU

Other trials in United Kingdom

About this study

Official title: Effects of a Resistance Exercise Programme on Risk of Osteoporosis and Osteoarthritis in Females

Osteoarthritis (degenerative joint disease) and osteoporosis (weak and fragile bones) are common conditions, particularly in women after menopause, and become even more common as we get older. Aging is also associated with sarcopenia, the progressive loss of muscle strength and mass with age. In this three-arm study, the effect of resistance exercise programs with different parameters (such as velocity and load) on various outcomes, including structural changes (bone mineral density, cartilage composition, muscle size), physical function, and biomarkers will be compared.

Read the detailed description

Resistance exercise is effective in improving several risk factors for osteoporosis and osteoarthritis, and is recommended to prevent and manage both conditions, and is also known to counteract sarcopenia. Overall, there is little and inconsistent evidence on the effects of exercise parameters (such as velocity) for the prevention of osteoporosis and osteoarthritis, neither is there a comparison of different velocities on structural parameters and biomarkers. Although osteoporosis and osteoarthritis take a long time to develop, it is possible to look at changes in risk using scans of bones and joints -Dual-Energy X-ray absorptiometry (DXA), peripheral Quantitative Computed Tomography (pQCT), and Magnetic Resonance Imaging (MRI)-, blood and/or urine samples and symptoms.

This study aims to examine the effect of two different resistance exercise interventions (explosive high-velocity vs high-load low-velocity training) on structural changes on bone, articular knee and/or hip cartilage and muscle, as well as biomarkers.

The study will be a 32-week long randomized controlled trial including two exercise groups and one non-exercising control group.

Screening and baseline measurements will then be taken when anonymization is completed. Once participants have completed baseline testing, participants will be randomly assigned to one of the exercise groups or control groups using a block randomization technique. Participants will choose an envelope, prepared in batches of 11, which will contain a note saying either 'ballistic' or 'conventional or 'control' with a ratio of 4:4:3. This is to allow for greater drop-out in the exercise groups. It is not possible to blind the participant or researchers supervising the intervention to the group allocation.

The required exercise program involves two supervised sessions per week at Loughborough University, each lasting no longer than 60 minutes per session. Each session will involve 30-40 minutes of exercise and time to check any symptoms or queries with participants.

The exercises are designed to strengthen major muscle groups of the trunk and lower body, as well as to load bones that are affected by osteoporosis and the knee and hip joints that are commonly affected by osteoarthritis. Each exercise training session will take 30-40 minutes and include some whole-body warm-up and trunk exercises before completing the two main exercises: a hack squat and calf raise. These two main exercises will be done using resistance (weight training) machines in a dedicated exercise facility. Investigators chose a hack squat machine as it exercises many muscle groups and skeletal sites in one exercise, including the spine and lower limb rather than a small area. Additionally, it supports the spine, making it safe and comfortable to use.

The intervention will be personalized to the individual's ability, and loads will steadily increase as the participant improves. The load will be decided according to maximal muscular strength determined by calculation of 1-repetition maximum which will be renewed every month to monitor the progress of their muscle strength and use of the correct weight for training (in proportion to the strength). Participants will start off using light weights and these will increase as participants become stronger.

The two exercise groups will follow the same exercise programmes but using different speeds and weights: The conventional training group will perform the exercises slowly (conventionally), whilst the ballistic group will use lower loads and higher velocity as if trying to jump. Participants will be carefully guided and coached to perform all the exercises correctly and all the exercise training sessions will be supervised by qualified researchers to ensure safety throughout the study.

The control group will be asked to maintain their usual exercise and diet. Follow-up measurements will take place 16 and 32 weeks after the commencement of the exercise programme.

The sample size calculation is based on detecting differences in bone mineral density between each exercise group and the control group. Using an effect size of 0.75 (considered clinically meaningful), alpha of 0.05, and beta errors of 0.95, approximately 28 participants are needed for each group. However, the final sample size should cover a possible number of withdrawals. To allow for a 30% drop-out rate in exercise groups, 110 participants will be recruited for the study.

All data will be reported in the final work; any missing data will be accounted for with reasons for it missing. All measures described in the methodology will be reported, whether results are statistically significant or not. Data from all eligible participants will be included in an intention-to-treat analysis. Multiple imputation will be used for addressing the presence of missing data. The analysis will be repeated in good adherers i.e. those who attended at least 90% of the exercise sessions.

Descriptive statistics will be calculated to give information on mean values and variation (standard deviation) of the cohort. Normal distribution will be analysed using Shapiro-Wilk test. If variance is shown to be homogenous and distribution normal within the population then repeated measures analysis of variance (RM-ANOVA) will detect any significant differences between group (exercise versus control), time (baseline versus post-intervention) or group x time interaction.

Being tested
Ballistic Resistance Lower Body Strength Training, Conventional Resistance Lower Body Strength Training
Keywords
Exercise, Explosive high-velocity, Bone mineral density, Knee joint, Neuromuscular, Biomarkers
Medical subject headings
Osteoporosis, Osteoarthritis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ballistic Resistance Lower Body Strength TrainingOther

    The exercise programme involves two supervised sessions per week at University. Each session will involve 30-40 minutes of exercise, comprising warm-up , two main exercises: a hack squat and calf raise using a hack squat machine, and core exercises. After a warm-up period involving 5 minutes cycling and one set of 5 conventional repetitions at 40%1RM, the ballistic training group will complete eccentric phase hack squat exercise in approximately 3 seconds and the concentric phase as fast as possible with throwing type contractions. If participants can, participants will be allowed to take off in the concentric phase. To maintain high velocity in this group, lower loads will be used compared to the conventional group. The load will be decided according to regular maximal muscular strength test (1RM) to use of the correct weight for training (in proportion to the strength). Participants will start off using light weights and these will increase as participants become stronger.

  • Conventional Resistance Lower Body Strength TrainingOther

    The exercise programme involves two supervised sessions per week at Loughborough University. Each session will involve 30-40 minutes of exercise, comprising warm-up , two main exercises: a hack squat and calf raise using a hack squat machine, and core exercises. After a warm-up period involving 5 minutes cycling and one set of 5 conventional repetitions at 40% of 1RM, the conventional training group will complete eccentric and concentric phases of hack squatting exercises for approximately 3 seconds each, with appropriate breathing techniques. The load will be decided according to regular maximal muscular strength test (1RM) to use of the correct weight for training (in proportion to the strength). Participants will start off using light weights and these will increase as participants become stronger.

Study groups in NCT05889598
Study groupRoleWhat they receive
Ballistic resistance exercise trainingExperimentalThis arm will perform the exercises in a hack squat machine using low loads and explosive high-velocity (as if trying to jump)
Receives: Other: Ballistic Resistance Lower Body Strength Training
Conventional resistance exercise trainingExperimentalThis arm will perform the exercises in a hack squat machine using high-load and low-velocity (conventional training)
Receives: Other: Conventional Resistance Lower Body Strength Training
ControlNo interventionContinue usual life

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Femoral neck bone mineral content from baseline

    (g) measured by DXA

    Measured: 32nd week

  2. Change in Femoral neck bone mineral density from baseline

    (g/cm^2) measured by DXA

    Measured: 32nd week

Secondary outcomes (40)
  1. Bone Mineral Content (Femur)

    Proximal Femur bone will be assessed in "g" by DXA

    Measured: Baseline, 16th and 32nd weeks

  2. Bone Mineral Density (Femur)

    Proximal femur bone will be assessed (g/cm^2) by DXA

    Measured: Baseline, 16th and 32nd weeks

  3. Bone Mineral Content (Spine)

    Lumbar spine bone will be assessed (g) by DXA

    Measured: Baseline, 16th and 32nd weeks

  4. Bone Mineral Density (Spine)

    Lumbar spine will be assessed (g/cm^2) by DXA

    Measured: Baseline, 16th and 32nd weeks

  5. bone mineral content (Forearm)

    Forearm bone will be assessed (g) by DXA

    Measured: Baseline, 16th and 32nd weeks

  6. bone mineral density (Forearm)

    Forearm bone will be assessed (g/cm^2) by DXA

    Measured: Baseline, 16th and 32nd weeks

  7. Bone mineral content (Lower leg)

    Tibia bone will be assessed (g) by DXA

    Measured: Baseline, 16th and 32nd weeks

  8. bone mineral density (Lower Leg)

    Tibia bone will be assessed (g/cm^2) by DXA

    Measured: Baseline, 16th and 32nd weeks

  9. Bone mineral content (Total body)

    Whole body will be assessed (g) by DXA

    Measured: Baseline, 16th and 32nd weeks

  10. bone mineral density (Total Body)

    Whole body will be assessed (g/cm^2) by DXA

    Measured: Baseline, 16th and 32nd weeks

  11. cortical bone subdensity (Forearm)

    Radius bone 4% (mg/cm^3) measured by pQCT

    Measured: Baseline, 16th and 32nd weeks

  12. total bone density (Forearm)

    Radius bone 4% (mg/cm^3) measured by pQCT

    Measured: Baseline, 16th and 32nd weeks

  13. trabecular bone density (Forearm)

    Radius bone 4% (mg/cm^3) measured by pQCT

    Measured: Baseline, 16th and 32nd weeks

  14. bone total density (Forearm)

    Radius bone 66% (mg/cm^3) measured by pQCT

    Measured: Baseline, 16th and 32nd weeks

  15. cortical bone density (Forearm)

    Radius bone 66% (mg/cm^3) measured by pQCT

    Measured: Baseline, 16th and 32nd weeks

  16. total bone density (Lower leg)

    Tibia bone 4% (mg/cm^3) measured by pQCT

    Measured: Baseline, 16th and 32nd weeks

  17. trabecular bone density (Lower leg)

    Tibia bone 4% (mg/cm^3) measured by pQCT

    Measured: Baseline, 16th and 32nd weeks

  18. cortical bone subdensity (Lower leg)

    Tibia bone 4% (mg/cm^3) measured by pQCT

    Measured: Baseline, 16th and 32nd weeks

  19. bone total density (Lower leg)

    Tibia bone 38% (mg/cm^3) measured by pQCT

    Measured: Baseline, 16th and 32nd weeks

  20. cortical bone density (Lower leg)

    Tibia bone 38% (mg/cm^3) measured by pQCT

    Measured: Baseline, 16th and 32nd weeks

  21. total bone density (66% of Lower leg)

    Tibia bone 66% (mg/cm^3) measured by pQCT

    Measured: Baseline, 16th and 32nd weeks

  22. cortical density (Lower leg)

    Tibia bone 66% (mg/cm^3) measured by pQCT

    Measured: Baseline, 16th and 32nd weeks

  23. T2 relaxation time

    Knee joint cartilage (ms) measured by MRI

    Measured: Baseline and 32nd week

  24. cartilage thickness

    Knee joint cartilage (mm) measured by MRI

    Measured: Baseline and 32nd week

  25. Change in bone turnover markers (CTX-1 and PINP) in bodily samples

    Serum/urine will be analysed by ELISA kits

    Measured: Baseline, 16th and 32nd weeks

  26. Change in serum biomarkers (OPG, DKK1, irisin, IL-6, C2C, PIICP) in serum samples (exploratory, post hoc)

    Additional serum biomarkers, including osteoprotegerin (OPG), dickkopf Wnt signalling pathway inhibitor 1 (DKK1), irisin, interleukin-6 (IL-6), type II collagen cleavage neoepitope (C2C), and procollagen type II C-propeptide (PIICP), were assessed by ELISA kits.

    These biomarkers were not pre-specified in the original trial registration. Blood samples had been collected during the study period prior to database lock. The decision to include these biomarkers was made after trial completion, and analyses are considered exploratory.

    Measured: Baseline, 16th and 32nd weeks

  27. Lower limb power

    (W) measured during Hack squat action

    Measured: Baseline, 16th and 32nd weeks

  28. Lower limb force

    (N) measured during Hack squat action

    Measured: Baseline, 16th and 32nd weeks

  29. Lower limb velocity

    (m/s) measured during Hack squat action

    Measured: Baseline, 16th and 32nd weeks

  30. Quadriceps cross-sectional area

    (cm^2) measured by MRI

    Measured: Baseline and 32nd week

  31. Triceps surae cross-sectional area

    (cm^2) measured by pQCT

    Measured: Baseline and 32nd week

  32. Lower extremity functioning

    (total score in points) using Short Physical Performance Battery. SPPB scores range from zero to 12 possible points. SPPB score of 10 or greater for persons with no mobility disability indicates robustness.

    Measured: Baseline, 16th and 32nd weeks

  33. Mobility/agility

    The timed Up and Go test is rated on a scale from 1 to 5 where 1 indicates "normal function" and 5 indicates "severely abnormal function"

    Measured: Baseline, 16th and 32nd weeks

  34. Pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life following knee injury

    the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be used for that. A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems

    Measured: Baseline, 16th and 32nd weeks

  35. Pain, stiffness, and physical function of the hip and knee

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

    Measured: Baseline, 16th and 32nd weeks

  36. Physical Activity Level

    Bone-specific Physical Activity Questionnaire (BPAQ). higher scores mean higher physical and better outcomes for the study

    Measured: Baseline, 16th and 32nd weeks

  37. Physical activity and inactivity level

    International Physical Activity Questionnaire (IPAQ)

    Measured: Baseline, 16th and 32nd weeks

  38. Daily calcium intake

    (mg) Calcium Questionnaire

    Measured: Baseline, 16th and 32nd weeks

  39. Static postural sway

    anterior-posterior and medial-lateral mean velocity (cm/s) of the centre of pressure

    Measured: Baseline, 16th and 32nd weeks

  40. Static postural sway (elliptical area)

    the elliptical area (cm^2) will be assessed

    Measured: Baseline, 16th and 32nd weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study start1 Mar 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05889598
Sponsor's protocol ID
304156
Acronym
REPROOF
Status last verified
Apr 2026
First submitted
26 Apr 2022
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Marques EA, Caliskan O, Brooke-Wavell K, Folland J. Feasibility of ballistic vs conventional resistance training in healthy postmenopausal women: A three-arm parallel randomised controlled trial. Maturitas. 2025 May;196:108246. doi: 10.1016/j.maturitas.2025.108246. Epub 2025 Mar 13.

    PubMed 40106971

Questions about this trial

What is this clinical trial studying?

A study testing Ballistic Resistance Lower Body Strength Training and Conventional Resistance Lower Body Strength Training in people with Osteoporosis and Osteoarthritis, run by Loughborough University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Femoral neck bone mineral content from baseline (time frame: 32nd week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05889598, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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