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.
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
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.
- Conditions
- Osteoporosis, Osteoarthritis
- 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 group | Role | What they receive |
|---|---|---|
| Ballistic resistance exercise training | Experimental | This 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 training | Experimental | This 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 |
| Control | No intervention | Continue usual life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Femoral neck bone mineral content from baseline
(g) measured by DXA
Measured: 32nd week
Change in Femoral neck bone mineral density from baseline
(g/cm^2) measured by DXA
Measured: 32nd week
Secondary outcomes (40)
Bone Mineral Content (Femur)
Proximal Femur bone will be assessed in "g" by DXA
Measured: Baseline, 16th and 32nd weeks
Bone Mineral Density (Femur)
Proximal femur bone will be assessed (g/cm^2) by DXA
Measured: Baseline, 16th and 32nd weeks
Bone Mineral Content (Spine)
Lumbar spine bone will be assessed (g) by DXA
Measured: Baseline, 16th and 32nd weeks
Bone Mineral Density (Spine)
Lumbar spine will be assessed (g/cm^2) by DXA
Measured: Baseline, 16th and 32nd weeks
bone mineral content (Forearm)
Forearm bone will be assessed (g) by DXA
Measured: Baseline, 16th and 32nd weeks
bone mineral density (Forearm)
Forearm bone will be assessed (g/cm^2) by DXA
Measured: Baseline, 16th and 32nd weeks
Bone mineral content (Lower leg)
Tibia bone will be assessed (g) by DXA
Measured: Baseline, 16th and 32nd weeks
bone mineral density (Lower Leg)
Tibia bone will be assessed (g/cm^2) by DXA
Measured: Baseline, 16th and 32nd weeks
Bone mineral content (Total body)
Whole body will be assessed (g) by DXA
Measured: Baseline, 16th and 32nd weeks
bone mineral density (Total Body)
Whole body will be assessed (g/cm^2) by DXA
Measured: Baseline, 16th and 32nd weeks
cortical bone subdensity (Forearm)
Radius bone 4% (mg/cm^3) measured by pQCT
Measured: Baseline, 16th and 32nd weeks
total bone density (Forearm)
Radius bone 4% (mg/cm^3) measured by pQCT
Measured: Baseline, 16th and 32nd weeks
trabecular bone density (Forearm)
Radius bone 4% (mg/cm^3) measured by pQCT
Measured: Baseline, 16th and 32nd weeks
bone total density (Forearm)
Radius bone 66% (mg/cm^3) measured by pQCT
Measured: Baseline, 16th and 32nd weeks
cortical bone density (Forearm)
Radius bone 66% (mg/cm^3) measured by pQCT
Measured: Baseline, 16th and 32nd weeks
total bone density (Lower leg)
Tibia bone 4% (mg/cm^3) measured by pQCT
Measured: Baseline, 16th and 32nd weeks
trabecular bone density (Lower leg)
Tibia bone 4% (mg/cm^3) measured by pQCT
Measured: Baseline, 16th and 32nd weeks
cortical bone subdensity (Lower leg)
Tibia bone 4% (mg/cm^3) measured by pQCT
Measured: Baseline, 16th and 32nd weeks
bone total density (Lower leg)
Tibia bone 38% (mg/cm^3) measured by pQCT
Measured: Baseline, 16th and 32nd weeks
cortical bone density (Lower leg)
Tibia bone 38% (mg/cm^3) measured by pQCT
Measured: Baseline, 16th and 32nd weeks
total bone density (66% of Lower leg)
Tibia bone 66% (mg/cm^3) measured by pQCT
Measured: Baseline, 16th and 32nd weeks
cortical density (Lower leg)
Tibia bone 66% (mg/cm^3) measured by pQCT
Measured: Baseline, 16th and 32nd weeks
T2 relaxation time
Knee joint cartilage (ms) measured by MRI
Measured: Baseline and 32nd week
cartilage thickness
Knee joint cartilage (mm) measured by MRI
Measured: Baseline and 32nd week
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
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
Lower limb power
(W) measured during Hack squat action
Measured: Baseline, 16th and 32nd weeks
Lower limb force
(N) measured during Hack squat action
Measured: Baseline, 16th and 32nd weeks
Lower limb velocity
(m/s) measured during Hack squat action
Measured: Baseline, 16th and 32nd weeks
Quadriceps cross-sectional area
(cm^2) measured by MRI
Measured: Baseline and 32nd week
Triceps surae cross-sectional area
(cm^2) measured by pQCT
Measured: Baseline and 32nd week
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
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
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
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
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
Physical activity and inactivity level
International Physical Activity Questionnaire (IPAQ)
Measured: Baseline, 16th and 32nd weeks
Daily calcium intake
(mg) Calcium Questionnaire
Measured: Baseline, 16th and 32nd weeks
Static postural sway
anterior-posterior and medial-lateral mean velocity (cm/s) of the centre of pressure
Measured: Baseline, 16th and 32nd weeks
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.
- First posted5 Jun 2023
- Study start1 Mar 2022
- Primary completion31 Dec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Versus Arthritis
- Responsible party
- Principal investigator, Katherine Brooke-Wavell, Loughborough University
- Investigators
- Katherine Brooke-Wavell, PhD, Principal investigator, Loughborough UniversityJonathan Folland, PhD, Principal investigator, Loughborough University
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Resistance Exercise Programme on Risk of Osteoporosis and Osteoarthritis in Females
- ClinicalTrials.gov ID
- NCT05889598
- Acronym / sponsor ID
- REPROOF / 304156
- Conditions
- Osteoporosis, Osteoarthritis
- Keywords
- Exercise, Explosive high-velocity, Bone mineral density, Knee joint, Neuromuscular, Biomarkers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Versus Arthritis
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ballistic resistance exercise training | Experimental | Other: Ballistic Resistance Lower Body Strength TrainingThis arm will perform the exercises in a hack squat machine using low loads and explosive high-velocity (as if trying to jump) |
| Conventional resistance exercise training | Experimental | Other: Conventional Resistance Lower Body Strength TrainingThis arm will perform the exercises in a hack squat machine using high-load and low-velocity (conventional training) |
| Control | No intervention | –Continue usual life |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ballistic Resistance Lower Body Strength TrainingThe 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. | Other | Ballistic resistance exercise training |
| Conventional Resistance Lower Body Strength TrainingThe 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. | Other | Conventional resistance exercise training |
Primary outcome
Change in Femoral neck bone mineral content from baseline
Time frame: 32nd week
(g) measured by DXA
Change in Femoral neck bone mineral density from baseline
Time frame: 32nd week
(g/cm^2) measured by DXA
40 secondary outcomes
Bone Mineral Content (Femur)
Time frame: Baseline, 16th and 32nd weeks
Bone Mineral Density (Femur)
Time frame: Baseline, 16th and 32nd weeks
Bone Mineral Content (Spine)
Time frame: Baseline, 16th and 32nd weeks
Bone Mineral Density (Spine)
Time frame: Baseline, 16th and 32nd weeks
bone mineral content (Forearm)
Time frame: Baseline, 16th and 32nd weeks
bone mineral density (Forearm)
Time frame: Baseline, 16th and 32nd weeks
Bone mineral content (Lower leg)
Time frame: Baseline, 16th and 32nd weeks
bone mineral density (Lower Leg)
Time frame: Baseline, 16th and 32nd weeks
Bone mineral content (Total body)
Time frame: Baseline, 16th and 32nd weeks
bone mineral density (Total Body)
Time frame: Baseline, 16th and 32nd weeks
cortical bone subdensity (Forearm)
Time frame: Baseline, 16th and 32nd weeks
total bone density (Forearm)
Time frame: Baseline, 16th and 32nd weeks
trabecular bone density (Forearm)
Time frame: Baseline, 16th and 32nd weeks
bone total density (Forearm)
Time frame: Baseline, 16th and 32nd weeks
cortical bone density (Forearm)
Time frame: Baseline, 16th and 32nd weeks
total bone density (Lower leg)
Time frame: Baseline, 16th and 32nd weeks
trabecular bone density (Lower leg)
Time frame: Baseline, 16th and 32nd weeks
cortical bone subdensity (Lower leg)
Time frame: Baseline, 16th and 32nd weeks
bone total density (Lower leg)
Time frame: Baseline, 16th and 32nd weeks
cortical bone density (Lower leg)
Time frame: Baseline, 16th and 32nd weeks
total bone density (66% of Lower leg)
Time frame: Baseline, 16th and 32nd weeks
cortical density (Lower leg)
Time frame: Baseline, 16th and 32nd weeks
T2 relaxation time
Time frame: Baseline and 32nd week
cartilage thickness
Time frame: Baseline and 32nd week
Change in bone turnover markers (CTX-1 and PINP) in bodily samples
Time frame: Baseline, 16th and 32nd weeks
Change in serum biomarkers (OPG, DKK1, irisin, IL-6, C2C, PIICP) in serum samples (exploratory, post hoc)
Time frame: Baseline, 16th and 32nd weeks
Lower limb power
Time frame: Baseline, 16th and 32nd weeks
Lower limb force
Time frame: Baseline, 16th and 32nd weeks
Lower limb velocity
Time frame: Baseline, 16th and 32nd weeks
Quadriceps cross-sectional area
Time frame: Baseline and 32nd week
Triceps surae cross-sectional area
Time frame: Baseline and 32nd week
Lower extremity functioning
Time frame: Baseline, 16th and 32nd weeks
Mobility/agility
Time frame: Baseline, 16th and 32nd weeks
Pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life following knee injury
Time frame: Baseline, 16th and 32nd weeks
Pain, stiffness, and physical function of the hip and knee
Time frame: Baseline, 16th and 32nd weeks
Physical Activity Level
Time frame: Baseline, 16th and 32nd weeks
Physical activity and inactivity level
Time frame: Baseline, 16th and 32nd weeks
Daily calcium intake
Time frame: Baseline, 16th and 32nd weeks
Static postural sway
Time frame: Baseline, 16th and 32nd weeks
Static postural sway (elliptical area)
Time frame: Baseline, 16th and 32nd weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 40106971Marques 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.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Brooke-Wavell, PhD principal investigator
Loughborough University
Jonathan Folland, PhD principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
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.