Bone LossBoneWheelNCT05615402
Intervention on Bone Health in Wheelchair Users
A study testing Bone-specific strength training and Nutrition optimalisation in people with Bone Loss and Spinal Cord Injuries, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial summary
The low mechanical loading of bones among wheelchair users leads to an increased risk of bone fractures and associated complications due to low bone mineral density (BMD). Adding mechanical loading through physical activity in combination with optimizing nutrition may counteract these negative consequences in… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Spinal Cord Injuries, Cerebral Palsy
- What is being tested?
- Bone-specific strength training and Nutrition optimalisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNorway
- Study dates
- 1 Dec 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMD Z-score of the spine ≤ 0 SD
- primary aid for mobility being a manual wheelchair, i.e. ≥50% of the time
- 18-60 Y
- congenital (i.e., CP, spina bifida, dysmelia, hip dysplasia) and acquired disabilities (i.e., SCI, amputation)
- non-progressive impairment, and in the case of SCI; ≥ 2 years since time of injury
- ability to perform key exercises (e.g., overhead press)
Who cannot join
- injury acquired <2 Y ago
- change in health and/or medication within the last 3 months
- fractures affecting measured sites or contraindicating strength testing/training
- menopausal, pregnancy or planned pregnancy during the study period
- language or cognitive barriers affecting the ability to understand all aspects of the study
- • patients with progressive neurological disease, serious or uncontrollable epilepsy, endocrine diseases (including diabetes mellitus type 1 or 2, thyroid disorders, calcium homeostasis disorders and metabolic bone disease, pituitary gland disorder, sex hormone disorders), cancer, serious mental disorder, or comorbid medical conditions affecting either a) nutritional function: i.e., malabsorption problems due to previous surgery in the gastrointestinal tract, inflammatory bowel disease, coeliac disease, eating disorders, chronic pancreatitis, liver or kidney disease (those that cannot convert vitamin D to its active form in the body), other conditions affecting vitamin D or calcium absorption; b) musculoskeletal system: i.e., congenital systemic skeletal dysplasia affecting bone density, inflammatory arthritis conditions (such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and lupus), ongoing tendinitis or muscle injuries not compatible with the exercise intervention; c) cardiovascular system: i.e. congenital heart failure, congenital connective tissue disorders affecting the aorta and/or arteries, other cardiovascular conditions not compatible with the exercise intervention;
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- the use of certain medications: bisphosphonates, PTH (teriparatide), Denosumab, Raloksiphen, Prednisolone/steroids/androgenic steroids, high dose oestrogen (including medroxyprogesterone acetate contraceptives) immunosuppressive medications/ chemotherapies, vitamin K, anti-epileptic medication (Lamotrigine, Phenytoin, Phenobarbital, Carbamazepine, Primidone), proton pump inhibitors (PPIs), selective serotonin receptor inhibitors (SSRIs), thiazolidinediones (TZDs), anticonvulsants, hormone deprivation therapy, calcineurin inhibitors, and isotretinoin.
- other therapies that aim to increase bone mineral density, e.g., vibration therapy, functional electrical stimulation (FES)
- alternative medicine that interfere with vitamin D or calcium metabolism or affect bone mineral density
- known other contraindication of resistance exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Bone Health in Wheelchair Users by a Long-term Intervention Combining Bone-specific Exercise and Nutrition
The low mechanical loading of bones among wheelchair users leads to an increased risk of bone fractures and associated complications due to low bone mineral density (BMD). Adding mechanical loading through physical activity in combination with optimizing nutrition may counteract these negative consequences in wheelchair users and thereby provide positive impact for bone health, as well as for physical and mental health.
In this project, a multidisciplinary team will tailor a bone-specific exercise and nutrition program to increase BMD in sport active and non-active wheelchair users with initial low BMD.
Read the detailed description
The primary aim of this project is to investigate the effects of combined exercise training with high mechanical loading of bones and nutritional counselling for improving bone health in wheelchair users with an initially low-normal to low BMD (Z-score ≤ 0.0). Specifically, the following objectives are to determine the effects of the intervention on:
- Bone health, measured as changes in BMD and blood bone markers.
- Physical health, including body composition and muscular fitness.
- Mental health, with focus on well-being, QOL and user experience.
The secondary aim is to use this knowledge to develop recommendations and implementation plans for exercise and nutrition to promote bone health of wheelchair users.
Using a randomized controlled design, participants will undergo an exercise intervention in which the participants also will receive nutritional optimization for bone remodelling. Main outcomes are change in BMD, blood bone markers, physical health and mental health parameters. Based on the outcomes of the RCT, the researchers will develop evidence-based practical health promoting recommendations and an implementation plan for health practitioners working with wheelchair users in the municipalities.
- Conditions
- Bone Loss, Spinal Cord Injuries, Cerebral Palsy, Spina Bifida, Dysmelia, Amputation
- Being tested
- Bone-specific strength training, Nutrition optimalisation
- Medical subject headings
- Bone Diseases, Metabolic, Spinal Cord Injuries, Cerebral Palsy, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone-specific strength trainingOther
Muscular strength and rate of force development (RFD) will be assessed in the key exercises of the intervention protocol
Nutrition optimalisationDietary supplement
Dietary supplement of protein, vitamin D and Calcium 3x/w Dietary counselling based on individual dietary records
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Group A: strength training 3x/week + nutrition optimalisation Receives: Other: Bone-specific strength training; Dietary Supplement: Nutrition optimalisation |
| Nutrition group | Experimental | Group B: nutrition optimalisation Receives: Dietary Supplement: Nutrition optimalisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density of the spine
Z-score for L1-4
Measured: 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Dec 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
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 Bone LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial over 24-weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnaas Rehabilitation Hospital, Norwegian University of Science and Technology, HAN University of Applied Sciences
- Responsible party
- Principal investigator, Kristin L. Jonvik, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615402
- Sponsor's protocol ID
- NorwegianSSS BoneWheel
- Acronym
- BoneWheel
- Status last verified
- Dec 2024
- First submitted
- 7 Nov 2022
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Risvang LC, van Dijk JW, Baumgart JK, Rice HM, Liljegren AMF, Strom V, Raastad T, Jonvik KL. High prevalence of low bone mineral density in wheelchair users regardless of sports participation: a cross-sectional analysis of the bonewheel study. Eur J Appl Physiol. 2026 May;126(5):2879-2892. doi: 10.1007/s00421-025-06109-1. Epub 2025 Dec 24.
PubMed 41442093
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Bone Health in Wheelchair Users by a Long-term Intervention Combining Bone-specific Exercise and Nutrition
- ClinicalTrials.gov ID
- NCT05615402
- Acronym / sponsor ID
- BoneWheel / NorwegianSSS BoneWheel
- Conditions
- Bone Loss, Spinal Cord Injuries, Cerebral Palsy, Spina Bifida, Dysmelia, Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- Sunnaas Rehabilitation Hospital, Norwegian University of Science and Technology, HAN University of Applied Sciences
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 14 Nov 2022 (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.
The low mechanical loading of bones among wheelchair users leads to an increased risk of bone fractures and associated complications due to low bone mineral density (BMD). Adding mechanical loading through physical activity in combination with optimizing nutrition may counteract these negative consequences in wheelchair users and thereby provide positive impact for bone health, as well as for physical and mental health.
In this project, a multidisciplinary team will tailor a bone-specific exercise and nutrition program to increase BMD in sport active and non-active wheelchair users with initial low BMD.
Detailed description
The primary aim of this project is to investigate the effects of combined exercise training with high mechanical loading of bones and nutritional counselling for improving bone health in wheelchair users with an initially low-normal to low BMD (Z-score ≤ 0.0). Specifically, the following objectives are to determine the effects of the intervention on:
- Bone health, measured as changes in BMD and blood bone markers.
- Physical health, including body composition and muscular fitness.
- Mental health, with focus on well-being, QOL and user experience.
The secondary aim is to use this knowledge to develop recommendations and implementation plans for exercise and nutrition to promote bone health of wheelchair users.
Using a randomized controlled design, participants will undergo an exercise intervention in which the participants also will receive nutritional optimization for bone remodelling. Main outcomes are change in BMD, blood bone markers, physical health and mental health parameters. Based on the outcomes of the RCT, the researchers will develop evidence-based practical health promoting recommendations and an implementation plan for health practitioners working with wheelchair users in the municipalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial over 24-weeks.
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Bone-specific strength training, Dietary Supplement: Nutrition optimalisationGroup A: strength training 3x/week + nutrition optimalisation |
| Nutrition group | Experimental | Dietary Supplement: Nutrition optimalisationGroup B: nutrition optimalisation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMD Z-score of the spine ≤ 0 SD
- primary aid for mobility being a manual wheelchair, i.e. ≥50% of the time
- 18-60 Y
- congenital (i.e., CP, spina bifida, dysmelia, hip dysplasia) and acquired disabilities (i.e., SCI, amputation)
- non-progressive impairment, and in the case of SCI; ≥ 2 years since time of injury
Key exclusion criteria (10 listed)
- injury acquired <2 Y ago
- change in health and/or medication within the last 3 months
- fractures affecting measured sites or contraindicating strength testing/training
- menopausal, pregnancy or planned pregnancy during the study period
- language or cognitive barriers affecting the ability to understand all aspects of the study
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 |
|---|---|---|
| Bone-specific strength trainingMuscular strength and rate of force development (RFD) will be assessed in the key exercises of the intervention protocol | Other | Training group |
| Nutrition optimalisationDietary supplement of protein, vitamin D and Calcium 3x/w Dietary counselling based on individual dietary records | Dietary supplement | Nutrition group, Training group |
Primary outcome
Bone mineral density of the spine
Time frame: 24-weeks
Z-score for L1-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 41442093Risvang LC, van Dijk JW, Baumgart JK, Rice HM, Liljegren AMF, Strom V, Raastad T, Jonvik KL. High prevalence of low bone mineral density in wheelchair users regardless of sports participation: a cross-sectional analysis of the bonewheel study. Eur J Appl Physiol. 2026 May;126(5):2879-2892. doi: 10.1007/s00421-025-06109-1. Epub 2025 Dec 24.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone-specific strength training and Nutrition optimalisation in people with Bone Loss and Spinal Cord Injuries, run by Norwegian School of Sport Sciences at 1 site in Norway.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 5 Dec 2024. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone mineral density of the spine (time frame: 24-weeks). 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 NCT05615402, 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 5 Dec 2024.