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Recruiting NCT05615402

Intervention on Bone Health in Wheelchair Users

Conditions: Bone Loss, Spinal Cord Injuries, Cerebral Palsy, Spina Bifida, Dysmelia, Amputation

Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 60
Sponsor: Norwegian School of Sport Sciences

Location: Norway

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 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.

Eligibility Criteria

Inclusion Criteria:BMD Z-score of the spine ≤ 0 SDprimary aid for mobility being a manual wheelchair, i.e. ≥50% of the time18-50 Ycongenital (i.e., CP, spina bifida, dysmelia, hip dysplasia) and acquired disabilities (i.e., SCI, amputation)paraplegic wheelchair users with SCI level at Th6 or lower (or higher partial SCI)ability to perform key exercises (e.g., overhead press)Exclusion Criteria:tetraplegic wheelchair usersinjury acquired <2 Y agochange in health and/or medication within the last 3 monthsfracture within the last 6 monthspregnancy or planned pregnancy during the study periodlanguage or cognitive barriers affecting the ability to understand all aspects of the studypatients 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 interventionthe 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 isotretinoinother 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05615402). StuddyBuddy aggregates publicly available trial information.