Intervention on Bone Health in Wheelchair Users

Last updated: December 4, 2024
Sponsor: Norwegian School of Sport Sciences
Overall Status: Completed

Phase

N/A

Condition

Osteopenia

Spinal Cord Injuries

Periodontitis

Treatment

Bone-specific strength training

Nutrition optimalisation

Clinical Study ID

NCT05615402
NorwegianSSS BoneWheel
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • 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 acquireddisabilities (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)

Exclusion

Exclusion Criteria:

  • 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 ofthe study

  • • patients with progressive neurological disease, serious or uncontrollableepilepsy, endocrine diseases (including diabetes mellitus type 1 or 2, thyroiddisorders, calcium homeostasis disorders and metabolic bone disease, pituitary glanddisorder, sex hormone disorders), cancer, serious mental disorder, or comorbidmedical conditions affecting either a) nutritional function: i.e., malabsorptionproblems due to previous surgery in the gastrointestinal tract, inflammatory boweldisease, coeliac disease, eating disorders, chronic pancreatitis, liver or kidneydisease (those that cannot convert vitamin D to its active form in the body), otherconditions affecting vitamin D or calcium absorption; b) musculoskeletal system:i.e., congenital systemic skeletal dysplasia affecting bone density, inflammatoryarthritis conditions (such as rheumatoid arthritis, psoriatic arthritis, ankylosingspondylitis, and lupus), ongoing tendinitis or muscle injuries not compatible withthe exercise intervention; c) cardiovascular system: i.e. congenital heart failure,congenital connective tissue disorders affecting the aorta and/or arteries, othercardiovascular conditions not compatible with the exercise intervention;

  • the use of certain medications: bisphosphonates, PTH (teriparatide), Denosumab,Raloksiphen, Prednisolone/steroids/androgenic steroids, high dose oestrogen (including medroxyprogesterone acetate contraceptives) immunosuppressivemedications/ 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, andisotretinoin.

  • 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 affectbone mineral density

  • known other contraindication of resistance exercise.

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: Bone-specific strength training
Phase:
Study Start date:
December 01, 2022
Estimated Completion Date:
July 01, 2024

Study 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:

  1. Bone health, measured as changes in BMD and blood bone markers.

  2. Physical health, including body composition and muscular fitness.

  3. 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.

Connect with a study center

  • Norwegian School of Sport Sciences

    Oslo, 0863
    Norway

    Site Not Available

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