Image

Intervention on Bone Health in Wheelchair Users

Recruiting
18 - 60 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

Inclusion Criteria:

  • BMD Z-score of the spine ≤ 0 SD
  • primary aid for mobility being a manual wheelchair, i.e. ≥50% of the time
  • 18-50 Y
  • congenital (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 users
  • injury acquired <2 Y ago
  • change in health and/or medication within the last 3 months
  • fracture within the last 6 months
  • 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
  • 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

Study details

Bone Loss, Spinal Cord Injuries, Cerebral Palsy, Spina Bifida, Dysmelia

NCT05615402

Norwegian School of Sport Sciences

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.