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Intervention on Bone Health in Wheelchair Users (BoneWheel)

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ClinicalTrials.gov Identifier: NCT05615402
Recruitment Status : Recruiting
First Posted : November 14, 2022
Last Update Posted : March 23, 2023
Sunnaas Rehabilitation Hospital
Norwegian University of Science and Technology
HAN University of Applied Sciences
Information provided by (Responsible Party):
Kristin L. Jonvik, Norwegian School of Sport Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Bone Loss Spinal Cord Injuries Cerebral Palsy Spina Bifida Dysmelia Amputation Other: Bone-specific strength training Dietary Supplement: Nutrition optimalisation Not Applicable

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial over 24-weeks.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improving Bone Health in Wheelchair Users by a Long-term Intervention Combining Bone-specific Exercise and Nutrition
Actual Study Start Date : December 1, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Experimental: Training group
Group A: strength training 3x/week + nutrition optimalisation
Other: Bone-specific strength training
Muscular strength and rate of force development (RFD) will be assessed in the key exercises of the intervention protocol

Dietary Supplement: Nutrition optimalisation
Dietary supplement of protein, vitamin D and Calcium 3x/w Dietary counselling based on individual dietary records

Experimental: Nutrition group
Group B: nutrition optimalisation
Dietary Supplement: Nutrition optimalisation
Dietary supplement of protein, vitamin D and Calcium 3x/w Dietary counselling based on individual dietary records

Primary Outcome Measures :
  1. Bone mineral density of the spine [ Time Frame: 24-weeks ]
    Z-score for L1-4

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05615402

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Norwegian School of Sport Sciences Recruiting
Oslo, Norway, 0863
Contact: Kristin L Jonvik, PhD    +4794137624    kristinlj@nih.no   
Contact: Linn C Risvang, MSc    +4790689951    linncr@nih.no   
Sponsors and Collaborators
Norwegian School of Sport Sciences
Sunnaas Rehabilitation Hospital
Norwegian University of Science and Technology
HAN University of Applied Sciences
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Responsible Party: Kristin L. Jonvik, Principal investigator, Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier: NCT05615402    
Other Study ID Numbers: NorwegianSSS BoneWheel
First Posted: November 14, 2022    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Cerebral Palsy
Spinal Dysraphism
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Brain Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities