Intervention on Bone Health in Wheelchair Users

Not Applicable

Completed

• Conditions: Bone Loss; Spinal Cord Injuries; Dysmelia; Spina Bifida; Cerebral Palsy; Amputation
• Interventions: Other: Bone-specific strength training; Dietary Supplement: Nutrition optimalisation

• Registration Number: NCT05615402
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Study Start: 2022-12-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 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)

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 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
• known other contraindication of resistance exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training group	Nutrition optimalisation	Group A: strength training 3x/week + nutrition optimalisation
Nutrition group	Nutrition optimalisation	Group B: nutrition optimalisation
Training group	Bone-specific strength training	Group A: strength training 3x/week + nutrition optimalisation

Primary Outcome Measures

Name	Time	Method
Bone mineral density of the spine	24-weeks	Z-score for L1-4

Trial Locations

Locations (1)

Norwegian School of Sport Sciences; 🇳🇴 Oslo, Norway