Intervention on Bone Health in Wheelchair Users (BoneWheel)

• ClinicalTrials.gov Identifier: NCT05615402
• Recruitment Status: Recruiting
• First Posted: November 14, 2022
• Last Update Posted: March 23, 2023
• Sponsor: Norwegian School of Sport Sciences
• Collaborators: 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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Norway

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

More Information

• 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
• Last Update Posted: March 23, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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