Intervention on Bone Health in Wheelchair Users

NCT05615402 | Completed DMC

• 1 other identifier: NorwegianSSS BoneWheel
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss; Spinal Cord Injuries; Cerebral Palsy; Spina Bifida; Dysmelia; Amputation

Outcome Measures

Primary Outcomes (1)

• Bone mineral density of the spine

  Z-score for L1-4

  24-weeks

Study Arms (2)

Training group

EXPERIMENTAL

Group A: strength training 3x/week + nutrition optimalisation

Other: Bone-specific strength training; Dietary Supplement: Nutrition optimalisation

Nutrition group

EXPERIMENTAL

Group B: nutrition optimalisation

Dietary Supplement: Nutrition optimalisation

Interventions

Bone-specific strength training OTHER

Muscular strength and rate of force development (RFD) will be assessed in the key exercises of the intervention protocol

Training group

Nutrition optimalisation DIETARY_SUPPLEMENT

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

Nutrition group; Training group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMD Z-score of the spine ≤ 0 SD
• primary aid for mobility being a manual wheelchair, i.e. ≥50% of the time
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian School of Sport Sciences: lead
• Sunnaas Rehabilitation Hospital: collaborator
• Norwegian University of Science and Technology: collaborator
• HAN University of Applied Sciences: collaborator

Study Sites (1)

Norwegian School of Sport Sciences

Oslo, 0863, Norway

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Spinal Cord Injuries; Cerebral Palsy; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; 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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled trial over 24-weeks.

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: December 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)