Clinical Trials Directory

Trials / Completed

CompletedNCT05615402

Intervention on Bone Health in Wheelchair Users

Improving Bone Health in Wheelchair Users by a Long-term Intervention Combining Bone-specific Exercise and Nutrition

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Norwegian School of Sport Sciences · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERBone-specific strength trainingMuscular strength and rate of force development (RFD) will be assessed in the key exercises of the intervention protocol
DIETARY_SUPPLEMENTNutrition optimalisationDietary supplement of protein, vitamin D and Calcium 3x/w Dietary counselling based on individual dietary records

Timeline

Start date
2022-12-01
Primary completion
2024-07-01
Completion
2024-07-01
First posted
2022-11-14
Last updated
2024-12-05

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT05615402. Inclusion in this directory is not an endorsement.