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Intervention on Bone Health in Wheelchair Users (BoneWheel)

Primary Purpose

Bone Loss, Spinal Cord Injuries, Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Bone-specific strength training
Nutrition optimalisation
Sponsored by
Norwegian School of Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Norwegian School of Sport SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Training group

Nutrition group

Arm Description

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

Group B: nutrition optimalisation

Outcomes

Primary Outcome Measures

Bone mineral density of the spine
Z-score for L1-4

Secondary Outcome Measures

Full Information

First Posted
November 7, 2022
Last Updated
March 22, 2023
Sponsor
Norwegian School of Sport Sciences
Collaborators
Sunnaas Rehabilitation Hospital, Norwegian University of Science and Technology, HAN University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05615402
Brief Title
Intervention on Bone Health in Wheelchair Users
Acronym
BoneWheel
Official Title
Improving Bone Health in Wheelchair Users by a Long-term Intervention Combining Bone-specific Exercise and Nutrition
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian School of Sport Sciences
Collaborators
Sunnaas Rehabilitation Hospital, Norwegian University of Science and Technology, HAN University of Applied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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: Bone health, measured as changes in BMD and blood bone markers. Physical health, including body composition and muscular fitness. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss, Spinal Cord Injuries, Cerebral Palsy, Spina Bifida, Dysmelia, Amputation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial over 24-weeks.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training group
Arm Type
Experimental
Arm Description
Group A: strength training 3x/week + nutrition optimalisation
Arm Title
Nutrition group
Arm Type
Experimental
Arm Description
Group B: nutrition optimalisation
Intervention Type
Other
Intervention Name(s)
Bone-specific strength training
Intervention Description
Muscular strength and rate of force development (RFD) will be assessed in the key exercises of the intervention protocol
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition optimalisation
Intervention Description
Dietary supplement of protein, vitamin D and Calcium 3x/w Dietary counselling based on individual dietary records
Primary Outcome Measure Information:
Title
Bone mineral density of the spine
Description
Z-score for L1-4
Time Frame
24-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Norwegian School of Sport Sciences
City
Oslo
ZIP/Postal Code
0863
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin L Jonvik, PhD
Phone
+4794137624
Email
kristinlj@nih.no
First Name & Middle Initial & Last Name & Degree
Linn C Risvang, MSc
Phone
+4790689951
Email
linncr@nih.no

12. IPD Sharing Statement

Plan to Share IPD
No

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Intervention on Bone Health in Wheelchair Users

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