Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health

Study Overview
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Brief Summary
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The aim of this clinical trial is to investigate the effect of the OsteoStrong training method and the Individually Adapted and Combined Training on the bone health of older women with high fracture risk. Additionally, the aim is also to explore the participants' experiences of each training method. Participants will be randomised to either treatment arm A (OsteoStrong) or treatment arm B (Individually Adapted and Combined Training). Participants in both groups will train for nine months. Treatment arm A will train individually once a week and treatment arm B will train in a group twice a week. Both groups will have a training instructor who will supervise and give training instructions. Researchers will compare the groups to see the effects of the training methods on the participants' bone health among other outcome measures. The participants will be tested at baseline and post-intervention (9 months later).

Official Title
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Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health Amongst Older Women With High Fracture Risk: A Randomised Controlled Trial

Conditions
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Osteoporosis, Osteopenia, Bone Density, Low, Bone Loss

Intervention / Treatment
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* Other: OsteoStrong
* Other: Individually Adapted and Combined Physical Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman, 65-79 years old. Vaccinated against Covid-19. Be able to participate in nine months of training. Untreated with Osteoporosis-medications, or have an ongoing treatment since at least one year back. Exclusion Criteria: Ongoing treatment with Osteoporosis-medications with an onset within a year, or a previous treatment which was terminated within the last five years. Ongoing treatment with Osteoporosis-medications that has been delayed for more than eight months for Denosumab, or more than 18 months for bisphosphonates. Vertebral fracture, that have been diagnosed within three months. Vertebral fracture or hip fracture, that have not previously been treated with Osteoporosis-medications or been assessed by a physician. Bilateral hip replacements. Symptomatic disc herniation, inguinal herniation or umbilical herniation. Untreated hypertension. Other diseases that can affect the results and participation in the study: malignant diseases, muscle dystrophy, secondary osteoporosis, or other conditions that would hinder study participation. Ongoing treatment with oral cortisone pills (≥ 5 mg Prednisolone). Conditions that hinders the conduction of impact microindentation with OsteoProbe: large edema, skin infection, allergy towards local anaesthetics. Ongoing or previous training (within the last year) at OsteoStrong.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OsteoStrong<br>Training following the OsteoStrong-method. | Other: OsteoStrong<br>* This training method is an isometric high-impact loading in four different training machines (Spectrum) and balance training on a vibration plate. The four machines are chest press, leg press, pull-down and deadlift. The participants press and/or pull isometrically for around 10-15 seconds 1-3 times on every machine. The training session takes around 20 minutes and is performed individually by the participants with the help of a training instructor.<br>|
| Active Comparator: Individually Adapted and Combined Physical Training<br>Training based on current recommendations on exercise for people with osteoporosis. | Other: Individually Adapted and Combined Physical Training<br>* This training method is based on the current recommendations on physical activity for people with osteoporosis. The training is divided into two training sessions: Circuit training with ten stations with different exercises for the whole body (strength, balance, endurance, weight-bearing). The participants spend 40 seconds on each station. This is repeated during 40 minutes. The training session starts with a joint warm-up and ends with a cool-down. Strength training with machines for the whole body with the intensity of up to 70-80 % of one repetition max (1RM). The training session starts with a joint warm-up and and a voluntary individual cool-down. The training session takes around 60 minutes and is performed in a group with the help of a training instructor. The participants also have the option to do a home based exercise programme that they could do in a few cases when they were unable to attend the physical group training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Material Strength Index (BMSI) | Bone Material Strength Index measured with impact microindentation using OsteoProbe | Change from baseline at 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density (BMD) | Bone Mineral Density and T-score measured with Dual-Energy X-ray Absorptiometry (DXA) | Change from baseline at 9 months | 
| Procollagen Type 1 N-terminal propeptide (S-PINP) | Bone biomarker | Change from baseline at 3 and 9 months | 
| Serum C-telopeptide cross-link type 1 collagen (S-CTX) | Bone biomarker | Change from baseline at 3 and 9 months | 
| Sclerostin | Bone biomarker | Change from baseline at 3 and 9 months | 
| Bone alkaline phosphatase (S-BALP) | Bone biomarker | Change from baseline at 3 and 9 months | 
| Self-rated health questionnaire (SF-36) | A questionnaire with multiple choice questions about general health | Change from baseline at 9 months | 
| Falls Efficacy Scale (FES) | A questionnaire about self-efficacy and fear of falling, 1-10, where 0 equals not sure at all and 10 equals completely sure. Higher scores equals better outcome. | Change from baseline at 9 months | 
| Socialstyrelsens questionnaire for lifestyle habits | A questionnaire with multiple choice questions about falls and fractures, physical activity, sitting, alcohol and smoking | Change from baseline at 9 months | 
| Numerical Rating Scale (NRS) | A pain rating scale from 0-10, where 0 equals no pain and 10 equals maximum/worst possible pain imaginable. Higher scores equals worse outcome. | Change from baseline at 3 and 9 months | 
| Back extension strength | Measuring back extension strength with Digimax | Change from baseline at 9 months | 
| Grip strength | Measuring grip strength with hand dynamometer (JAMAR) | Change from baseline at 9 months | 
| Chair stand test | 5 seconds, 30 seconds and time for making 50 chair stands | Change from baseline at 9 months | 
| Back extension endurance | Measuring back extension endurance with Sörensen's test | Change from baseline at 9 months | 
| Static sit-up | Sitting with the upper body in 45 degrees | Change from baseline at 9 months | 
| Lung capacity | Lung capacity measured with dynamic spirometry (Welch Allyn) | Change from baseline at 9 months | 
| One leg standing (eyes open) | Balance test | Change from baseline at 9 months | 
| One leg standing (eyes closed) | Balance test | Change from baseline at 9 months | 
| Two leg standing on a straight line (eyes open) | Balance test | Change from baseline at 9 months | 
| Two leg standing on a straight line (eyes closed) | Balance test | Change from baseline at 9 months | 
| Walking forward on a straight line | Balance test | Change from baseline at 9 months | 
| Walking backwards between to lines | Balance test | Change from baseline at 9 months | 
| BtrackS | Balance test, measuring body sway, standing on a platform with both legs together, arms crossed and eyes closed. | Change from baseline at 9 months | 
| Accelerometry | Accelerometers worn around the waist to measure physical activity levels for up to nine days. | Change from baseline at 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, osteopenia, bone mineral density, bone density, physical activity, strength training, isometric training