Bone Density, Low, Bone Loss, Osteopenia, Osteoporosis
Conditions
Keywords
osteoporosis, osteopenia, bone mineral density, bone density, physical activity, strength training, isometric training
Brief summary
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).
Interventions
OTHEROsteoStrong
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.
OTHERIndividually Adapted and Combined Physical Training
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.
Sponsors
Region Stockholm
The Swedish School of Sport and Health Sciences
Linkoeping University
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Material Strength Index (BMSI) | Change from baseline at 9 months | Bone Material Strength Index measured with impact microindentation using OsteoProbe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| One leg standing (eyes closed) | Change from baseline at 9 months | Balance test |
| Two leg standing on a straight line (eyes open) | Change from baseline at 9 months | Balance test |
| Static sit-up | Change from baseline at 9 months | Sitting with the upper body in 45 degrees |
| Lung capacity | Change from baseline at 9 months | Lung capacity measured with dynamic spirometry (Welch Allyn) |
| Bone Mineral Density (BMD) | Change from baseline at 9 months | Bone Mineral Density and T-score measured with Dual-Energy X-ray Absorptiometry (DXA) |
| Procollagen Type 1 N-terminal propeptide (S-PINP) | Change from baseline at 3 and 9 months | Bone biomarker |
| Serum C-telopeptide cross-link type 1 collagen (S-CTX) | Change from baseline at 3 and 9 months | Bone biomarker |
| Sclerostin | Change from baseline at 3 and 9 months | Bone biomarker |
| Bone alkaline phosphatase (S-BALP) | Change from baseline at 3 and 9 months | Bone biomarker |
| Self-rated health questionnaire (SF-36) | Change from baseline at 9 months | A questionnaire with multiple choice questions about general health |
| Falls Efficacy Scale (FES) | Change from baseline at 9 months | 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. |
| One leg standing (eyes open) | Change from baseline at 9 months | Balance test |
| Numerical Rating Scale (NRS) | Change from baseline at 3 and 9 months | 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. |
| Back extension strength | Change from baseline at 9 months | Measuring back extension strength with Digimax |
| Grip strength | Change from baseline at 9 months | Measuring grip strength with hand dynamometer (JAMAR) |
| Chair stand test | Change from baseline at 9 months | 5 seconds, 30 seconds and time for making 50 chair stands |
| Back extension endurance | Change from baseline at 9 months | Measuring back extension endurance with Sörensen's test |
| Two leg standing on a straight line (eyes closed) | Change from baseline at 9 months | Balance test |
| Walking forward on a straight line | Change from baseline at 9 months | Balance test |
| Walking backwards between to lines | Change from baseline at 9 months | Balance test |
| BtrackS | Change from baseline at 9 months | Balance test, measuring body sway, standing on a platform with both legs together, arms crossed and eyes closed. |
| Accelerometry | Change from baseline at 9 months | Accelerometers worn around the waist to measure physical activity levels for up to nine days. |
| Socialstyrelsens questionnaire for lifestyle habits | Change from baseline at 9 months | A questionnaire with multiple choice questions about falls and fractures, physical activity, sitting, alcohol and smoking |
Countries
Sweden
Outcome results
None listed