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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
194
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.
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.
Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care
Huddinge, Stockholm County, Sweden
Bone Material Strength Index (BMSI)
Bone Material Strength Index measured with impact microindentation using OsteoProbe
Time frame: Change from baseline at 9 months
Bone Mineral Density (BMD)
Bone Mineral Density and T-score measured with Dual-Energy X-ray Absorptiometry (DXA)
Time frame: Change from baseline at 9 months
Procollagen Type 1 N-terminal propeptide (S-PINP)
Bone biomarker
Time frame: Change from baseline at 3 and 9 months
Serum C-telopeptide cross-link type 1 collagen (S-CTX)
Bone biomarker
Time frame: Change from baseline at 3 and 9 months
Sclerostin
Bone biomarker
Time frame: Change from baseline at 3 and 9 months
Bone alkaline phosphatase (S-BALP)
Bone biomarker
Time frame: Change from baseline at 3 and 9 months
Self-rated health questionnaire (SF-36)
A questionnaire with multiple choice questions about general health
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Change from baseline at 3 and 9 months
Back extension strength
Measuring back extension strength with Digimax
Time frame: Change from baseline at 9 months
Grip strength
Measuring grip strength with hand dynamometer (JAMAR)
Time frame: Change from baseline at 9 months
Chair stand test
5 seconds, 30 seconds and time for making 50 chair stands
Time frame: Change from baseline at 9 months
Back extension endurance
Measuring back extension endurance with Sörensen's test
Time frame: Change from baseline at 9 months
Static sit-up
Sitting with the upper body in 45 degrees
Time frame: Change from baseline at 9 months
Lung capacity
Lung capacity measured with dynamic spirometry (Welch Allyn)
Time frame: Change from baseline at 9 months
One leg standing (eyes open)
Balance test
Time frame: Change from baseline at 9 months
One leg standing (eyes closed)
Balance test
Time frame: Change from baseline at 9 months
Two leg standing on a straight line (eyes open)
Balance test
Time frame: Change from baseline at 9 months
Two leg standing on a straight line (eyes closed)
Balance test
Time frame: Change from baseline at 9 months
Walking forward on a straight line
Balance test
Time frame: Change from baseline at 9 months
Walking backwards between to lines
Balance test
Time frame: 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.
Time frame: Change from baseline at 9 months
Accelerometry
Accelerometers worn around the waist to measure physical activity levels for up to nine days.
Time frame: Change from baseline at 9 months
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