NCT05721014CompletedNot Applicable
Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health Amongst Older Women With High Fracture Risk: A Randomised Controlled Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 194
- Locations
- 2
- Primary Endpoint
- Bone Material Strength Index (BMSI)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to 79 Years (Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Woman, 65-79 years old.
- •Vaccinated against Covid-
- •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.
Outcomes
Primary Outcomes
Bone Material Strength Index (BMSI)
Time Frame: Change from baseline at 9 months
Bone Material Strength Index measured with impact microindentation using OsteoProbe
Secondary Outcomes
- Sclerostin(Change from baseline at 3 and 9 months)
- Self-rated health questionnaire (SF-36)(Change from baseline at 9 months)
- Bone Mineral Density (BMD)(Change from baseline at 9 months)
- Grip strength(Change from baseline at 9 months)
- Static sit-up(Change from baseline at 9 months)
- Procollagen Type 1 N-terminal propeptide (S-PINP)(Change from baseline at 3 and 9 months)
- Chair stand test(Change from baseline at 9 months)
- Back extension endurance(Change from baseline at 9 months)
- Lung capacity(Change from baseline at 9 months)
- One leg standing (eyes closed)(Change from baseline at 9 months)
- Two leg standing on a straight line (eyes closed)(Change from baseline at 9 months)
- Walking forward on a straight line(Change from baseline at 9 months)
- Walking backwards between to lines(Change from baseline at 9 months)
- Back extension strength(Change from baseline at 9 months)
- Socialstyrelsens questionnaire for lifestyle habits(Change from baseline at 9 months)
- Numerical Rating Scale (NRS)(Change from baseline at 3 and 9 months)
- Two leg standing on a straight line (eyes open)(Change from baseline at 9 months)
- BtrackS(Change from baseline at 9 months)
- Accelerometry(Change from baseline at 9 months)
- Serum C-telopeptide cross-link type 1 collagen (S-CTX)(Change from baseline at 3 and 9 months)
- Bone alkaline phosphatase (S-BALP)(Change from baseline at 3 and 9 months)
- Falls Efficacy Scale (FES)(Change from baseline at 9 months)
- One leg standing (eyes open)(Change from baseline at 9 months)
Investigators
Helena Salminen
Associate professor
Karolinska Institutet
Study Sites (2)
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