NCT05721014Completed
Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health
Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health Amongst Older Women With High Fracture Risk: A Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 10 Apr 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 194 (actual)
- First submitted
- 20 Jan 2023
- Start date
- 4 Oct 2021
- Primary completion date
- 12 Jul 2023
- Lead sponsor
- Karolinska Institutet
- Diseases
- Osteoporosis
- NCT number
- NCT05721014
What you commit to
- Study type: Interventional
- Participants enrolled: 194
- From 4 Oct 2021 to the primary completion date, 12 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 or hip fracture, that have not previously been treated with Osteoporosis-medications or been assessed by a physician.
- Ongoing treatment with oral cortisone pills (≥ 5 mg Prednisolone).
- Ongoing or previous training (within the last year) at OsteoStrong.
Other illness
- 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.
- Conditions that hinders the conduction of impact microindentation with OsteoProbe: large edema, skin infection, allergy towards local anaesthetics.
Other
- Vertebral fracture, that have been diagnosed within three months.
- Bilateral hip replacements.
- Symptomatic disc herniation, inguinal herniation or umbilical herniation.
Who the study is looking for
- 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.
Age in the registry: 65 years to 79 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care Coordinator of this site? Confirm its status | Huddinge | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.