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

Not Applicable

Completed

• Conditions: Bone Density, Low; Osteoporosis; Osteopenia; Bone Loss
• Interventions: Other: Individually Adapted and Combined Physical Training; Other: OsteoStrong

• Registration Number: NCT05721014
• Lead Sponsor: Karolinska Institutet

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-04
• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-09
• Primary Completion: 2023-07-12
• Study Completion: 2024-02-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 194

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individually Adapted and Combined Physical Training	Individually Adapted and Combined Physical Training	Training based on current recommendations on exercise for people with osteoporosis.
OsteoStrong	OsteoStrong	Training following the OsteoStrong-method.

Primary Outcome Measures

Name	Time	Method
Bone Material Strength Index (BMSI)	Change from baseline at 9 months	Bone Material Strength Index measured with impact microindentation using OsteoProbe

Secondary Outcome Measures

Name	Time	Method
Walking backwards between to lines	Change from baseline at 9 months	Balance test
Sclerostin	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
Bone Mineral Density (BMD)	Change from baseline at 9 months	Bone Mineral Density and T-score measured with Dual-Energy X-ray Absorptiometry (DXA)
Grip strength	Change from baseline at 9 months	Measuring grip strength with hand dynamometer (JAMAR)
Static sit-up	Change from baseline at 9 months	Sitting with the upper body in 45 degrees
Procollagen Type 1 N-terminal propeptide (S-PINP)	Change from baseline at 3 and 9 months	Bone biomarker
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
Lung capacity	Change from baseline at 9 months	Lung capacity measured with dynamic spirometry (Welch Allyn)
One leg standing (eyes closed)	Change from baseline at 9 months	Balance 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
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
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.
Two leg standing on a straight line (eyes open)	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.
Serum C-telopeptide cross-link type 1 collagen (S-CTX)	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
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.
Back extension strength	Change from baseline at 9 months	Measuring back extension strength with Digimax
One leg standing (eyes open)	Change from baseline at 9 months	Balance test

Trial Locations

Locations (1)

Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care; 🇸🇪 Huddinge, Stockholms Län, Sweden