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

• ClinicalTrials.gov Identifier: NCT05721014
• Recruitment Status: Completed
• First Posted: February 9, 2023
• Last Update Posted: April 10, 2024
• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm; The Swedish School of Sport and Health Sciences; Linkoeping University
• Information provided by (Responsible Party): Helena Salminen, Karolinska Institutet

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Osteoporosis; Osteopenia; Bone Density, Low; Bone Loss	Other: OsteoStrong; Other: Individually Adapted and Combined Physical Training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 194 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health Amongst Older Women With High Fracture Risk: A Randomised Controlled Trial
• Actual Study Start Date: October 4, 2021
• Actual Primary Completion Date: July 12, 2023
• Actual Study Completion Date: February 14, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: OsteoStrong; Training following the OsteoStrong-method.	Other: OsteoStrong; 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.
Active Comparator: Individually Adapted and Combined Physical Training; Training based on current recommendations on exercise for people with osteoporosis.	Other: Individually 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.

Outcome Measures

Primary Outcome Measures :

1. Bone Material Strength Index (BMSI) [ Time Frame: Change from baseline at 9 months ]
   Bone Material Strength Index measured with impact microindentation using OsteoProbe

Secondary Outcome Measures :

1. Bone Mineral Density (BMD) [ Time Frame: Change from baseline at 9 months ]
   Bone Mineral Density and T-score measured with Dual-Energy X-ray Absorptiometry (DXA)
2. Procollagen Type 1 N-terminal propeptide (S-PINP) [ Time Frame: Change from baseline at 3 and 9 months ]
   Bone biomarker
3. Serum C-telopeptide cross-link type 1 collagen (S-CTX) [ Time Frame: Change from baseline at 3 and 9 months ]
   Bone biomarker
4. Sclerostin [ Time Frame: Change from baseline at 3 and 9 months ]
   Bone biomarker
5. Bone alkaline phosphatase (S-BALP) [ Time Frame: Change from baseline at 3 and 9 months ]
   Bone biomarker
6. Self-rated health questionnaire (SF-36) [ Time Frame: Change from baseline at 9 months ]
   A questionnaire with multiple choice questions about general health
7. Falls Efficacy Scale (FES) [ Time Frame: 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.
8. Socialstyrelsens questionnaire for lifestyle habits [ Time Frame: Change from baseline at 9 months ]
   A questionnaire with multiple choice questions about falls and fractures, physical activity, sitting, alcohol and smoking
9. Numerical Rating Scale (NRS) [ Time Frame: 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.
10. Back extension strength [ Time Frame: Change from baseline at 9 months ]
    Measuring back extension strength with Digimax
11. Grip strength [ Time Frame: Change from baseline at 9 months ]
    Measuring grip strength with hand dynamometer (JAMAR)
12. Chair stand test [ Time Frame: Change from baseline at 9 months ]
    5 seconds, 30 seconds and time for making 50 chair stands
13. Back extension endurance [ Time Frame: Change from baseline at 9 months ]
    Measuring back extension endurance with Sörensen's test
14. Static sit-up [ Time Frame: Change from baseline at 9 months ]
    Sitting with the upper body in 45 degrees
15. Lung capacity [ Time Frame: Change from baseline at 9 months ]
    Lung capacity measured with dynamic spirometry (Welch Allyn)
16. One leg standing (eyes open) [ Time Frame: Change from baseline at 9 months ]
    Balance test
17. One leg standing (eyes closed) [ Time Frame: Change from baseline at 9 months ]
    Balance test
18. Two leg standing on a straight line (eyes open) [ Time Frame: Change from baseline at 9 months ]
    Balance test
19. Two leg standing on a straight line (eyes closed) [ Time Frame: Change from baseline at 9 months ]
    Balance test
20. Walking forward on a straight line [ Time Frame: Change from baseline at 9 months ]
    Balance test
21. Walking backwards between to lines [ Time Frame: Change from baseline at 9 months ]
    Balance test
22. BtrackS [ Time Frame: Change from baseline at 9 months ]
    Balance test, measuring body sway, standing on a platform with both legs together, arms crossed and eyes closed.
23. Accelerometry [ Time Frame: Change from baseline at 9 months ]
    Accelerometers worn around the waist to measure physical activity levels for up to nine days.

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 79 Years (Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Sweden

Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care

Huddinge, Stockholms Län, Sweden, 141 52

Sponsors and Collaborators

Karolinska Institutet

Region Stockholm

The Swedish School of Sport and Health Sciences

Linkoeping University

Investigators

• Principal Investigator: Helena Salminen, Ass. prof.; Karolinska Institutet

More Information

Additional Information:

The website for the study. 

• Responsible Party: Helena Salminen, Associate professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT05721014
• Other Study ID Numbers: 2020-04359 Osteostrong
• First Posted: February 9, 2023
• Last Update Posted: April 10, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Helena Salminen, Karolinska Institutet:

osteoporosis; osteopenia; bone mineral density; bone density; physical activity; strength training; isometric training

Additional relevant MeSH terms:

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases