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Completed

NCT Number: NCT05721014

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

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).

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Key information

Conditions

Osteoporosis Behavior Bone Density, Low Bone Diseases Bone Diseases, Metabolic Bone Loss Metabolic Diseases Motor Activity Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia

Age range

65 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Huddinge, Stockholm County, 141 52, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OsteoStrong

Other

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.

Individually Adapted and Combined Physical Training

Other

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Linkoeping University
  • Region Stockholm
  • The Swedish School of Sport and Health Sciences

Registry information

Official study title

Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health Amongst Older Women With High Fracture Risk: A Randomised Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 9, 2023
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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