Back to resultsEffects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health
Primary Purpose
Osteoporosis, Osteopenia, Bone Density, Low
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
OsteoStrong
Individually Adapted and Combined Physical Training
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, osteopenia, bone mineral density, bone density, physical activity, strength training, isometric training
Eligibility 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.
Sites / Locations
- Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OsteoStrong
Individually Adapted and Combined Physical Training
Arm Description
Training following the OsteoStrong-method.
Training based on current recommendations on exercise for people with osteoporosis.
Outcomes
Primary Outcome Measures
Bone Material Strength Index (BMSI)
Bone Material Strength Index measured with impact microindentation using OsteoProbe
Secondary Outcome Measures
Bone Mineral Density (BMD)
Bone Mineral Density and T-score measured with Dual-Energy X-ray Absorptiometry (DXA)
Procollagen Type 1 N-terminal propeptide (S-PINP)
Bone biomarker
Serum C-telopeptide cross-link type 1 collagen (S-CTX)
Bone biomarker
Sclerostin
Bone biomarker
Bone alkaline phosphatase (S-BALP)
Bone biomarker
Self-rated health questionnaire (SF-36)
A questionnaire with multiple choice questions about general health
Falls Efficacy Scale (FES)
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.
Socialstyrelsens questionnaire for lifestyle habits
A questionnaire with multiple choice questions about falls and fractures, physical activity, sitting, alcohol and smoking
Numerical Rating Scale (NRS)
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.
Back extension strength
Measuring back extension strength with Digimax
Grip strength
Measuring grip strength with hand dynamometer (JAMAR)
Chair stand test
5 seconds, 30 seconds and time for making 50 chair stands
Back extension endurance
Measuring back extension endurance with Sörensen's test
Static sit-up
Sitting with the upper body in 45 degrees
Lung capacity
Lung capacity measured with dynamic spirometry (Welch Allyn)
One leg standing (eyes open)
Balance test
One leg standing (eyes closed)
Balance test
Two leg standing on a straight line (eyes open)
Balance test
Two leg standing on a straight line (eyes closed)
Balance test
Walking forward on a straight line
Balance test
Walking backwards between to lines
Balance test
BtrackS
Balance test, measuring body sway, standing on a platform with both legs together, arms crossed and eyes closed.
Full Information
NCT ID
NCT05721014
First Posted
January 20, 2023
Last Updated
January 31, 2023
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, The Swedish School of Sport and Health Sciences, Linkoeping University
1. Study Identification
Unique Protocol Identification Number
NCT05721014
Brief Title
Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
July 28, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, The Swedish School of Sport and Health Sciences, Linkoeping University
4. Oversight
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
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia, Bone Density, Low, Bone Loss
Keywords
osteoporosis, osteopenia, bone mineral density, bone density, physical activity, strength training, isometric training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OsteoStrong
Arm Type
Experimental
Arm Description
Training following the OsteoStrong-method.
Arm Title
Individually Adapted and Combined Physical Training
Arm Type
Active Comparator
Arm Description
Training based on current recommendations on exercise for people with osteoporosis.
Intervention Type
Other
Intervention Name(s)
OsteoStrong
Intervention Description
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 30 seconds once on every machine.
The training session takes around 20 minutes and is performed individually by the participants with the help of a training instructor.
Intervention Type
Other
Intervention Name(s)
Individually Adapted and Combined Physical Training
Intervention Description
This training method is based on the current recommendations on physical activity for people with osteoporosis. The training is individually adapted strength training combined with balance and weight-bearing exercises.
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.
Primary Outcome Measure Information:
Title
Bone Material Strength Index (BMSI)
Description
Bone Material Strength Index measured with impact microindentation using OsteoProbe
Time Frame
Change from baseline at 9 months
Secondary Outcome Measure Information:
Title
Bone Mineral Density (BMD)
Description
Bone Mineral Density and T-score measured with Dual-Energy X-ray Absorptiometry (DXA)
Time Frame
Change from baseline at 9 months
Title
Procollagen Type 1 N-terminal propeptide (S-PINP)
Description
Bone biomarker
Time Frame
Change from baseline at 3 and 9 months
Title
Serum C-telopeptide cross-link type 1 collagen (S-CTX)
Description
Bone biomarker
Time Frame
Change from baseline at 3 and 9 months
Title
Sclerostin
Description
Bone biomarker
Time Frame
Change from baseline at 3 and 9 months
Title
Bone alkaline phosphatase (S-BALP)
Description
Bone biomarker
Time Frame
Change from baseline at 3 and 9 months
Title
Self-rated health questionnaire (SF-36)
Description
A questionnaire with multiple choice questions about general health
Time Frame
Change from baseline at 9 months
Title
Falls Efficacy Scale (FES)
Description
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.
Time Frame
Change from baseline at 9 months
Title
Socialstyrelsens questionnaire for lifestyle habits
Description
A questionnaire with multiple choice questions about falls and fractures, physical activity, sitting, alcohol and smoking
Time Frame
Change from baseline at 9 months
Title
Numerical Rating Scale (NRS)
Description
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.
Time Frame
Change from baseline at 3 and 9 months
Title
Back extension strength
Description
Measuring back extension strength with Digimax
Time Frame
Change from baseline at 9 months
Title
Grip strength
Description
Measuring grip strength with hand dynamometer (JAMAR)
Time Frame
Change from baseline at 9 months
Title
Chair stand test
Description
5 seconds, 30 seconds and time for making 50 chair stands
Time Frame
Change from baseline at 9 months
Title
Back extension endurance
Description
Measuring back extension endurance with Sörensen's test
Time Frame
Change from baseline at 9 months
Title
Static sit-up
Description
Sitting with the upper body in 45 degrees
Time Frame
Change from baseline at 9 months
Title
Lung capacity
Description
Lung capacity measured with dynamic spirometry (Welch Allyn)
Time Frame
Change from baseline at 9 months
Title
One leg standing (eyes open)
Description
Balance test
Time Frame
Change from baseline at 9 months
Title
One leg standing (eyes closed)
Description
Balance test
Time Frame
Change from baseline at 9 months
Title
Two leg standing on a straight line (eyes open)
Description
Balance test
Time Frame
Change from baseline at 9 months
Title
Two leg standing on a straight line (eyes closed)
Description
Balance test
Time Frame
Change from baseline at 9 months
Title
Walking forward on a straight line
Description
Balance test
Time Frame
Change from baseline at 9 months
Title
Walking backwards between to lines
Description
Balance test
Time Frame
Change from baseline at 9 months
Title
BtrackS
Description
Balance test, measuring body sway, standing on a platform with both legs together, arms crossed and eyes closed.
Time Frame
Change from baseline at 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Salminen, Ass. prof.
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care
City
Huddinge
State/Province
Stockholms Län
ZIP/Postal Code
141 52
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://ki.se/nvs/den-benstarka-studien-kan-vi-med-traning-starka-vart-skelett
Description
The website for the study.
Learn more about this trial
Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health
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