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

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).

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Bone Loss; Osteopenia; Bone Density, Low
• Intervention / Treatment: Other: OsteoStrong; Other: Individually Adapted and Combined Physical Training

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholms Län
    • Huddinge, Stockholms Län, Sweden, 141 52
      • Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Material Strength Index (BMSI)	Bone Material Strength Index measured with impact microindentation using OsteoProbe	Change from baseline at 9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Linkoeping University; Region Stockholm; The Swedish School of Sport and Health Sciences
• Investigators: Principal Investigator: Helena Salminen, Ass. prof., Karolinska Institutet

Publications and helpful links

Helpful Links

• The website for the study.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): February 14, 2024

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; strength training; bone density; osteoporosis; osteopenia; bone mineral density; isometric training
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic
• Other Study ID Numbers: 2020-04359 Osteostrong

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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