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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05721014
• Other study ID #: 2020-04359 Osteostrong
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: February 14, 2024

Study information

• Verified date: April 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: February 14, 2024
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Density, Low
• Bone Diseases, Metabolic
• Bone Loss
• Osteopenia
• Osteoporosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care	Huddinge	Stockholms Län

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska Institutet	Linkoeping University, Region Stockholm, The Swedish School of Sport and Health Sciences

Country where clinical trial is conducted

Sweden, 

Outcome

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

External Links

•   The website for the study.