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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05721014
Other study ID # 2020-04359 Osteostrong
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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