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

Sponsor

Karolinska Institutet (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05721014

Collaborator

Region Stockholm (Other), The Swedish School of Sport and Health Sciences (Other), Linkoeping University (Other)

194

Enrollment

Location

Arms

25.9

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Osteopenia Bone Density, Low Bone Loss	Other: OsteoStrong Other: Individually Adapted and Combined Physical Training	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 4, 2021

Anticipated Primary Completion Date :

Jul 28, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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 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.
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 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.

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 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.

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 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.

Outcome Measures

Primary Outcome Measures

Bone Material Strength Index (BMSI) [Change from baseline at 9 months]
Bone Material Strength Index measured with impact microindentation using OsteoProbe

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 79 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care	Huddinge	Stockholms Län	Sweden	141 52