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

NCT ID: NCT05721014

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-04
• Study Completion Date: 2024-02-14

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).

Conditions

Osteoporosis; Osteopenia; Bone Density, Low; Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OsteoStrong

Training following the OsteoStrong-method.

Group Type: EXPERIMENTAL

OsteoStrong

Intervention Type: OTHER

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

Training based on current recommendations on exercise for people with osteoporosis.

Group Type: ACTIVE_COMPARATOR

Individually Adapted and Combined Physical Training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

The Swedish School of Sport and Health Sciences

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Helena Salminen

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helena Salminen, Ass. prof.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care

Huddinge, Stockholm County, Sweden

Countries

Sweden

Related Links

https://ki.se/nvs/den-benstarka-studien-kan-vi-med-traning-starka-vart-skelett

The website for the study.

Other Identifiers

2020-04359 Osteostrong

Identifier Type: -

Identifier Source: org_study_id