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

NCT05721014 | Completed

• 1 other identifier: 2020-04359 Osteostrong
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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

Keywords

osteoporosis; osteopenia; bone mineral density; bone density; physical activity; strength training; isometric training

Outcome Measures

Primary Outcomes (1)

• Bone Material Strength Index (BMSI)

  Bone Material Strength Index measured with impact microindentation using OsteoProbe

  Change from baseline at 9 months

Secondary Outcomes (23)

• Bone Mineral Density (BMD)

  Change from baseline at 9 months

• Procollagen Type 1 N-terminal propeptide (S-PINP)

  Change from baseline at 3 and 9 months

• Serum C-telopeptide cross-link type 1 collagen (S-CTX)

  Change from baseline at 3 and 9 months

• Sclerostin

  Change from baseline at 3 and 9 months

• Bone alkaline phosphatase (S-BALP)

  Change from baseline at 3 and 9 months

Study Arms (2)

OsteoStrong

EXPERIMENTAL

Training following the OsteoStrong-method.

Other: OsteoStrong

Individually Adapted and Combined Physical Training

ACTIVE COMPARATOR

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

Other: Individually Adapted and Combined Physical Training

Interventions

OsteoStrong 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.

OsteoStrong

Individually Adapted and Combined Physical Training 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.

Individually Adapted and Combined Physical Training

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• The Swedish School of Sport and Health Sciences: collaborator
• Linkoeping University: collaborator

Study Sites (1)

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

Huddinge, Stockholm County, 141 52, Sweden

Location

Related Links

• The website for the study.

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Motor Activity

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Helena Salminen, Ass. prof.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 9, 2023
• Study Start: October 4, 2021
• Primary Completion: July 12, 2023
• Study Completion: February 14, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)