NCT05721014

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

Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health Amongst Older Women With High Fracture Risk: A Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: Female
• Age: 65 Years – 79 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-10-04
• Primary completion: 2023-07-12
• Completion: 2024-02-14
• First posted: 2023-02-09
• Last updated: 2024-04-10

Locations

1 site across 1 country: Sweden