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

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Karolinska Institute

Status

Completed

Conditions

Osteopenia
Osteoporosis
Bone Density, Low
Bone Loss

Treatments

Other: OsteoStrong
Other: Individually Adapted and Combined Physical Training

Study type

Interventional

Funder types

Other

Identifiers

NCT05721014
2020-04359 Osteostrong

Details and patient eligibility

About

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).

Enrollment

194 patients

Sex

Female

Ages

65 to 79 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

194 participants in 2 patient groups

OsteoStrong
Experimental group
Description:
Training following the OsteoStrong-method.
Treatment:
Other: OsteoStrong
Individually Adapted and Combined Physical Training
Active Comparator group
Description:
Training based on current recommendations on exercise for people with osteoporosis.
Treatment:
Other: Individually Adapted and Combined Physical Training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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