Clinical trial NCT05721014: Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Osteopenia
Bone Density, Low
Bone Loss
Keywords: osteoporosis
osteopenia
bone mineral density
bone density
physical activity
strength training
isometric training
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: The Swedish School of Sport and Health Sciences
name: Linkoeping University
First posted: 2023-02-09
Enrollment: 194
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Bone Material Strength Index (BMSI)
timeFrame: Change from baseline at 9 months
Secondary outcomes:
measure: Bone Mineral Density (BMD)
timeFrame: Change from baseline at 9 months
measure: Procollagen Type 1 N-terminal propeptide (S-PINP)
timeFrame: Change from baseline at 3 and 9 months
measure: Serum C-telopeptide cross-link type 1 collagen (S-CTX)
timeFrame: Change from baseline at 3 and 9 months
measure: Sclerostin
timeFrame: Change from baseline at 3 and 9 months
measure: Bone alkaline phosphatase (S-BALP)
timeFrame: Change from baseline at 3 and 9 months
measure: Self-rated health questionnaire (SF-36)
timeFrame: Change from baseline at 9 months
measure: Falls Efficacy Scale (FES)
timeFrame: Change from baseline at 9 months
measure: Socialstyrelsens questionnaire for lifestyle habits
timeFrame: Change from baseline at 9 months
measure: Numerical Rating Scale (NRS)
timeFrame: Change from baseline at 3 and 9 months
measure: Back extension strength
timeFrame: Change from baseline at 9 months
measure: Grip strength
timeFrame: Change from baseline at 9 months
measure: Chair stand test
timeFrame: Change from baseline at 9 months
measure: Back extension endurance
timeFrame: Change from baseline at 9 months
measure: Static sit-up
timeFrame: Change from baseline at 9 months
measure: Lung capacity
timeFrame: Change from baseline at 9 months
measure: One leg standing (eyes open)
timeFrame: Change from baseline at 9 months
measure: One leg standing (eyes closed)
timeFrame: Change from baseline at 9 months
measure: Two leg standing on a straight line (eyes open)
timeFrame: Change from baseline at 9 months
measure: Two leg standing on a straight line (eyes closed)
timeFrame: Change from baseline at 9 months
measure: Walking forward on a straight line
timeFrame: Change from baseline at 9 months
measure: Walking backwards between to lines
timeFrame: Change from baseline at 9 months
measure: BtrackS
timeFrame: Change from baseline at 9 months
measure: Accelerometry
timeFrame: Change from baseline at 9 months
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet - Department of Neurobiology, Care Sciences and Society: Division of Family medicine and Primary care
state: Stockholms Län
Study officials:
affiliation: Karolinska Institutet
name: Helena Salminen, Ass. prof.
role: PRINCIPAL_INVESTIGATOR
References: