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

• ClinicalTrials.gov Identifier: NCT05721014
• Recruitment Status: Completed
• First Posted: February 9, 2023
• Last Update Posted: April 10, 2024
• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm; The Swedish School of Sport and Health Sciences; Linkoeping University
• Information provided by (Responsible Party): Helena Salminen, Karolinska Institutet

Tracking Information

• First Submitted Date: January 20, 2023
• First Posted Date: February 9, 2023
• Last Update Posted Date: April 10, 2024
• Actual Study Start Date: October 4, 2021
• Actual Primary Completion Date: July 12, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 31, 2023)

Bone Material Strength Index (BMSI) [ Time Frame: Change from baseline at 9 months ]

Bone Material Strength Index measured with impact microindentation using OsteoProbe

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 12, 2023)

• Bone Mineral Density (BMD) [ Time Frame: Change from baseline at 9 months ]
  Bone Mineral Density and T-score measured with Dual-Energy X-ray Absorptiometry (DXA)
• Procollagen Type 1 N-terminal propeptide (S-PINP) [ Time Frame: Change from baseline at 3 and 9 months ]
  Bone biomarker
• Serum C-telopeptide cross-link type 1 collagen (S-CTX) [ Time Frame: Change from baseline at 3 and 9 months ]
  Bone biomarker
• Sclerostin [ Time Frame: Change from baseline at 3 and 9 months ]
  Bone biomarker
• Bone alkaline phosphatase (S-BALP) [ Time Frame: Change from baseline at 3 and 9 months ]
  Bone biomarker
• Self-rated health questionnaire (SF-36) [ Time Frame: Change from baseline at 9 months ]
  A questionnaire with multiple choice questions about general health
• Falls Efficacy Scale (FES) [ Time Frame: Change from baseline at 9 months ]
  A questionnaire about self-efficacy and fear of falling, 1-10, where 0 equals "not sure at all" and 10 equals "completely sure". Higher scores equals better outcome.
• Socialstyrelsens questionnaire for lifestyle habits [ Time Frame: Change from baseline at 9 months ]
  A questionnaire with multiple choice questions about falls and fractures, physical activity, sitting, alcohol and smoking
• Numerical Rating Scale (NRS) [ Time Frame: Change from baseline at 3 and 9 months ]
  A pain rating scale from 0-10, where 0 equals "no pain" and 10 equals "maximum/worst possible pain imaginable". Higher scores equals worse outcome.
• Back extension strength [ Time Frame: Change from baseline at 9 months ]
  Measuring back extension strength with Digimax
• Grip strength [ Time Frame: Change from baseline at 9 months ]
  Measuring grip strength with hand dynamometer (JAMAR)
• Chair stand test [ Time Frame: Change from baseline at 9 months ]
  5 seconds, 30 seconds and time for making 50 chair stands
• Back extension endurance [ Time Frame: Change from baseline at 9 months ]
  Measuring back extension endurance with Sörensen's test
• Static sit-up [ Time Frame: Change from baseline at 9 months ]
  Sitting with the upper body in 45 degrees
• Lung capacity [ Time Frame: Change from baseline at 9 months ]
  Lung capacity measured with dynamic spirometry (Welch Allyn)
• One leg standing (eyes open) [ Time Frame: Change from baseline at 9 months ]
  Balance test
• One leg standing (eyes closed) [ Time Frame: Change from baseline at 9 months ]
  Balance test
• Two leg standing on a straight line (eyes open) [ Time Frame: Change from baseline at 9 months ]
  Balance test
• Two leg standing on a straight line (eyes closed) [ Time Frame: Change from baseline at 9 months ]
  Balance test
• Walking forward on a straight line [ Time Frame: Change from baseline at 9 months ]
  Balance test
• Walking backwards between to lines [ Time Frame: Change from baseline at 9 months ]
  Balance test
• BtrackS [ Time Frame: Change from baseline at 9 months ]
  Balance test, measuring body sway, standing on a platform with both legs together, arms crossed and eyes closed.
• Accelerometry [ Time Frame: Change from baseline at 9 months ]
  Accelerometers worn around the waist to measure physical activity levels for up to nine days.

Original Secondary Outcome Measures (submitted: January 31, 2023)

• Bone Mineral Density (BMD) [ Time Frame: Change from baseline at 9 months ]
  Bone Mineral Density and T-score measured with Dual-Energy X-ray Absorptiometry (DXA)
• Procollagen Type 1 N-terminal propeptide (S-PINP) [ Time Frame: Change from baseline at 3 and 9 months ]
  Bone biomarker
• Serum C-telopeptide cross-link type 1 collagen (S-CTX) [ Time Frame: Change from baseline at 3 and 9 months ]
  Bone biomarker
• Sclerostin [ Time Frame: Change from baseline at 3 and 9 months ]
  Bone biomarker
• Bone alkaline phosphatase (S-BALP) [ Time Frame: Change from baseline at 3 and 9 months ]
  Bone biomarker
• Self-rated health questionnaire (SF-36) [ Time Frame: Change from baseline at 9 months ]
  A questionnaire with multiple choice questions about general health
• Falls Efficacy Scale (FES) [ Time Frame: Change from baseline at 9 months ]
  A questionnaire about self-efficacy and fear of falling, 1-10, where 0 equals "not sure at all" and 10 equals "completely sure". Higher scores equals better outcome.
• Socialstyrelsens questionnaire for lifestyle habits [ Time Frame: Change from baseline at 9 months ]
  A questionnaire with multiple choice questions about falls and fractures, physical activity, sitting, alcohol and smoking
• Numerical Rating Scale (NRS) [ Time Frame: Change from baseline at 3 and 9 months ]
  A pain rating scale from 0-10, where 0 equals "no pain" and 10 equals "maximum/worst possible pain imaginable". Higher scores equals worse outcome.
• Back extension strength [ Time Frame: Change from baseline at 9 months ]
  Measuring back extension strength with Digimax
• Grip strength [ Time Frame: Change from baseline at 9 months ]
  Measuring grip strength with hand dynamometer (JAMAR)
• Chair stand test [ Time Frame: Change from baseline at 9 months ]
  5 seconds, 30 seconds and time for making 50 chair stands
• Back extension endurance [ Time Frame: Change from baseline at 9 months ]
  Measuring back extension endurance with Sörensen's test
• Static sit-up [ Time Frame: Change from baseline at 9 months ]
  Sitting with the upper body in 45 degrees
• Lung capacity [ Time Frame: Change from baseline at 9 months ]
  Lung capacity measured with dynamic spirometry (Welch Allyn)
• One leg standing (eyes open) [ Time Frame: Change from baseline at 9 months ]
  Balance test
• One leg standing (eyes closed) [ Time Frame: Change from baseline at 9 months ]
  Balance test
• Two leg standing on a straight line (eyes open) [ Time Frame: Change from baseline at 9 months ]
  Balance test
• Two leg standing on a straight line (eyes closed) [ Time Frame: Change from baseline at 9 months ]
  Balance test
• Walking forward on a straight line [ Time Frame: Change from baseline at 9 months ]
  Balance test
• Walking backwards between to lines [ Time Frame: Change from baseline at 9 months ]
  Balance test
• BtrackS [ Time Frame: Change from baseline at 9 months ]
  Balance test, measuring body sway, standing on a platform with both legs together, arms crossed and eyes closed.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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).

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Osteoporosis
• Osteopenia
• Bone Density, Low
• Bone Loss

Intervention

• 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.

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 31, 2023): 194
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 14, 2024
• Actual Primary Completion Date: July 12, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 65 Years to 79 Years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT05721014
• Other Study ID Numbers: 2020-04359 Osteostrong
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Helena Salminen, Karolinska Institutet
• Original Responsible Party: Same as current
• Current Study Sponsor: Karolinska Institutet
• Original Study Sponsor: Same as current

Collaborators

• Region Stockholm
• The Swedish School of Sport and Health Sciences
• Linkoeping University

Investigators

• Principal Investigator: Helena Salminen, Ass. prof.; Karolinska Institutet

• PRS Account: Karolinska Institutet
• Verification Date: April 2024