OsteoporosisNCT05227976
Patient Education With or Without Physical Training or Mindfulness and Medical Yoga in Established Spinal Osteoporosis
A study testing Patient education (Theory), Physical training and Mindfulness and medical yoga in group in people with Osteoporosis and Vertebral Fracture, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
In the present feasibility and pilot study we aim to investigate the effect and safety of patient education with or without additional physical training or mindfulness/medical yoga in patients with manifest spinal osteoporosis (at least one vertebral fracture). Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Osteoporosis, Vertebral Fracture
- What is being tested?
- Patient education (Theory), Physical training and Mindfulness and medical yoga in group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSweden
- Study dates
- 15 Mar 2018to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with established spinal osteoporosis (at least one vertebral fracture and osteoporosis)
- >3 months had passed since the most recent VF
- age ≥60 years
- physical ability to walk without an indoor walker
Who cannot join
- inability to understand the Swedish language or difficulty following the research protocol or dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short- and Long-term Effects of Patient Education With or Without Physical Training or Mindfulness and Medical Yoga in Patients With Established Spinal Osteoporosis
In the present feasibility and pilot study we aim to investigate the effect and safety of patient education with or without additional physical training or mindfulness/medical yoga in patients with manifest spinal osteoporosis (at least one vertebral fracture).
The study includes a 10-week intervention period with once weekly theory education with or without additional physical training or mindfulness/medical yoga (randomized groups). Furthermore, a proceeding observation period of 10 weeks as well as a 1-year follow up post-intervention observation are included in the study design.
Read the detailed description
The SOL-study (School of Osteoporosis in Linköping) is a feasibility and pilot study on patient education in manifest spinal osteoporosis. The study design is interventional with patients randomized to one of three different interventions, i.e.
- Theory only (T group)
- Theory and physical exercise (TPh-group)
- Theory and mindfulness/medical yoga (TMMY-group)
The intervention period is 10 weeks, including 1 hour theory session/week (same for all groups) and for TPh- and TMMY-groups a one hour group training session is scheduled before the theory session.
Inclusion criteria are: 1) manifest spinal osteoporosis (diagnosed osteoporosis and > 1 vertebral fracture [VF]); 2) > 3 months had passed since the most recent VF; and 3) age over 60 years.
Clinical testing and questionnaire evaluation are performed at three timepoints; 1) Baseline (T1), i.e. before intervention; 2) Post-observation (T2) i.e. after a passive observation time of 4 months); and 3) Post-intervention (T3) i.e. after the interventions. A one year follow up post-intervention is performed by questionnaire evaluation.
- Conditions
- Osteoporosis, Vertebral Fracture
- Being tested
- Patient education (Theory), Physical training, Mindfulness and medical yoga in group
- Keywords
- patient education, yoga, mindfulness, physical training
- Medical subject headings
- Osteoporosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education (Theory)Behavioural
Theory/Lectures (1h/week)
Interventions given once weekly for 10 weeks.
Physical trainingBehavioural
Physical training group (1 hour/week)
Interventions given once weekly for 10 weeks.
Mindfulness and medical yoga in groupBehavioural
Mindfulness/medical yoga in group (1hour/week)
Interventions given once weekly for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Theory only | Active comparator | Once weekly for 10 weeks Receives: Behavioral: Patient education (Theory) |
| Theory and physical training | Active comparator | Once weekly for 10 weeks Receives: Behavioral: Patient education (Theory); Behavioral: Physical training |
| Theory and mindfulness/medical yoga | Active comparator | Once weekly for 10 weeks Receives: Behavioral: Patient education (Theory); Behavioral: Mindfulness and medical yoga in group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (HRQoL) - disease specific
Assessed with Qualeffo-41 (quality of life questionnaire of the European foundation for osteoporosis). The Qualeffo-41 includes 41 questions in seven domains. Domain scores are calculated by averaging the scores of one domain, and transforming them into a 0-100 scale according to a manual on scoring algorithm. Zero indicates the best possible and 100 the worst HRQoL. The Total Qualeffo-41 score is calculated by summing the answers of all questions and transforming the raw total scores from 0-100 (IOF homepage 2007 http://www.iofbonehealth.org)
Measured: 1.5 year
Health-related quality of life (HRQoL) - generic
Assessed with RAND-36 (Research and Development questionnaire). The RAND-36 compromises 36 items with two to six response options according to an ordinal scale. Eight health domains are assessed, coded, scored and summarised to derive the domains. The scores are transformed into a 0-100 scale. Zero indicates the worst possible HRQoL and 100 the best.
Measured: 1.5 year
Body weight
Body weight (kg) is measured by a digital scale, and with the participant in an upright position without shoes.
Measured: 6 months
Body height
Body height (cm) is measured by a stadiometer with the participant in an upright position without shoes.
Measured: 6 months
Static balance test
The static balance tests are performed without shoes both with the eyes open and with the eyes closed. (The floor is leveled, and the room is well illuminated). The static balance tests are limited to a maximum of 30 seconds and timed by using a stop-watch. The one-leg stance tests are performed with the opposite foot lifted halfway upon the calf of the supported leg and the arms at a vertical position at the sides of the body. If the participant has contact with the floor with the non-standing foot the time is stopped. The one-leg standing time (on each leg) tests are performed three times and the best of the trials is used as the final score
Measured: 6 months
Dynamic balance test
Dynamic balance tests are walking without shoes forwards heel to toe on a line and walking backwards toe to heel on a line. These tests are performed three times and the number of correct steps is counted and maximized to 15 correct steps, where the best of the trials is used as the final score.
Measured: 6 months
Muscle strength Chair-stand
The chair-stand test is performed from sitting on a stable chair with the arms crossed in front of the chest. The total number of risings is counted for 30 seconds using a stop-watch.
Measured: 6 months
Muscle strength Hand grip
Hand grip strength is measured in kilograms by using the Jamar dynamometer both of the dominant and the non-dominant hand. The subject is sitting on a stable chair with 90° of the elbow and support for the forearm in a neutral position, but with no support for the hand which is gripping the dynamometer. The adjustable handle was set at the second handle position for standardization. Each test was performed three times and the best trial was used as the final score.
Measured: 6 months
C7 to wall distance
The participant stans upright, as tall as possible, with both heels and the back against the wall and the head in a neutral position. A folding ruler is used to measure the perpendicular distance in centimeter between the seventh cervical vertebra (C7) and the wall.
Measured: 6 months
Pain assessment
Numeric rating scale (NRS) is used to measure present pain intensity, pain for the last week and worst pain. The participant is asked to report an integer between 0-10 to assess the perceived pain, where "no pain" is rated as 0 and "worst possible pain" is rated as 10.
Measured: 1.5 year
Number of patients using pain medications regularly
Participants are asked for their usage of pain medications (i.e. names of the drugs).
Measured: 1.5 year
Physical activity
Two physical activity questions are used and answered by categories on a six-point (question 1) and seven-point Likert scale (question 2), respectively:
- First question: During a regular week, how much time do you spend exercising on a level that makes you short winded, for example running, fitness class or ball games? Possible answers: 0 minutes, <30 minutes, 30-60 minutes, 60-90 minutes, 90-120 minutes, >120 minutes (
- Second question: During a regular week, how much time are you physically active in ways that are not exercise, for example walks, bicycling or gardening? Add together all activities lasting at least 10 minutes. Possible answers: 0 minutes, <30 minutes, 30-60 minutes, 60-90 minutes, 90-150 minutes, 150-300 minutes, >300 minutes
Measured: 1.5 year
Patient enablement instrument (PEI)
The patient enablement instrument (PEI) is used to measure the patient's perceived change in ability to understand and cope with his or her health issues after the treatment period and contains six items. The text "As a result of the participating in the Osteoporosis School, do you feel that you are …" is followed by six items; 1) able to cope with life, 2) able to understand your illness, 3) able to cope with your illness, 4) able to keep yourself healthy, 5) confident about your health, and 6) able to help yourself. The following five alternative answers were used for each statement; much better/much more, better/more, same, less/worse and not applicable. The PEI point for much better/much more is 2; for better/more is 1; and for same, less/worse or not applicable is 0. These points are added and thus the total PEI score ranges between 0 (worst score) and 12 (best score).
Measured: 1.5 year
Subjective experience of the patient education
The participants' overall experiences of the theoretical lectures (and the physical training) are scored on a six-level Likert scale (scores 0-6), where 5 is considered very satisfied and 0 is not at all satisfied.
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start15 Mar 2018
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Spangeus, University Hospital, Linkoeping
- Investigators
- Anna Spångeus, Ass.Prof, MD, Principal investigator, Univerity Hospital Linköping, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227976
- Sponsor's protocol ID
- SOL-study
- Status last verified
- May 2023
- First submitted
- 12 Jan 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Long-term Effects of Patient Education With or Without Physical Training or Mindfulness and Medical Yoga in Patients With Established Spinal Osteoporosis
- ClinicalTrials.gov ID
- NCT05227976
- Acronym / sponsor ID
- SOL-study
- Conditions
- Osteoporosis, Vertebral Fracture
- Keywords
- patient education, yoga, mindfulness, physical training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the present feasibility and pilot study we aim to investigate the effect and safety of patient education with or without additional physical training or mindfulness/medical yoga in patients with manifest spinal osteoporosis (at least one vertebral fracture).
The study includes a 10-week intervention period with once weekly theory education with or without additional physical training or mindfulness/medical yoga (randomized groups). Furthermore, a proceeding observation period of 10 weeks as well as a 1-year follow up post-intervention observation are included in the study design.
Detailed description
The SOL-study (School of Osteoporosis in Linköping) is a feasibility and pilot study on patient education in manifest spinal osteoporosis. The study design is interventional with patients randomized to one of three different interventions, i.e.
- Theory only (T group)
- Theory and physical exercise (TPh-group)
- Theory and mindfulness/medical yoga (TMMY-group)
The intervention period is 10 weeks, including 1 hour theory session/week (same for all groups) and for TPh- and TMMY-groups a one hour group training session is scheduled before the theory session.
Inclusion criteria are: 1) manifest spinal osteoporosis (diagnosed osteoporosis and > 1 vertebral fracture [VF]); 2) > 3 months had passed since the most recent VF; and 3) age over 60 years.
Clinical testing and questionnaire evaluation are performed at three timepoints; 1) Baseline (T1), i.e. before intervention; 2) Post-observation (T2) i.e. after a passive observation time of 4 months); and 3) Post-intervention (T3) i.e. after the interventions. A one year follow up post-intervention is performed by questionnaire evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Theory only | Active comparator | Behavioral: Patient education (Theory)Once weekly for 10 weeks |
| Theory and physical training | Active comparator | Behavioral: Patient education (Theory), Behavioral: Physical trainingOnce weekly for 10 weeks |
| Theory and mindfulness/medical yoga | Active comparator | Behavioral: Patient education (Theory), Behavioral: Mindfulness and medical yoga in groupOnce weekly for 10 weeks |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with established spinal osteoporosis (at least one vertebral fracture and osteoporosis)
- >3 months had passed since the most recent VF
- age ≥60 years
- physical ability to walk without an indoor walker
Key exclusion criteria (1 listed)
- inability to understand the Swedish language or difficulty following the research protocol or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient education (Theory)Theory/Lectures (1h/week) Interventions given once weekly for 10 weeks. | Behavioural | Theory and mindfulness/medical yoga, Theory and physical training, Theory only |
| Physical trainingPhysical training group (1 hour/week) Interventions given once weekly for 10 weeks. | Behavioural | Theory and physical training |
| Mindfulness and medical yoga in groupMindfulness/medical yoga in group (1hour/week) Interventions given once weekly for 10 weeks. | Behavioural | Theory and mindfulness/medical yoga |
Primary outcome
Health-related quality of life (HRQoL) - disease specific
Time frame: 1.5 year
Assessed with Qualeffo-41 (quality of life questionnaire of the European foundation for osteoporosis). The Qualeffo-41 includes 41 questions in seven domains. Domain scores are calculated by averaging the scores of one domain, and transforming them into a 0-100 scale according to a manual on scoring algorithm. Zero indicates the best possible and 100 the worst HRQoL. The Total Qualeffo-41 score is calculated by summing the answers of all questions and transforming the raw total scores from 0-100 (IOF homepage 2007 http://www.iofbonehealth.org)
Health-related quality of life (HRQoL) - generic
Time frame: 1.5 year
Assessed with RAND-36 (Research and Development questionnaire). The RAND-36 compromises 36 items with two to six response options according to an ordinal scale. Eight health domains are assessed, coded, scored and summarised to derive the domains. The scores are transformed into a 0-100 scale. Zero indicates the worst possible HRQoL and 100 the best.
Body weight
Time frame: 6 months
Body weight (kg) is measured by a digital scale, and with the participant in an upright position without shoes.
Body height
Time frame: 6 months
Body height (cm) is measured by a stadiometer with the participant in an upright position without shoes.
Static balance test
Time frame: 6 months
The static balance tests are performed without shoes both with the eyes open and with the eyes closed. (The floor is leveled, and the room is well illuminated). The static balance tests are limited to a maximum of 30 seconds and timed by using a stop-watch. The one-leg stance tests are performed with the opposite foot lifted halfway upon the calf of the supported leg and the arms at a vertical position at the sides of the body. If the participant has contact with the floor with the non-standing foot the time is stopped. The one-leg standing time (on each leg) tests are performed three times and the best of the trials is used as the final score
Dynamic balance test
Time frame: 6 months
Dynamic balance tests are walking without shoes forwards heel to toe on a line and walking backwards toe to heel on a line. These tests are performed three times and the number of correct steps is counted and maximized to 15 correct steps, where the best of the trials is used as the final score.
Muscle strength Chair-stand
Time frame: 6 months
The chair-stand test is performed from sitting on a stable chair with the arms crossed in front of the chest. The total number of risings is counted for 30 seconds using a stop-watch.
Muscle strength Hand grip
Time frame: 6 months
Hand grip strength is measured in kilograms by using the Jamar dynamometer both of the dominant and the non-dominant hand. The subject is sitting on a stable chair with 90° of the elbow and support for the forearm in a neutral position, but with no support for the hand which is gripping the dynamometer. The adjustable handle was set at the second handle position for standardization. Each test was performed three times and the best trial was used as the final score.
C7 to wall distance
Time frame: 6 months
The participant stans upright, as tall as possible, with both heels and the back against the wall and the head in a neutral position. A folding ruler is used to measure the perpendicular distance in centimeter between the seventh cervical vertebra (C7) and the wall.
Pain assessment
Time frame: 1.5 year
Numeric rating scale (NRS) is used to measure present pain intensity, pain for the last week and worst pain. The participant is asked to report an integer between 0-10 to assess the perceived pain, where "no pain" is rated as 0 and "worst possible pain" is rated as 10.
Number of patients using pain medications regularly
Time frame: 1.5 year
Participants are asked for their usage of pain medications (i.e. names of the drugs).
Physical activity
Time frame: 1.5 year
Two physical activity questions are used and answered by categories on a six-point (question 1) and seven-point Likert scale (question 2), respectively: 1. First question: During a regular week, how much time do you spend exercising on a level that makes you short winded, for example running, fitness class or ball games? Possible answers: 0 minutes, <30 minutes, 30-60 minutes, 60-90 minutes, 90-120 minutes, >120 minutes ( 2. Second question: During a regular week, how much time are you physically active in ways that are not exercise, for example walks, bicycling or gardening? Add together all activities lasting at least 10 minutes. Possible answers: 0 minutes, <30 minutes, 30-60 minutes, 60-90 minutes, 90-150 minutes, 150-300 minutes, >300 minutes
Patient enablement instrument (PEI)
Time frame: 1.5 year
The patient enablement instrument (PEI) is used to measure the patient's perceived change in ability to understand and cope with his or her health issues after the treatment period and contains six items. The text "As a result of the participating in the Osteoporosis School, do you feel that you are …" is followed by six items; 1) able to cope with life, 2) able to understand your illness, 3) able to cope with your illness, 4) able to keep yourself healthy, 5) confident about your health, and 6) able to help yourself. The following five alternative answers were used for each statement; much better/much more, better/more, same, less/worse and not applicable. The PEI point for much better/much more is 2; for better/more is 1; and for same, less/worse or not applicable is 0. These points are added and thus the total PEI score ranges between 0 (worst score) and 12 (best score).
Subjective experience of the patient education
Time frame: 1.5 year
The participants' overall experiences of the theoretical lectures (and the physical training) are scored on a six-level Likert scale (scores 0-6), where 5 is considered very satisfied and 0 is not at all satisfied.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Spångeus, Ass.Prof, MD principal investigator
Univerity Hospital Linköping, Linköping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education (Theory), Physical training and Mindfulness and medical yoga in group in people with Osteoporosis and Vertebral Fracture, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQoL) - disease specific (time frame: 1.5 year). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.