Clinical trial NCT05227976: Patient Education With or Without Physical Training or Mindfulness and Medical Yoga in Established Spinal Osteoporosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Vertebral Fracture
Keywords: patient education
yoga
mindfulness
physical training
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 31
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

1. Theory only (T group)
2. Theory and physical exercise (TPh-group)
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* inability to understand the Swedish language or difficulty following the research protocol or dementia

Primary outcomes:
measure: Health-related quality of life (HRQoL) - disease specific
timeFrame: 1.5 year
measure: Health-related quality of life (HRQoL) - generic
timeFrame: 1.5 year
measure: Body weight
timeFrame: 6 months
measure: Body height
timeFrame: 6 months
measure: Static balance test
timeFrame: 6 months
measure: Dynamic balance test
timeFrame: 6 months
measure: Muscle strength Chair-stand
timeFrame: 6 months
measure: Muscle strength Hand grip
timeFrame: 6 months
measure: C7 to wall distance
timeFrame: 6 months
measure: Pain assessment
timeFrame: 1.5 year
measure: Number of patients using pain medications regularly
timeFrame: 1.5 year
measure: Physical activity
timeFrame: 1.5 year
measure: Patient enablement instrument (PEI)
timeFrame: 1.5 year
measure: Subjective experience of the patient education
timeFrame: 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University Hospital Linköping
Study officials:
affiliation: Univerity Hospital Linköping, Linköping University
name: Anna Spångeus, Ass.Prof, MD
role: PRINCIPAL_INVESTIGATOR
References: