NCT05227976

Patient Education With or Without Physical Training or Mindfulness and Medical Yoga in Established Spinal Osteoporosis

Short- and Long-term Effects of Patient Education With or Without Physical Training or Mindfulness and Medical Yoga in Patients With Established Spinal Osteoporosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University Hospital, Linkoeping · Academic / Other
• Sex: All
• Age: 60 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis
• Vertebral Fracture

Interventions

Type	Name	Description
BEHAVIORAL	Patient education (Theory)	Theory/Lectures (1h/week) Interventions given once weekly for 10 weeks.
BEHAVIORAL	Physical training	Physical training group (1 hour/week) Interventions given once weekly for 10 weeks.
BEHAVIORAL	Mindfulness and medical yoga in group	Mindfulness/medical yoga in group (1hour/week) Interventions given once weekly for 10 weeks.

Timeline

• Start date: 2018-03-15
• Primary completion: 2020-01-30
• Completion: 2020-01-30
• First posted: 2022-02-08
• Last updated: 2023-05-10

Locations

1 site across 1 country: Sweden