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

University Hospital, Linkoeping

Status: Completed

Conditions: Osteoporosis; Vertebral Fracture

Treatments: Behavioral: Physical training; Behavioral: Mindfulness and medical yoga in group; Behavioral: Patient education (Theory)

Study type: Interventional

Funder types: Other

Identifiers

NCT05227976

SOL-study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 3 patient groups

Theory only

Active Comparator group

Description:

Once weekly for 10 weeks

Treatment:

Behavioral: Patient education (Theory)

Theory and physical training

Active Comparator group

Description:

Once weekly for 10 weeks

Treatment:

Behavioral: Physical training

Behavioral: Patient education (Theory)

Theory and mindfulness/medical yoga

Active Comparator group

Description:

Once weekly for 10 weeks

Treatment:

Behavioral: Mindfulness and medical yoga in group

Behavioral: Patient education (Theory)