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

NCT ID: NCT05227976

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2020-01-30

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.

Conditions

Osteoporosis; Vertebral Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Theory only

Once weekly for 10 weeks

Group Type: ACTIVE_COMPARATOR

Patient education (Theory)

Intervention Type: BEHAVIORAL

Theory/Lectures (1h/week)

Interventions given once weekly for 10 weeks.

Theory and physical training

Once weekly for 10 weeks

Group Type: ACTIVE_COMPARATOR

Patient education (Theory)

Intervention Type: BEHAVIORAL

Theory/Lectures (1h/week)

Interventions given once weekly for 10 weeks.

Physical training

Intervention Type: BEHAVIORAL

Physical training group (1 hour/week)

Interventions given once weekly for 10 weeks.

Theory and mindfulness/medical yoga

Once weekly for 10 weeks

Group Type: ACTIVE_COMPARATOR

Patient education (Theory)

Intervention Type: BEHAVIORAL

Theory/Lectures (1h/week)

Interventions given once weekly for 10 weeks.

Mindfulness and medical yoga in group

Intervention Type: BEHAVIORAL

Mindfulness/medical yoga in group (1hour/week)

Interventions given once weekly for 10 weeks.

Interventions

Patient education (Theory)

Theory/Lectures (1h/week)

Interventions given once weekly for 10 weeks.

Intervention Type: BEHAVIORAL

Physical training

Physical training group (1 hour/week)

Interventions given once weekly for 10 weeks.

Intervention Type: BEHAVIORAL

Mindfulness and medical yoga in group

Mindfulness/medical yoga in group (1hour/week)

Interventions given once weekly for 10 weeks.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Linkoeping

OTHER

Sponsor Role: lead

Responsible Party

Anna Spangeus

Associate Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Spångeus, Ass.Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Univerity Hospital Linköping, Linköping University

Locations

University Hospital Linköping

Linköping, , Sweden

Countries

Sweden

Other Identifiers

SOL-study

Identifier Type: -

Identifier Source: org_study_id