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

NCT05227976 | Completed

• 1 other identifier: SOL-study
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Vertebral Fracture

Keywords

patient education; yoga; mindfulness; physical training

Outcome Measures

Primary Outcomes (14)

• 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)

  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.

  1.5 year

• Body weight

  Body weight (kg) is measured by a digital scale, and with the participant in an upright position without shoes.

  6 months

• Body height

  Body height (cm) is measured by a stadiometer with the participant in an upright position without shoes.

  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

  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.

  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.

  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.

  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.

  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.

  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).

  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: 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

  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).

  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.

  1.5 year

Study Arms (3)

Theory only

ACTIVE COMPARATOR

Once weekly for 10 weeks

Behavioral: Patient education (Theory)

Theory and physical training

ACTIVE COMPARATOR

Once weekly for 10 weeks

Behavioral: Patient education (Theory); Behavioral: Physical training

Theory and mindfulness/medical yoga

ACTIVE COMPARATOR

Once weekly for 10 weeks

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

Interventions

Patient education (Theory) BEHAVIORAL

Theory/Lectures (1h/week) Interventions given once weekly for 10 weeks.

Theory and mindfulness/medical yoga; Theory and physical training; Theory only

Physical training BEHAVIORAL

Physical training group (1 hour/week) Interventions given once weekly for 10 weeks.

Theory and physical training

Mindfulness and medical yoga in group BEHAVIORAL

Mindfulness/medical yoga in group (1hour/week) Interventions given once weekly for 10 weeks.

Theory and mindfulness/medical yoga

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

University Hospital Linköping

Linköping, 58185, Sweden

Location

MeSH Terms

Conditions

Osteoporosis; Spinal Fractures

Interventions

Patient Education as Topic; Physical Conditioning, Human; Mindfulness; Population Groups

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Demography; Population Characteristics

Study Officials

• Anna Spångeus, Ass.Prof, MD

  Univerity Hospital Linköping, Linköping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 8, 2022
• Study Start: March 15, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)