Exercise and Mindfulness in Patients With Non-specific Chronic Low Back Pain: The BACKFIT Project
NCT ID: NCT05443880
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
105 participants
INTERVENTIONAL
2022-01-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exercise
The exercise intervention will undergo a exercise program 2 days / week (45 minutes per session) during a period of 8 weeks.
Exercise
The exercise intervention will focus on working the core muscles, starting with low-intensity isometric contraction of the core muscles that stabilize the trunk; increasing intensity by performing functional tasks (phase 1: independent isometric contraction of transversus-abdominis and multifidus, phase 2: co-contraction and functional tasks of the deep trunk muscles; phase 3: functional task with load; phase 4: functional task with unstable surface)
Exercise + mindfulness
The exercise + mindfulness intervention will carry out a an exercise intervention together with mindfulness intervention 1 day / week (2.5 hour per session).
Exercise + mindfulness
The Mindfulness Based Stress Reduction (MBSR) program will strictly follow the protocol developed by Jon Kabat Zinn. Each session will include three activities: the presentation of a topic, moments of dialogue and exploration in group (using appreciative inquiry) and a Mindfulness practice. Participants will be provided with workbooks, audios with guided meditations, and instructions for practice at home. In addition, the Exercise + mindfulness intervention will include the exercise program described in the exercise intervention.
Control
The control group will be provided with the usual care received in the Physical Medicine and Rehabilitation Service: stretching, breathing and motor control exercises 2 days / week (45 minutes per session) during a period of 8 weeks
Control group
The control group will be provided with the usual care received in the Physical Medicine and Rehabilitation Service: stretching, breathing and motor control exercises 2 days / week (45 minutes per session) during a period of 8 weeks.
Interventions
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Exercise
The exercise intervention will focus on working the core muscles, starting with low-intensity isometric contraction of the core muscles that stabilize the trunk; increasing intensity by performing functional tasks (phase 1: independent isometric contraction of transversus-abdominis and multifidus, phase 2: co-contraction and functional tasks of the deep trunk muscles; phase 3: functional task with load; phase 4: functional task with unstable surface)
Exercise + mindfulness
The Mindfulness Based Stress Reduction (MBSR) program will strictly follow the protocol developed by Jon Kabat Zinn. Each session will include three activities: the presentation of a topic, moments of dialogue and exploration in group (using appreciative inquiry) and a Mindfulness practice. Participants will be provided with workbooks, audios with guided meditations, and instructions for practice at home. In addition, the Exercise + mindfulness intervention will include the exercise program described in the exercise intervention.
Control group
The control group will be provided with the usual care received in the Physical Medicine and Rehabilitation Service: stretching, breathing and motor control exercises 2 days / week (45 minutes per session) during a period of 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* Intend to participate in the intervention and perform all the tests included in the study.
* Able to read and understand informed consent, as well as the objective of the study.
* Able to walk and move without outside help.
* Able to communicate without problems
* Be between 18 and 65 years old.
Exclusion Criteria
* Having lumbar surgery as source of pain.
* Having acute or terminal illness.
* Having medical prescription that prevents the performance of the tests.
* Having injury or circumstance that makes it impossible to perform the tests correctly.
* Having other physical or mental illness that prevents participating in the intervention.
20 Years
65 Years
ALL
No
Sponsors
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University Hospital Virgen de las Nieves
OTHER
ISCIII
UNKNOWN
European Social Fund
OTHER
IBS Granada
OTHER
Responsible Party
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Víctor Segura Jiménez
Principal Investigator
Locations
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IBS.Granada
Granada, , Spain
Countries
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Other Identifiers
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IBS.Granada
Identifier Type: -
Identifier Source: org_study_id
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