NIPH Clinical Trials Search

JAPANESE
JRCT ID: jRCT1060260019

Registered date:14/05/2026

Study on Back Muscle Exercise Instruction for Patients with Osteoporosis or Low Bone Mass Undergoing Lumbar Fusion Surgery

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedlumbar fusion surgery
Date of first enrollment23/01/2026
Target sample size56
Countries of recruitment
Study typeInterventional
Intervention(s)Before surgery, patients will receive instructions for home-based exercises combining back muscle exercises and lower limb exercises using an exercise instruction pamphlet. During the postoperative hospital stay, individualized postoperative exercise instruction will be provided in addition to rehabilitation delivered as usual care, including lower limb muscle stretching, gait training, and stair-climbing practice. After discharge, exercise instruction will focus mainly on back muscle exercises and walking exercises.

Outcome(s)

Primary OutcomeIncidence of mechanical complications within 1 year after surgery
Secondary OutcomeTime to mechanical complication onset Change in erector spinae cross-sectional area Change in intramuscular fat area of the erector spinae Change in maximal trunk extensor strength Changes in multifidus muscle activity during movement and range of motion of the spine and lower limb joints Change in Oswestry Disability Index (ODI) Change in Japanese Orthopaedic Association (JOA) score Change in Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) score Incidence of falls Change in low back pain Numerical Rating Scale (NRS) score Change in leg pain Numerical Rating Scale (NRS) score Change in numbness Numerical Rating Scale (NRS) score

Key inclusion & exclusion criteria

Age minimum>= 40age old
Age maximumNot applicable
GenderBoth
Include criteria1) Patients scheduled to undergo lumbar fusion surgery 2) Patients whose primary disease is vertebral fracture, lumbar spinal stenosis, degenerative lumbar spondylolisthesis, or adult spinal deformity 3) Patients diagnosed with low bone mass or osteoporosis before surgery 4) Patients with a Goutallier grade of 1 or higher for the multifidus muscle on preoperative magnetic resonance imaging 5) Male and female patients aged 40 years or older at the time of consent 6) Patients scheduled for outpatient follow-up at our hospital
Exclude criteria1)Patients for whom postoperative imaging assessment is difficult 2)Patients for whom motor function assessment is difficult 3)Patients who refused rehabilitation at the time of surgical explanation 4)Patients diagnosed with dementia 5)Patients with a history of psychiatric disorder 6)Patients who are not independently ambulatory 7)Patients judged by the principal investigator to be unsuitable for participation in this study

Related Information

Contact

Public contact
Name Kitsuda Yuki
Address 36-1 Nishi-cho, Yonago, Tottori 683-8504 Japan Tottori Japan 6838504
Telephone +81-859386862
E-mail y-kitsuda@tottori-u.ac.jp
Affiliation Tottori University Hospital
Scientific contact
Name Kitsuda Yuki
Address 36-1 Nishi-cho, Yonago, Tottori 683-8504 Japan Tottori Japan 683-8504
Telephone +81-859386862
E-mail y-kitsuda@tottori-u.ac.jp
Affiliation Tottori University Hospital