Core Stabilization Exercise Therapy in Chronic Lower Back Back Management in Community Dwelling Older Adults

NCT06030128 | Recruiting

• 1 other identifier: 20230506002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To develop an exercise program for older adults with low back pain. And,to develop a clinical prediction rule that could identify a subgroup of people with NSLBP Participants: 150 people aged between 40 to 80 with non-specific low back pain (NSLBP) for more than 6 months and is able to ambulate independently will be invited to join the study. People who had 1) previous spinal surgery; 2) LBP attributable to current pregnancy; 3) acute fracture, recent fall, tumour, or bone infection; and 4) experience of practising core-stability exercises in the past 6 months will be excluded. Study details will be explained to participants and written consent will be obtained prior the study. 75 participants will be randomized into the intervention group. Another 75 participants will be randomized into the waiting list control group. Assessment Participants will undergo two comprehensive assessments before and after the training, which includes: Surface electromyogram (EMG) on the lumbar spine and abdominal muscle, Inertial measurement unit (IMU) sensor for trunk movement, clinical assessment including. Prone instability test. Subjective assessments: Visual analogue scale score for pain, The Oswestry Low Back Pain Disability Questionnaire and Roland-Morris Disability Questionnaire. Intervention - 16 session structured exercise program All participants will undergo a 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6 - 8 per class Subjects will be divided into experimental and control groups. Participants in the control group will not receive exercise training at first but were evaluated at the same time as participants in the experimental group. The participant in the control group completed the exercise training after the post-assessment.

Conditions

Chronic Low-back Pain; Older Adults; Core Stabilization Exercise Therapy

Outcome Measures

Primary Outcomes (2)

• The Oswestry Low Back Pain Disability Questionnaire

  is a widely used questionnaire designed to assess the level of disability and functional impairment in individuals with lower back pain. The questionnaire consists of 10 sections, each focusing on a different aspect of daily living that might be affected by back pain, such as personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling. Each section is scored on a scale of 0 to 5, with higher scores indicating greater disability. The scores for all sections are then summed and converted to a percentage, which can range from 0% (no disability) to 100% (maximum disability).

  pre-intervention session (T1)

• The Oswestry Low Back Pain Disability Questionnaire

  is a widely used questionnaire designed to assess the level of disability and functional impairment in individuals with lower back pain. The questionnaire consists of 10 sections, each focusing on a different aspect of daily living that might be affected by back pain, such as personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling. Each section is scored on a scale of 0 to 5, with higher scores indicating greater disability. The scores for all sections are then summed and converted to a percentage, which can range from 0% (no disability) to 100% (maximum disability).

  post-intervention (8 weeks after start of intervention;T2)

Secondary Outcomes (16)

• Visual analogue scale (VAS) score for pain

  pre-intervention session (T1)

• Visual analogue scale (VAS) score for pain

  post-intervention (8 weeks after start of intervention;T2)

• Fear-Avoidance Belief Questionnaire

  pre-intervention session (T1)

• Fear-Avoidance Belief Questionnaire

  post-intervention (8 weeks after start of intervention;T2)

• Surface EMG

  pre-intervention session (T1)

Study Arms (2)

Core stabilization exercise group

EXPERIMENTAL

All participants will undergo 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6 - 8per class. Subjects will be divided into experimental and control groups.

Behavioral: core stabilization exercise

waiting list control group

NO INTERVENTION

Participants in the control group will not receive exercise training at first but were evaluated at the same time as participants in the experimental group.

Interventions

core stabilization exercise BEHAVIORAL

All participants will undergo a 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6-8 per class. Subjects will be divided into experimental and control groups.

Core stabilization exercise group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ）people aged between 40 to 80 with non-specific low back pain (NSLBP) for more than 6 months ；2）people is able to ambulate independently

You may not qualify if:

• \) previous spinal surgery; 2) LBP attributable to current pregnancy; 3) acute fracture, recent fall, tumour, or bone infection; and 4) experience of practising core-stability exercises in the past 6 months

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Related Publications (17)

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Central Study Contacts

Patrick Kwong, PhD

CONTACT

852-62353459; whkwong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 75 participants will be randomized into the intervention group. Another 75 participants will be randomized into the waiting list control group.

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: September 15, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

HK (1)