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

NCT ID: NCT06030128

Last Updated: 2024-02-28

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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People with non-specific low back pain (NSLBP) demonstrate diversified clinical signs and symptoms. It is because the cause of NSLBP is multifaceted. Due to the varied pathophysiology and clinical behavior, the 'one-suit-all' approach of physiotherapy treatment prescription for people with NSLBP is usually less effective in reducing pain and improving daily function.

Research on identifying subgroups of patients with NSLBP who would benefit from physiotherapy interventions could provide clinicians evidence-based guidelines and enhance the cost-effectiveness of health care service. Earlier research showed that people with NSLBP demonstrated a delay in core muscle activation and general wasting of the trunk and core muscle. These pathological changes support the use of core stability training (e.g., Pilates exercise) to manage people with NSLBP. However, effectiveness of core stability training have not been studied extensively in older adults.

Conditions

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Chronic Low-back Pain Older Adults Core Stabilization Exercise Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

75 participants will be randomized into the intervention group. Another 75 participants will be randomized into the waiting list control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Core stabilization exercise group

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.

Group Type EXPERIMENTAL

core stabilization exercise

Intervention Type 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.

waiting list control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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core stabilization exercise

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 1)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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Patrick Kwong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Patrick Kwong, PhD

Role: CONTACT

852-62353459

Facility Contacts

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Gladys Cheing, PhD

Role: primary

References

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Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Other Identifiers

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20230506002

Identifier Type: -

Identifier Source: org_study_id

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