NCT06946758

Brief Summary

The aim of the study is to evaluate the effects of aerobic exercise combined with core stabilisation training (CSE) in elderly individuals with chronic non-specific low back pain (CNSBP). The effects on functional capacity, quality of life, fall risk, functional status and physical performance will be investigated. Core stabilisation exercises will be applied to both groups. The aerobic exercise intervention group will receive aerobic exercise in addition to core stabilisation exercises. The evaluations will be performed before and after the treatment and the treatment is planned for 3 days a week for 8 weeks. The 6-minute walk test (6MWT) will be used to assess functional capacity, Visual Analogue Scale will be used to assess pain intensity, Oswestry Scale will be used to assess functional status in terms of low back pain, Biodex balance device will be used to assess fall risk, Beck Depression Scale will be used to assess depression, Tampa Kinesiophobia Scale will be used to assess kinesiophobia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

April 21, 2025

Last Update Submit

April 28, 2025

Conditions

Keywords

chronic low back pain

Outcome Measures

Primary Outcomes (3)

  • Pain Severity

    Visual Analogue Scale (VAS) was used to determine the presence and severity of low back pain in the study participants. GAS is a practical test with high validity and reliability in pain assessment. GAS is an assessment method numbered from 0 to 10, where '0' indicates no pain and '10' indicates the presence of the most severe pain. Participants were asked to mark the degree of pain they had on this scale and recorded.

    8 week

  • Disability

    Functional status was assessed using the Oswestry Disability Index (ODI). The OSI is a widely used questionnaire for the assessment of functional status in patients with low back pain. It includes subjective assessment. There are items including activities of daily living such as pain intensity, self-care, lifting, walking, sitting, standing, sleeping, social life and travelling information. The items are scored between 0-5. The final score is calculated by taking the patient's score as a percentage of the maximum score. Higher scores indicate an increasing level of disability. Turkish validity and reliability was performed by Yakut et al. in 1998.

    8 week

  • Risk of fall

    Biodex balance system (Biodex Medical System Inc., NY, USA, Model SW45-30D-E6N, SD 950-304) was used for fall risk assessment. This device creates stability indices by evaluating movements in the overall, anterior-posterior and right-left (medial-lateral) directions. Its validity and reliability have been established in this field. It has static and dynamic modes and 12 mobility levels of the platform (mobility level of the floor). In the limit of stability test, there are 9 balls, 1 in the middle and 8 on the edges, and when these balls light up, the person should move the centre of gravity to the burning ball and keep it there for 0.25 seconds. Each ball flashes once during the test and after the ball on the edge lights up, the ball in the centre lights up again. The aim is to move the centre of gravity in the specified direction. The test was performed three times and the extinguishing time of all balls was recorded by the device.

    8 week

Secondary Outcomes (3)

  • Cardiopulmonary capacity

    8 week

  • Depression

    8 week

  • Kinesiophobia

    8 week

Study Arms (2)

Control Group

OTHER

The control group will receive core stabilisation exercises 3 days a week for 8 weeks. Core exercise programme was applied to the patients three days a week for 8 weeks. The programme consisted of two weekly parts, and each part was planned according to the weeks by ordering from easy to difficult. Prior to the core stabilisation exercise programme, low intensity 5-10 min warm-up 30 min core exercises consisting of 3 levels were performed. Exercises progressed from easy to difficult according to the condition of the patients.

Other: Core stabilization exercises

Aerobic Exercise Group

EXPERIMENTAL

Core stabilisation exercises applied to the control group were applied to the aerobic exercise group. After the core stabilisation exercises, aerobic exercise was performed with a stationary bicycle at a speed of 50 rpm for approximately 40 minutes.

Other: Aerobic Exercises

Interventions

Patients in the core stabilisation exercise group underwent a total of 24 sessions of core stabilisation exercise programme 3 days a week (with at least 1 day of rest between each session) for a total of 8 weeks. Each exercise session was performed under the supervision of a physician in the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine. Each session was arranged as 35-minute programmes with an average of 8-10 patients, 5 minutes of which was warm-up. Before starting the exercise, patients were taught to reduce lumbar lordosis by contracting and drawing in the abdominal muscles and to find a lumbar and pelvic neutral position by moving the pelvis forwards and backwards. In each session, the neutral position was found first and attention was paid to maintain the neutral position throughout the exercise. The exercises consisted of 3 levels. The exercise level was completed gradually

Also known as: Control Group
Control Group

The aerobic exercise group underwent core stabilisation exercises applied to the control group. After the core stabilisation exercises, aerobic exercise was performed with a stationary bicycle at a speed of 50 rpm for approximately 40 minutes.

Aerobic Exercise Group

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients with complaints of low back pain for more than 3 months
  • Patients aged between 65-84 years
  • Patients with a mini-mental status test score above 24

You may not qualify if:

  • Those with radicular leg pain, sensory and motor deficits in the lower extremities and low back pain with inflammatory character
  • Those with previous spinal surgery, spondylolysis, spondylolisthesis, spinal stenosis, vertebral compression, fracture, previous or ongoing spinal infection in past history and examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

Location

Related Publications (1)

  • Kuzu S, Canli M, Valamur I, Ozudogru A, Alkan H, Hartavi A. Effects of aerobic exercise in addition to core stabilization exercises on functional capacity, physical performance and fall risk in geriatric individuals with chronic non-specific low back pain. BMC Sports Sci Med Rehabil. 2025 Jul 29;17(1):218. doi: 10.1186/s13102-025-01271-7.

MeSH Terms

Conditions

Low Back Pain

Interventions

Control GroupsExercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mehmet CANLI, PhD.

    Kirsehir Ahi Evran Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 21, 2025

First Posted

April 27, 2025

Study Start

July 1, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Consider briefly explaining why IPD will not or might not be shared.

Locations