NCT07839052

Brief Summary

This research aims to investigate the effect of a core stabilization exercise programme, combined with usual physiotherapy care, on balance in older adults, aged over 65 years with chronic non-specific low back pain. Participants will be randomly allocated to either an intervention group, receiving the core stabilization exercise programme additional to usual physiotherapy care, or a control group receiving usual physiotherapy care, combined with a general mobility and strengthening exercise programme. Participants will be assessed at baseline, after 12 weeks (3 months), and at a 6-month follow-up.

Trial Health

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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
37mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 25, 2026

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2029

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2029

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

2.8 years

First QC Date

September 18, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

core stabilitycore stability exercisesaging adultsolder adultsbalancebalance exercisesrisk of fallsusual physiotherapy carelow back pain

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale

    The Berg Balance Scale (BBS) is a 14-item standardized clinical assessment tool used to evaluate functional balance in older adults. It assesses static and dynamic balance during functional activities, including transfers, standing balance, turning, and single-leg stance. Each item is scored from 0 to 4, with a higher total score indicating better balance performance.

    Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)

Secondary Outcomes (6)

  • Timed Up and Go

    Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)

  • Single Leg Stance test

    Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)

  • Sit to Stand test

    Baseline (T0), 12 weeks (T1), additional assessment at 6 months (T2)

  • Oswestry Disability Index

    Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)

  • SF-36 Health Survey

    Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)

  • +1 more secondary outcomes

Study Arms (2)

Core stabilisation exercises + usual physiotherapy care group

EXPERIMENTAL

Participants will receive a progressive core stabilization exercise programme combined with usual physiotherapy care. The intervention will be delivered twice per week for 12 weeks. Each intervention session will last approximately one hour.

Other: Core stabilisation exercises + usual physiotherapy care

Usual Physiotherapy care + General exercise programme group

ACTIVE COMPARATOR

Participants will receive a general exercise programme combined with usual physiotherapy care. The intervention will be delivered twice per week for 12 weeks. Each intervention session will last approximately one hour.

Other: Usual physiotherapy care + general exercise programme

Interventions

The core stabilization exercise programme will include activation, motor control and strengthening exercises targeting the deep and superficial trunk muscles. The programme will consist of exercises such as abdominal drawing-in maneuver, camel-cat exercise, bird dog, dead bug, bridges, modified front and side planks. The intervention will be individually progressed according to functional capacity and exercise tolerance. The duration of the exercise programme per session will be approximately 20-25 minutes, additional to approximately 5 minutes of warm-up and 5 minutes of cool-down. The usual physiotherapy care will include joint and soft-tissue mobilisation, myofascial release techniques, superficial heat, low-frequency TENS, postural education, ergonomic advice and advice relevant to the maintenance of physical activity. This component of the intervention will be the same for both groups.

Core stabilisation exercises + usual physiotherapy care group

Participants will receive usual physiotherapy care including interventions commonly used for the management of chronic low back pain. These will include joint and soft-tissue mobilisation, myofascial release techniques, superficial heat, low-frequency TENS, postural education, ergonomic advice and advice regarding physical activity. This component of the intervention will be the same for both groups. To ensure comparable overall treatment duration between groups, participants will perform approximately 20 minutes of general mobility and strengthening exercises for the spine and upper and lower limb, as well as stretching exercises, additional to moderate intensity walking exercises. This exercise programme will not include specific core stabilisation exercises or balance exercises.

Usual Physiotherapy care + General exercise programme group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years old or older.
  • They have to be diagnosed with chronic non-specific low back pain lasting for at least 3 months.
  • Low back pain intensity greater than 3/10 on the Visual Analog Scale (VAS).
  • Functional independence.
  • They have to be able to walk independently without assistive devices.
  • Adequate cognitive function and ability to understand and follow instructions.
  • Ability and willingness to provide written consent.

You may not qualify if:

  • Severe spinal disorders, including spinal stenosis with neurological deficits, recent vertebral fracture or spondylolisthesis.
  • Spinal surgery within the last 12 months.
  • Acute low back pain, lasting less than 6 weeks.
  • Neurological disorders affecting balance or postural control, including Parkinson's disease or stroke.
  • Vestibular disorders that may significantly affect balance.
  • Severe visual impairment or diagnosed cognitive impairment.
  • Malignancy.
  • Musculoskeletal or cardiopulmonary conditions at a level that affects and contraindicates exercise.
  • If they use regurarly hig-dose analgesic medication, specifically for the management of the symptoms of low back pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KINAISTHISI Physiotherapy Clinic Address: Pandora 2, Galatsi, 11146, Greece

Athens, Galatsi, 11146, Greece

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

EVA KOUTSAMPELA, PhD Canditate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Canditate

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 24, 2026

Study Start (Estimated)

October 25, 2026

Primary Completion (Estimated)

July 25, 2029

Study Completion (Estimated)

October 25, 2029

Last Updated

September 29, 2026

Record last verified: 2026-09

Locations