The Effect of Attention Distraction on the Adherence to Exercise, in Chronic Low Back Pain Patients.

NCT07192809 | Not Yet Recruiting

• 1 other identifier: 20787/25/TFSKTH - 09/07/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to investigate whether the use of an attention distraction application during exercise increases patient adherence to exercise programs in chronic non-specific low back pain (CNSLBP). In addition, the study will examine whether higher adherence to exercise leads to improved outcomes in pain levels, functional capacity, kinesiophobia, quality of life, central sensitization, and pain catastrophizing.

Conditions

Chronic Low Back Pain (CLBP); Distraction Methods; Adherence to Care

Keywords

chronic low back pain; adherence; distraction; divided attention; chronic non specific low back pain

Outcome Measures

Primary Outcomes (6)

• Adherence to exercise

  Exercise Adherence Rating Scale in Greek (EARS-GR). The Exercise Adherence Rating Scale (EARS) is a questionnaire used to assess how well individuals adhere to prescribed exercise programs. It utilizes a 5-point Likert scale for each item, with higher scores indicating better adherence. The total score ranges from 0 to 24, with higher scores representing greater adherence.

  Baseline, Week 8, and follow-up (6 months).

• Adherence to exercise

  Measured through app recorded metrics, including number of sessions (number)

  During the 6 month intervention period.

• Adherence to exercise

  Measured through app recorded metrics, including duration per session (minutes)

  During the 6 month intervention period.

• Adherence to exercise

  Measured through app recorded metrics including frequency of use per week (minutes)

  During the 6 month intervention period

• Adherence to exercise

  Measured through app recorded metrics, including number of questions answered

  During the 6 month intervention period

• Adherence to exercise

  Measured through app recorded metrics, including total active time (minutes).

  During the 6 month intervention period

Secondary Outcomes (18)

• Pain Intensity

  Baseline, Week 8, and follow-up (6 months).

• Anxiety, Stress, and Depression

  Baseline, Week 8, and follow-up (6 months).

• Functionality

  Baseline, Week 8, and follow-up (6 months).

• Pain Catastrophizing

  Baseline, Week 8, and follow-up (6 months).

• Central Sensitization

  Baseline, Week 8, and follow-up (6 months).

Study Arms (2)

Distraction Group

EXPERIMENTAL

Experimental Group: Standard exercise program with Attention Distraction Application (AD-APP) Participants in this group will: * will be familiarized with the exercises on a separete day prior to testing. * Perform exercises while using an application designed to distract attention in order to achieve a cognitive-motor dual task (exercise task and cognitive task). * Follow the program for 8 weeks, attending non-supervised sessions per week. Every two weeks , there will be a progression that will be achieved by increasing the level of difficulty of each exercise. * Adherence to the exercise program will be tracked through digital monitoring within the application. * Stratified into IPAQ categories (low, moderate, high physical activity). Participants will be given special equipment including an elastic tubing load Thera BandTM (Akron, Ohio, USA).

Other: Stabilisation exercise, resistance exercise and distraction task

Control Group

ACTIVE COMPARATOR

Control Group: Standard exercise program without Attention Distraction Application (AD-APP) Participants in this group will: * will be familiarized with the exercises on a separete day prior to testing. * Perform the same exercises without attention distraction in order to achieve a single task (exercise task). * Follow the program for 8 weeks, attending non-supervised sessions per week. * Adherence to the exercise program will be tracked through EARS-GR. * Stratified into IPAQ categories (low, moderate, high physical activity). Participants will be given special equipment including an elastic tubing load Thera BandTM (Akron, Ohio, USA).

Other: stabilisation exercise and resistance exercises

Interventions

Stabilisation exercise, resistance exercise and distraction task OTHER

The 8-week exercise intervention consists of 25 minutes non supervised training while distracting their attention with a knowledge based application

Distraction Group

stabilisation exercise and resistance exercises OTHER

The 8-week exercise intervention consists of 25 minutes non supervised training without distracting their attention with a knowledge based application

Control Group

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Chronic non-specific low back pain (≥3 months)
• No physical therapy or structured exercise program in the last 3 months
• Willingness to use the attention distraction application (for the AD-APP group)
• Completion of the International Physical Activity Questionnaire (IPAQ)

You may not qualify if:

• History of spinal surgery
• Neurological conditions affecting movement
• Regular use of pain relief medication within the past two weeks
• Pregnancy
• Severe psychological disorders that may affect compliance

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University of Thessaly

Lamia, Central Greece, 35132, Greece

Location

Central Study Contacts

Kyriakos Martinos Petropoulakos, Msc

CONTACT

+41767836957; kpetropoul@uth.gr

Savvas Spanos, Phd

CONTACT

sspanos@uth.gr

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: Supervising Professor Dr Savvas Spanos

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: September 25, 2025
• Study Start: September 20, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

GR (1)