Chronic Low Back Pain (CLBP)PAINLESSNCT07192809
The Effect of Attention Distraction on the Adherence to Exercise, in Chronic Low Back Pain Patients.
A study testing Stabilisation exercise, resistance exercise and distraction task and stabilisation exercise and resistance exercises in people with Chronic Low Back Pain (CLBP) and Distraction Methods, run by University of Thessaly at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain (CLBP), Distraction Methods, Adherence to Care
- What is being tested?
- Stabilisation exercise, resistance exercise and distraction task and stabilisation exercise and resistance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 20 Sep 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Savvas Spanos, Phd contact
About this study
Official title: Chronic Non-Specific Low Back Pain: Investigating the Effectiveness of a Dual-Task Program as an Attention Distraction Strategy
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.
Read the detailed description
Participants will be stratified based on their level of physical activity according to the International Physical Activity Questionnaire (IPAQ) into:
- Low physical activity
- Moderate physical activity
- High physical activity
They will then be randomly assigned to one of two groups: (1) an experimental group using the attention distraction application during the standard exercise program and (2) a control group following the same standard exercise program without distraction. The intervention will last for 8 weeks, with participants attending three non-supervised sessions per week (total: 24 training sessions). Each session will last approximately 25-30 minutes. Adherence to the exercise program will be monitored through the EARS questionnaire and the distraction application (The total score ranges from 0 to 24, where a higher score reflects better adherence).
The intervention group sessions consist of 5 minute submaximal warm-up followed by 25 minutes of stabilisation and resistance training with exercises focused on strength and stabilisation while using the distraction application. The training will consist of two parts: warming-up and the resistance and stabilisation program. The resistance program will consist of 4 exercises: knee flexion, abdominal crunches, prone superman and leg extension. Each exercise will be performed for 3 sets of 10 repetitions with a rest of 30 sec corresponding to every set , and 1 minute between each exercise. The stabilisation program will consist of 3 exercises: bridge, plank and side plank. Each exercise will be performed for 3 sets of 1 repetition (maximum time) with a rest of 30 sec corresponding to every set and 1 minute between each exercise. Four levels of difficulty will be given for each exercise to allow for progression. Every 2 weeks, there will be a progression that will be achieved by increasing the resistance band tension, by changing the base of support or my modifying the length of resistance level arm.
In the control group they will perform the same exercises without the distraction-based application.
The exercise intensity will be monitored by the researcher, as determined by the patient's ability to complete three sets of 8-12 repetitions for a given exercise and a CR10scale. The progression will be in line with guidelines provided by the American College of Sports Medicine.
Adherence to the program for both groups will be assessed by the Exercise Adherence Rating Scale (EARS - GR).
- Being tested
- Stabilisation exercise, resistance exercise and distraction task, stabilisation exercise and resistance exercises
- Keywords
- chronic low back pain, adherence, distraction, divided attention, chronic non specific low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilisation exercise, resistance exercise and distraction taskOther
The 8-week exercise intervention consists of 25 minutes non supervised training while distracting their attention with a knowledge based application
stabilisation exercise and resistance exercisesOther
The 8-week exercise intervention consists of 25 minutes non supervised training without distracting their attention with a knowledge based application
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: stabilisation exercise and resistance exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8, and follow-up (6 months).
Adherence to exercise
Measured through app recorded metrics, including number of sessions (number)
Measured: During the 6 month intervention period.
Adherence to exercise
Measured through app recorded metrics, including duration per session (minutes)
Measured: During the 6 month intervention period.
Adherence to exercise
Measured through app recorded metrics including frequency of use per week (minutes)
Measured: During the 6 month intervention period
Adherence to exercise
Measured through app recorded metrics, including number of questions answered
Measured: During the 6 month intervention period
Adherence to exercise
Measured through app recorded metrics, including total active time (minutes).
Measured: During the 6 month intervention period
Secondary outcomes (18)
Pain Intensity
Numeric Pain Rating Scale (NPRS).
The Numeric Pain Rating Scale (NPRS) is a widely used tool for assessing pain intensity, typically ranging from 0 to 10. In this scale, 0 represents no pain, and 10 represents the worst pain imaginable. Patients are asked to verbally select a number that best reflects their pain level.
Measured: Baseline, Week 8, and follow-up (6 months).
Anxiety, Stress, and Depression
Depression, Anxiety, and Stress Scale (DASS-21).
The Depression Anxiety Stress Scales 21 (DASS-21) is scored by summing the responses to each of the three subscales: Depression, Anxiety, and Stress. Each subscale contains 7 items, and each item is scored on a scale of 0 to 3. The raw scores for each subscale are then multiplied by 2 to get the final score for each domain, which can range from 0 to 42.
Measured: Baseline, Week 8, and follow-up (6 months).
Functionality
Oswestry Disability Index (ODI).
The Oswestry Disability Index (ODI) is scored out of a total of 50 points, with each of the 10 sections having a maximum score of 5. To calculate the ODI score, sum the scores for each section, divide by the total possible score (50), and multiply by 100 to express it as a percentage.
Measured: Baseline, Week 8, and follow-up (6 months).
Pain Catastrophizing
Pain Catastrophizing Scale (PCS).
The Pain Catastrophizing Scale (PCS) is a 13-item questionnaire used to assess pain catastrophizing, with higher scores indicating greater levels of catastrophizing. Scores range from 0 to 52, and a score above 30 is considered clinically significant. The PCS also has three subscales: rumination, magnification, and helplessness.
Measured: Baseline, Week 8, and follow-up (6 months).
Central Sensitization
Central Sensitization Inventory (CSI).
The CSI, or Central Sensitization Inventory, is a questionnaire used to assess the severity of Central Sensitization Syndrome (CSS). It consists of 25 questions (Part A) scored on a 5-point Likert scale, with higher scores indicating more severe symptoms. Part B is not used for scoring but provides additional clinical information. The total score ranges from 0 to 100, with different ranges corresponding to different severity levels: subclinical (0-29), mild (30-39), moderate (40-49), severe (50-59), and extreme (60-100).
Measured: Baseline, Week 8, and follow-up (6 months).
Kinesiophobia
Tampa Scale of Kinesiophobia (TSK).
The Tampa Scale for Kinesiophobia (TSK) is a questionnaire used to assess fear of movement or re-injury, often related to chronic pain conditions. Scoring involves summing the responses to each item, with higher scores indicating greater kinesiophobia. The original TSK has 17 items, while a shorter version, TSK-11, has 11 items. The TSK-11 is more commonly used due to its reduced administration time and similar psychometric properties.
Measured: Baseline, Week 8, and follow-up (6 months)
Individual's health-related quality of life
12-Item Short Form Survey (SF-12)
The SF-12v2 scoring provides a Physical Component Summary (PCS) and a Mental Component Summary (MCS) score, both with a mean of 50 and a standard deviation of 10 in the US general population. Higher scores indicate better health on both scales. These scores are derived from the 12 individual items, which are scored and then transformed using regression weights to generate the PCS and MCS scores.
Measured: Baseline, Week 8, and follow-up (6 months)
Effect of Physical Activity Level
International Physical Activity Questionnaire (IPAQ).The patients will be categorized based on their level of physical activity, and accordingly, they will be assigned different exercise programs. Depending on their activity level, patients will perform exercises with a corresponding number of repetitions, weekly frequency, and intensity.
The International Physical Activity Questionnaire (IPAQ) scoring involves calculating Metabolic Equivalent of Task (MET) minutes per week to assess physical activity levels. The IPAQ scoring protocol provides guidelines for data processing and analysis, including recommendations for data cleaning. There are two main ways to express the results: as a continuous variable (MET-minutes per week) or categorized into low, moderate, or high activity levels. Investigate whether baseline physical activity level influences outcomes
Measured: Analyzed post-intervention based on IPAQ stratification
Work Productivity
Work Productivity and Activity Impairment Questionnaire - General Health (WPAI-GH Greek).
The Work Productivity and Activity Impairment Questionnaire - General Health (WPAI:GH) is a tool used to assess the impact of general health problems on work and daily activities over the past seven days. It consists of six questions that evaluate employment status, hours missed from work due to health problems, hours missed for other reasons, hours actually worked, and the degree to which health problems affected productivity while working and during regular daily activities. The last two questions are scored on a scale of 0 to 10, with 0 indicating no effect and 10 indicating complete impairment.
Measured: Baseline, Week 8, and follow-up (6 months)
Lumbar Mobility
Modified-Modified Schober Test.
The modified-modified Schober test (MMST) is a clinical assessment used to measure lumbar flexion range of motion. It involves marking two points on the back and measuring the distance between them while the patient bends forward, helping to quantify and track lumbar spine flexibility.
Measured: Baseline, Week 8, and follow-up (6 months).
Muscle Endurance
Modified Biering-Sorensen Test.
It shows that maintaining the Biering-Sorenson position for less than 176 seconds, predicts low back pain within the next year and greater than 198 seconds predicts absence of low back pain. It also reported that Biering-Sorenson test does not have a ceiling effect.
Measured: Baseline, Week 8, and follow-up (6 months).
Gait Analysis
Kinovea software for gait assessment.
The following parameter will be assessed using Kinovea software: step length (cm).
Measured: Baseline, Week 8, and follow-up (6 months).
Gait Analysis
Kinovea software for gait assessment. The following parameter will be assessed using Kinovea software: stride length (cm).
Measured: Baseline, week 8 and follow - up (6 months)
Gait Analysis
Kinovea software for gait assessment. The following parameter will be assessed using Kinovea software: knee range of motion (degrees).
Measured: Baseline, Week 8 and follow-up (6 months).
Gait analysis
Kinovea software for gait assessment. The following parameter will be assessed using Kinovea software: ankle angle (degrees).
Measured: Baseline, week 8 and follow-up (6 months)
Gait analysis
Kinovea software for gait assessment. The following parameter will be assessed using Kinovea software: knee angle (degrees).
Measured: Baseline, week 8 and follow-up (6 months)
Gait analysis
Kinovea software for gait assessment. The following parameter will be assessed using Kinovea software: pelvic tilt (degrees).
Measured: Baseline, Week 8 and follow- up (6 months)
Gait analysis
Kinovea software for gait assessment. The following parameter will be assessed using Kinovea software: base of support (cm).
Measured: Baseline, Week 8 and follow-up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savvas Spanos, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192809
- Sponsor's protocol ID
- 20787/25/TFSKTH - 09/07/2025
- Acronym
- PAINLESS
- Status last verified
- Sep 2025
- First submitted
- 13 Jul 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Non-Specific Low Back Pain: Investigating the Effectiveness of a Dual-Task Program as an Attention Distraction Strategy
- ClinicalTrials.gov ID
- NCT07192809
- Acronym / sponsor ID
- PAINLESS / 20787/25/TFSKTH - 09/07/2025
- Keywords
- chronic low back pain, adherence, distraction, divided attention, chronic non specific low back pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be stratified based on their level of physical activity according to the International Physical Activity Questionnaire (IPAQ) into:
- Low physical activity
- Moderate physical activity
- High physical activity
They will then be randomly assigned to one of two groups: (1) an experimental group using the attention distraction application during the standard exercise program and (2) a control group following the same standard exercise program without distraction. The intervention will last for 8 weeks, with participants attending three non-supervised sessions per week (total: 24 training sessions). Each session will last approximately 25-30 minutes. Adherence to the exercise program will be monitored through the EARS questionnaire and the distraction application (The total score ranges from 0 to 24, where a higher score reflects better adherence).
The intervention group sessions consist of 5 minute submaximal warm-up followed by 25 minutes of stabilisation and resistance training with exercises focused on strength and stabilisation while using the distraction application. The training will consist of two parts: warming-up and the resistance and stabilisation program. The resistance program will consist of 4 exercises: knee flexion, abdominal crunches, prone superman and leg extension. Each exercise will be performed for 3 sets of 10 repetitions with a rest of 30 sec corresponding to every set , and 1 minute between each exercise. The stabilisation program will consist of 3 exercises: bridge, plank and side plank. Each exercise will be performed for 3 sets of 1 repetition (maximum time) with a rest of 30 sec corresponding to every set and 1 minute between each exercise. Four levels of difficulty will be given for each exercise to allow for progression. Every 2 weeks, there will be a progression that will be achieved by increasing the resistance band tension, by changing the base of support or my modifying the length of resistance level arm.
In the control group they will perform the same exercises without the distraction-based application.
The exercise intensity will be monitored by the researcher, as determined by the patient's ability to complete three sets of 8-12 repetitions for a given exercise and a CR10scale. The progression will be in line with guidelines provided by the American College of Sports Medicine.
Adherence to the program for both groups will be assessed by the Exercise Adherence Rating Scale (EARS - GR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distraction Group | Experimental | Other: Stabilisation exercise, resistance exercise and distraction taskExperimental 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). |
| Control Group | Active comparator | Other: stabilisation exercise and resistance exercisesControl 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stabilisation exercise, resistance exercise and distraction taskThe 8-week exercise intervention consists of 25 minutes non supervised training while distracting their attention with a knowledge based application | Other | Distraction Group |
| stabilisation exercise and resistance exercisesThe 8-week exercise intervention consists of 25 minutes non supervised training without distracting their attention with a knowledge based application | Other | Control Group |
Primary outcome
Adherence to exercise
Time frame: Baseline, Week 8, and follow-up (6 months).
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.
Adherence to exercise
Time frame: During the 6 month intervention period.
Measured through app recorded metrics, including number of sessions (number)
Adherence to exercise
Time frame: During the 6 month intervention period.
Measured through app recorded metrics, including duration per session (minutes)
Adherence to exercise
Time frame: During the 6 month intervention period
Measured through app recorded metrics including frequency of use per week (minutes)
Adherence to exercise
Time frame: During the 6 month intervention period
Measured through app recorded metrics, including number of questions answered
Adherence to exercise
Time frame: During the 6 month intervention period
Measured through app recorded metrics, including total active time (minutes).
18 secondary outcomes
Pain Intensity
Time frame: Baseline, Week 8, and follow-up (6 months).
Anxiety, Stress, and Depression
Time frame: Baseline, Week 8, and follow-up (6 months).
Functionality
Time frame: Baseline, Week 8, and follow-up (6 months).
Pain Catastrophizing
Time frame: Baseline, Week 8, and follow-up (6 months).
Central Sensitization
Time frame: Baseline, Week 8, and follow-up (6 months).
Kinesiophobia
Time frame: Baseline, Week 8, and follow-up (6 months)
Individual's health-related quality of life
Time frame: Baseline, Week 8, and follow-up (6 months)
Effect of Physical Activity Level
Time frame: Analyzed post-intervention based on IPAQ stratification
Work Productivity
Time frame: Baseline, Week 8, and follow-up (6 months)
Lumbar Mobility
Time frame: Baseline, Week 8, and follow-up (6 months).
Muscle Endurance
Time frame: Baseline, Week 8, and follow-up (6 months).
Gait Analysis
Time frame: Baseline, Week 8, and follow-up (6 months).
Gait Analysis
Time frame: Baseline, week 8 and follow - up (6 months)
Gait Analysis
Time frame: Baseline, Week 8 and follow-up (6 months).
Gait analysis
Time frame: Baseline, week 8 and follow-up (6 months)
Gait analysis
Time frame: Baseline, week 8 and follow-up (6 months)
Gait analysis
Time frame: Baseline, Week 8 and follow- up (6 months)
Gait analysis
Time frame: Baseline, Week 8 and follow-up (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Savvas Spanos, Phd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilisation exercise, resistance exercise and distraction task and stabilisation exercise and resistance exercises in people with Chronic Low Back Pain (CLBP) and Distraction Methods, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyriakos Martinos Petropoulakos, Msc (+41767836957, kpetropoul@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to exercise (time frame: Baseline, Week 8, and follow-up (6 months).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.