Exercise TrainingNCT07128030
Moderate-Intensity Exercise and Pain Sensitization in Breast Cancer Survivors: A Case-Based Study
A study testing Exercise in people with Exercise Training and Breast Cancer, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The aim of this study was to evaluate the feasibility, safety, and acceptability of a supervised, combined moderate-intensity aerobic and resistance training program designed to reduce pain sensitization in BCS with persistent pain. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Exercise Training, Breast Cancer, Pain Management
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 23 Aug 2025to 23 Feb 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult women diagnosed with stage I-III breast cancer
- Completion of active treatment (surgery, chemotherapy, and/or radiotherapy) at least 6 months prior to enrollment
- Presence of persistent pain or altered sensation in the upper quadrant of the affected limb related to oncologic treatment
Who cannot join
- Bilateral breast cancer
- Locoregional recurrence
- Other malignancies
- Pre-existing pain not related to cancer treatment
- Neurological or cognitive disorders
- Non-Spanish speakers
- Contraindications to moderate-intensity physical activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad Rey Juan Carlos
Madrid
Francisco Fernández, PhD, 916 65 50 60, fasis.fernandez@urjc.es
About this study
The aim of this study was to evaluate the feasibility, safety, and acceptability of a supervised, combined moderate-intensity aerobic and resistance training program designed to reduce pain sensitization in BCS with persistent pain. Secondary objectives included assessing changes in pain intensity, somatosensory sensitivity, and temporal summation, while tertiary objectives focused on improvements in quality of life and functional capacity.
- Conditions
- Exercise Training, Breast Cancer, Pain Management
- Being tested
- Exercise
- Keywords
- pain severity, pain sensibilization, quantitative sensory testing, physical activity
- Medical subject headings
- Breast Neoplasms, Agnosia, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The experimental group completed a five-week supervised program combining moderate-intensity aerobic and resistance training (150 min/week). Intensity was monitored using the Borg and OMNI-Res scales after familiarization sessions. Adherence was encouraged through reminders, motivational messages, and follow-ups. Unlike prior studies, this intervention focused specifically on neurophysiological pain modulation. Sessions included step-based aerobic exercises and resistance training with elastic bands under safety protocols.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-Intensity Exercise | Experimental | The experimental group followed a structured five-week program combining moderate-intensity aerobic and resistance training, totaling 150 minutes per week, and supervised by physiotherapists. Exercise intensity was monitored using the Borg and OMNI-Res perceived exertion scales, with prior familiarization sessions provided. Adherence was supported through attendance tracking, reminder messages, and motivational feedback. Unlike previous studies focused on fatigue or quality of life, this protocol targeted pain modulation based on neurophysiological mechanisms. Sessions included step-based aerobic routines and resistance exercises with bands, with clear safety and effort guidelines in place. No drugs or devices were used during the intervention. Receives: Other: Exercise |
| Control Group | No intervention | Participants maintained usual activities for five weeks without changing exercise habits. No additional interventions (drugs, devices, or procedures) were applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence by Tolerance: number of incomplete sessions
This variable captures tolerance-related indicators, including number of incomplete sessions. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Adherence by Tolerance: number of sessions at moderate intensity
This variable captures tolerance-related indicators, including number of sessions at moderate intensity. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Adherence by Tolerance: number of participants completing at moderate intensity
This variable captures tolerance-related indicators, including number of participants completing at moderate intensity. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Adherence by Tolerance: number of progressions during the program
This variable captures tolerance-related indicators, including number of progressions during the program. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Adherence by Tolerance: final progression level reached
This variable captures tolerance-related indicators, including final progression level reached. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Adherence by Motivation: number of absences
This variable aggregates motivation-related indicators, including number of absences.This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Adherence by Motivation: percentage of sessions recovered after absence
This variable aggregates motivation-related indicators, including percentage of sessions recovered after absence. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Adherence by Motivation: number of dropouts
This variable aggregates motivation-related indicators, including number of dropouts.This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Adherence by Motivation: number of presence of positive sensations
This variable aggregates motivation-related indicators, including number of presence of positive sensations (e.g., satisfaction, motivation).This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Adherence by Motivation: number of occurrence of adverse effects
This variable aggregates motivation-related indicators, including number of occurrence of adverse effects.This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Secondary outcomes (11)
Brief Pain Inventory (BPI)
The BPI consists of 11 items: four assessing intensity and seven evaluating interference in areas such as general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life. Scores range from 0 to 10, with higher scores indicating greater pain or interference. The BPI has demonstrated strong test-retest reliability (0.59-0.94), internal consistency in cancer populations (Cronbach's alpha 0.81-0.89), and construct validity across various demographic and clinical subgroups
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Numerical Rating Scale (NRS)
Pain intensity was measured using the Numerical Rating Scale (NRS), which ranges from 0 ("no pain") to 10 ("worst imaginable pain"). This scale has shown high reproducibility in assessing pain exacerbations (Cohen's κ = 0.86) and overall pain intensity (Cohen's κ = 0.80)
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
A validated Spanish-language tool composed of seven yes/no items, with scores ranging from 0 to 24. A score of 12 or higher indicates a high probability of neuropathic pain, while a score below 12 suggests a low likelihood. The S-LANSS has demonstrated strong diagnostic properties, with 85% sensitivity and 80% specificity
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
SENSORIMOTOR CHARACTERISTICS: HANDGRIP STRENGTH
Handgrip strength was assessed using a Jamar hydraulic dynamometer set to the second handle position. Participants performed three 5-second maximal isometric contractions per hand, with 30-second rests between attempts. The average of the three trials was used for analysis, starting with the non-operated side. Standardized verbal instructions and countdowns were given to ensure consistency.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Somatosensorial status (QST): MECHANICAL DETECTION THRESHOLD (MDT)
Calibrated Von Frey monofilaments were applied perpendicularly to the skin until the filament just bent. Filament sizes were increased until the first sensation was detected, and the initial detectable filament was recorded. A descending series was then applied to identify the smallest filament still perceived. This ascending-descending method was repeated five times, and the method of limits was used to determine thresholds.
Standardized instructions: "With your eyes open, I will apply pressure using several filaments of varying stiffness. Some you may feel, others you may not. Then, with your eyes closed, please indicate each time you feel the stimulus. Close your eyes, and we will begin."
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Somatosensorial status (QST): MECHANICAL PAIN THRESHOLD (MPT)
Mechanical pain threshold was assessed using Von Frey filaments. Filaments were applied in ascending order until the participant first reported the sensation as painful. Then, a descending sequence identified the smallest filament still perceived as painful. The test was repeated five times, and the mean filament force (measured in grams) was recorded as the MPT.
Standardized instructions: "You will feel a sharp stimulus. Please tell me when the sensation becomes uncomfortable but not yet painful-approximately 4 out of 10 on the Numerical Pain Rating Scale (NPRS), where 0 = no pain and 10 = worst imaginable pain. Higher filament force indicates a higher pain threshold (less sensitivity)."
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Somatosensorial status (QST): PAIN FACILITATION
Temporal summation was evaluated using Von Frey filaments at the mechanical pain threshold. A single stimulus was applied to a fixed point, followed by a pain rating on the NRS (, 0-10). Then, 10 identical stimuli were delivered at a frequency of 1 Hz using a 60- bpm metronome. A second NRS score was collected immediately after. The procedure was repeated three times, and the average was used for analysis.
Standardized instructions: "We will apply the same sharp stimulus used in the previous test. Please rate your pain intensity on a scale from 0 to 10, where 0 means no pain and 10 indicates the worst imaginable pain. Keep your eyes closed during the procedure. First, rate your pain after one stimulus, and then again after the sequence of ten."
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Somatosensorial status (QST): PRESSURE PAIN THRESHOLD (PPT)
Pressure pain threshold was measured using a digital algometer (Wagner Instruments FPX 100). With the patient in a supine position, incremental pressure was applied perpendicularly to the skin until pain was first perceived. Three measurements were obtained per site, and the average was used for analysis. Assessments were conducted at the primary painful area, the contralateral upper limb, and the anterior thigh of a pain-free lower limb.
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Physical activity was assessed using the Global Physical Activity Questionnaire (GPAQ)
A self-reported instrument developed by the World Health Organization and validated for use in cancer populations and Spanish-speaking individuals. The GPAQ evaluates physical activity in three domains-occupational, transportation, and leisure-and also captures sedentary behavior, defined as daily time spent sitting or lying down, excluding sleep. Based on total activity scores, participants were classified as inactive (<100), mildly active (100-1951), moderately active (1952-5724), or vigorously active (≥5725) (Cleland et al., 2014).
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR23).
This 23-item questionnaire includes four functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and four symptom scales (side effects of therapy, breast symptoms, arm symptoms, and distress from hair loss). Responses are given on a 4-point Likert scale ranging from 0 ("not at all") to 4 ("very much")
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
CARDIOPULMONARY FITNESS
Functional capacity was assessed using the Siconolfi Step Test, a validated submaximal test for estimating maximal oxygen uptake (VO₂max) in cancer populations. The test was performed on a 10-inch (25.4 cm) step in three 3-minute stages, with 1-minute rest intervals. Cadence was controlled via metronome at 68 bpm (stage 1), 104 bpm (stage 2), and 136 bpm (stage 3), corresponding to 17, 26, and 32 steps per minute, respectively. Heart rate was recorded at 2:30 minutes into each stage using a POLAR monitor. The test was terminated if participants experienced cardiorespiratory symptoms, musculoskeletal discomfort, peripheral fatigue, inability to maintain cadence, an RPE of 10, or if heart rate exceeded 65% of age-predicted maximum (220 - age).
Measured: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start23 Aug 2025
- Primary completion23 Feb 2026 (estimated)
- Study completion23 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario Gregorio Marañon
- Responsible party
- Principal investigator, DeAsís-Fernández, Francisco, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128030
- Sponsor's protocol ID
- EDCM
- Status last verified
- Nov 2025
- First submitted
- 25 Jul 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderate-Intensity Exercise and Pain Sensitization in Breast Cancer Survivors: A Case-Based Study
- ClinicalTrials.gov ID
- NCT07128030
- Acronym / sponsor ID
- EDCM
- Conditions
- Exercise Training, Breast Cancer, Pain Management
- Keywords
- pain severity, pain sensibilization, quantitative sensory testing, physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Collaborators
- Hospital General Universitario Gregorio Marañon
- Study start
- 23 Aug 2025 (actual)
- Primary completion
- 23 Feb 2026 (estimated)
- Study completion
- 23 Feb 2026 (estimated)
- First posted
- 17 Aug 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.
The aim of this study was to evaluate the feasibility, safety, and acceptability of a supervised, combined moderate-intensity aerobic and resistance training program designed to reduce pain sensitization in BCS with persistent pain. Secondary objectives included assessing changes in pain intensity, somatosensory sensitivity, and temporal summation, while tertiary objectives focused on improvements in quality of life and functional capacity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-Intensity Exercise | Experimental | Other: ExerciseThe experimental group followed a structured five-week program combining moderate-intensity aerobic and resistance training, totaling 150 minutes per week, and supervised by physiotherapists. Exercise intensity was monitored using the Borg and OMNI-Res perceived exertion scales, with prior familiarization sessions provided. Adherence was supported through attendance tracking, reminder messages, and motivational feedback. Unlike previous studies focused on fatigue or quality of life, this protocol targeted pain modulation based on neurophysiological mechanisms. Sessions included step-based aerobic routines and resistance exercises with bands, with clear safety and effort guidelines in place. No drugs or devices were used during the intervention. |
| Control Group | No intervention | –Participants maintained usual activities for five weeks without changing exercise habits. No additional interventions (drugs, devices, or procedures) were applied. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult women diagnosed with stage I-III breast cancer
- Completion of active treatment (surgery, chemotherapy, and/or radiotherapy) at least 6 months prior to enrollment
- Presence of persistent pain or altered sensation in the upper quadrant of the affected limb related to oncologic treatment
Key exclusion criteria (7 listed)
- Bilateral breast cancer
- Locoregional recurrence
- Other malignancies
- Pre-existing pain not related to cancer treatment
- Neurological or cognitive disorders
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 |
|---|---|---|
| ExerciseThe experimental group completed a five-week supervised program combining moderate-intensity aerobic and resistance training (150 min/week). Intensity was monitored using the Borg and OMNI-Res scales after familiarization sessions. Adherence was encouraged through reminders, motivational messages, and follow-ups. Unlike prior studies, this intervention focused specifically on neurophysiological pain modulation. Sessions included step-based aerobic exercises and resistance training with elastic bands under safety protocols. | Other | Moderate-Intensity Exercise |
Primary outcome
Adherence by Tolerance: number of incomplete sessions
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
This variable captures tolerance-related indicators, including number of incomplete sessions. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance.
Adherence by Tolerance: number of sessions at moderate intensity
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
This variable captures tolerance-related indicators, including number of sessions at moderate intensity. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance.
Adherence by Tolerance: number of participants completing at moderate intensity
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
This variable captures tolerance-related indicators, including number of participants completing at moderate intensity. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance.
Adherence by Tolerance: number of progressions during the program
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
This variable captures tolerance-related indicators, including number of progressions during the program. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance.
Adherence by Tolerance: final progression level reached
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
This variable captures tolerance-related indicators, including final progression level reached. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on tolerance.
Adherence by Motivation: number of absences
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
This variable aggregates motivation-related indicators, including number of absences.This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation.
Adherence by Motivation: percentage of sessions recovered after absence
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
This variable aggregates motivation-related indicators, including percentage of sessions recovered after absence. This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation.
Adherence by Motivation: number of dropouts
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
This variable aggregates motivation-related indicators, including number of dropouts.This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation.
Adherence by Motivation: number of presence of positive sensations
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
This variable aggregates motivation-related indicators, including number of presence of positive sensations (e.g., satisfaction, motivation).This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation.
Adherence by Motivation: number of occurrence of adverse effects
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
This variable aggregates motivation-related indicators, including number of occurrence of adverse effects.This variable will be analyzed using contingency tables to evaluate therapeutic adherence based on motivation.
11 secondary outcomes
Brief Pain Inventory (BPI)
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Numerical Rating Scale (NRS)
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
SENSORIMOTOR CHARACTERISTICS: HANDGRIP STRENGTH
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Somatosensorial status (QST): MECHANICAL DETECTION THRESHOLD (MDT)
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Somatosensorial status (QST): MECHANICAL PAIN THRESHOLD (MPT)
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Somatosensorial status (QST): PAIN FACILITATION
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Somatosensorial status (QST): PRESSURE PAIN THRESHOLD (PPT)
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
Physical activity was assessed using the Global Physical Activity Questionnaire (GPAQ)
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR23).
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
CARDIOPULMONARY FITNESS
Time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.
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 24 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Exercise Training and Breast Cancer, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Nov 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence by Tolerance: number of incomplete sessions (time frame: Baseline (prior to intervention), immediately post-intervention (within 1 week), and at 6-month follow-up.). The study lists 10 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 24 Nov 2025.