An interventional study of Supervised individualized exercise programme in Breast Cancer and Breast Neoplasms, sponsored by University of Extremadura. Completed at 1 site in Spain. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Extremadura · Not applicable, Interventional, and Supportive care
Among 905 studies in Breast Neoplasms with a site in Spain — 164 open to participants now, 286 under way, 84 of them phase 3. Breast Neoplasms · Spain.
Among the 905 studies in Breast Neoplasms with a site in Spain, this one is the 771st largest by enrollment of the 805 interventional ones that give a count, is one of 60 that started in 2023, is one of 146 with no phase, and was the 902nd registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →164 of the 905 studies in Breast Neoplasms with a site in Spain are open now. Recruiting first, the newest first:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Sites in Spain
Ages 18+
Spanish Breast Cancer Research Group · Sites in Spain
Ages 18+
Daiichi Sankyo · Sites in Spain, United States, Belgium and 5 more countries
Ages 18+
Kenko Imalytics S.L. · Sites in Spain
Ages 18+ · Women only
Spanish Breast Cancer Research Group · Sites in Spain
Ages 18+ · Women only
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years to 70 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
905 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 174 · Phase 2 326 · Phase 3 224 · Phase 4 13
First in 1996; this study’s year is marked. 60 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 150 across the 805 interventional studies, 200 across the 97 observational. Of the 575 that completed or were terminated, 291 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
533 of 905 have an industry lead sponsor. The 10 most frequent:
University of Extremadura is the lead sponsor of 48 studies on the registry; 7 are open to participants now.
University of Extremadura has 2 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
81 of the studies in Breast Neoplasms with a site in Spain that are under way reach primary completion within a year, 21 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT03820830Phase 3ETOP IBCSG Partners FoundationPalbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer | 2026-12 |
| NCT03595592Phase 3Fondazione MichelangeloNeoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer | 2026-12-15 |
| NCT05909397Phase 3PfizerVepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer | 2026-12-30 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
Among the 905 studies in Breast Neoplasms with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This pilot study examines the effects of a 14-week supervised, individualized physical exercise programme on psychological, motivational, and physical outcomes in women recently diagnosed with breast cancer who are undergoing adjuvant treatment (chemotherapy, radiotherapy, and/or hormone therapy). Sixteen women participated in twice-weekly 1-hour supervised sessions combining aerobic exercise, strength training, joint mobility, flexibility, and relaxation techniques, informed by Self-Determination Theory to support autonomy, competence, and social relatedness. Outcomes assessed before and after the intervention included basic psychological needs, exercise motivation, self-esteem, quality of life, perceived physical condition, physical exercise frequency, and physical/anthropometric measures (handgrip strength, 6-minute walk test, skinfolds, waist and hip circumference).
Breast cancer survivors frequently experience chronic physical, physiological, and psychological sequelae that affect quality of life, and few meet physical activity recommendations during adjuvant treatment due to fatigue, pain, lack of time, and low motivation. Most prior research on exercise and motivation in this population has drawn on the theory of planned behaviour or social cognitive theory, with fewer studies grounded in Self-Determination Theory (SDT). According to SDT, motivation for physical activity depends on the satisfaction of three basic psychological needs (autonomy, competence, and relatedness), whose fulfilment is associated with more self-determined motivation, greater adherence, and psychological well-being.
This single-arm pilot intervention study analysed changes in psychological and motivational variables (exercise behavioural regulation, basic psychological needs, self-esteem), as well as changes in quality of life, well-being, physical abilities, body composition, and physical exercise frequency, in women who had recently undergone breast cancer surgery and were undergoing adjuvant treatment. The 14-week programme consisted of two supervised 1-hour sessions per week plus one additional hour of independent physical activity, addressing joint mobility, flexibility, aerobic exercise, strength, relaxation techniques, and breathing/posture education, while supporting autonomy (choice of exercises), competence (instruction on the purpose/benefits of each activity), and relatedness (group walks and a WhatsApp support group). Assessments were taken before and after the intervention using validated questionnaires and physical/anthropometric tests.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with breast cancer undergoing adjuvant treatment (chemotherapy, radiotherapy, and/or hormone therapy) who participated in a 14-week supervised exercise programme. The programme consisted of two supervised 1-hour group sessions per week, led by a specialised professional, plus one additional hour of independent physical activity per week. Sessions addressed joint mobility, flexibility, aerobic exercise, strength training, relaxation techniques, and breathing/posture education, and were designed to support autonomy (choice of exercises), competence (instruction on the purpose and benefits of each activity), and social relatedness (pre-session group walks and a WhatsApp peer-support group).
Behavioral: Supervised individualized exercise programme
A 14-week, twice-weekly (1 hour per session), professionally supervised exercise programme for women with breast cancer undergoing adjuvant treatment, combined with one additional hour of independent physical activity per week. Sessions integrated joint mobility, flexibility, aerobic exercise, strength training, relaxation techniques, and breathing/posture education. Unlike standard exercise-oncology programmes, this intervention was explicitly structured around Self-Determination Theory to target the three basic psychological needs: autonomy (participant choice of exercises), competence (clear instruction on the purpose and benefit of each exercise), and relatedness (pre-session group walks and a WhatsApp peer-support group), aiming to promote both physical recovery and self-determined motivation to exercise
Change in Basic Psychological Needs Satisfaction
Assessed using the Basic Psychological Needs Satisfaction Scale (BPNSS), an 18-item instrument covering autonomy, competence, and relatedness, rated on a 6-point Likert scale.
Time frame: Baseline and post-intervention (14 weeks)
Change in Exercise Behavioural Regulation (Motivation)
Assessed using the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3), a 23-item instrument covering intrinsic, integrated, identified, introjected, and external regulation, and demotivation, rated on a 5-point Likert scale.
Time frame: Baseline and post-intervention (14 weeks)
Change in Self-Esteem
Assessed using the Rosenberg Self-Esteem Scale, a 10-item instrument rated on a 4-point Likert scale.
Time frame: Baseline and post-intervention (14 weeks)
Change in Quality of Life
Assessed using the Functional Assessment of Cancer Therapy - Breast plus Arm Morbidity (FACT-B+4), a 42-item instrument covering physical, social/family, emotional, and functional well-being, and breast/upper-limb-specific concerns.
Time frame: Baseline and post-intervention (14 weeks)
Change in Perceived Physical Condition
Assessed using the International Fitness Scale (IFIS), a 5-item self-reported fitness questionnaire.
Time frame: Baseline and post-intervention (14 weeks)
Change in Perceived Autonomy Support
Assessed using the Perceived Support for Autonomy in Exercise Settings Scale (PSAESS), a 12-item instrument.
Time frame: Baseline and post-intervention (14 weeks)
Change in Handgrip Strength
Muscle strength of both hands measured in kilograms using a hand-held dynamometer.
Time frame: Baseline and post-intervention (14 weeks)
Change in Functional Capacity (6-Minute Walk Test)
Distance walked in 6 minutes, measured in metres.
Time frame: Baseline and post-intervention (14 weeks)
Change in Body Composition: Skinfold Thickness
Body skinfold thickness was measured in millimetres using a skinfold caliper (Harpenden Skinfold Caliper, HSB-B1, Baty/Quality Measurement Ltd, West Sussex, UK).
Time frame: Baseline and post-intervention (14 weeks)
Change in Body Composition: Circumferences
Waist and hip circumferences in centimetres using a tape measure (Holtain Ltd., Crosswell, Crymych, Pembrokeshire, United Kingdom)
Time frame: Baseline and post-intervention (14 weeks)
Change in Perceived Exertion
Assessed using the Borg Scale (Borg 1982). The Perceived Exertion is a 15 point category-ratio; the odd numbered categories have verbal anchors. Beginning at 6, "no exertion at all," and goes up to 20, "maximal exertion." Before testing, subjects were instructed on the use of the RPE scale (Noble et al., 1996). We use the scale with the clear differentiation between central as peripheral perceived exertion following the recommendations of the medical staff and under the guideline of Borg (1982), for applied studies.
Time frame: Baseline and post-intervention (14 weeks)
Change in Heart Rate
Initial and final heart rate measured using a heart rate monitor (beats per minute)
Time frame: Baseline and post-intervention (14 weeks)
Change in Physical Exercise Frequency
Minutes of moderate, vigorous, and very vigorous physical activity, measured using a wrist-worn activity tracker (Fitbit Charge 4).
Time frame: Continuously throughout the 14-week intervention
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after de-identification, will be made available as Supplementary Material accompanying the published article
Time frame: The dataset will be made available as Supplementary Material immediately upon publication of the article, with no end date.
Access criteria: The de-identified dataset will be freely and publicly accessible to anyone as Supplementary Material accompanying the published article, without requiring a formal request or approval.
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Sep 2024, 20 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 20 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Extremadura