Breast CancerNCT07843121
Supervised Exercise in Women With Breast Cancer
A study testing Supervised individualized exercise programme in people with Breast Cancer and Breast Neoplasms, run by University of Extremadura at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- Supervised individualized exercise programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2023to 23 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women recently diagnosed with breast cancer who had undergone breast cancer surgery.
- Currently receiving adjuvant treatment (chemotherapy, radiotherapy, and/or hormone therapy)
- Able to provide written informed consent
Who cannot join
- Known cardiac abnormalities, such as unstable angina or recent myocardial infarction.
- Any severe disability that could affect physical function, including severe arthritis.
- Current diagnosis of severe psychiatric illness (participants with minor psychiatric diagnoses were eligible if well enough to participate).
- Currently enrolled in another health behaviour trial or programme.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Sport Sciences, University of Extremadura
Cáceres, Cáceres, 10004
About this study
Official title: Psychological, Motivational, and Physical Effects of a Supervised Exercise Program in Women With Breast Cancer Undergoing Adjuvant Treatment: a Pilot Intervention Study.
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).
Read the detailed description
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.
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- Supervised individualized exercise programme
- Keywords
- Breast cancer, Quality of life, Motivation, Oncological rehabilitation, Physical exercise
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised individualized exercise programmeBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Intervention Group | Experimental | 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). Receives: Behavioral: Supervised individualized exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention (14 weeks)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention (14 weeks)
Change in Handgrip Strength
Muscle strength of both hands measured in kilograms using a hand-held dynamometer.
Measured: Baseline and post-intervention (14 weeks)
Change in Functional Capacity (6-Minute Walk Test)
Distance walked in 6 minutes, measured in metres.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: Baseline and post-intervention (14 weeks)
Change in Heart Rate
Initial and final heart rate measured using a heart rate monitor (beats per minute)
Measured: 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).
Measured: Continuously throughout the 14-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start13 Jan 2023
- Primary completion25 Sep 2024
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm pilot study with a pre-post design. All participants received the same 14-week supervised exercise intervention, and outcomes were assessed before and after the intervention (within-subject comparison). No control or comparison group was included, consistent with the exploratory/pilot nature of the study.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Leyton Román, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843121
- Sponsor's protocol ID
- UEX 94/2022
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological, Motivational, and Physical Effects of a Supervised Exercise Program in Women With Breast Cancer Undergoing Adjuvant Treatment: a Pilot Intervention Study.
- ClinicalTrials.gov ID
- NCT07843121
- Acronym / sponsor ID
- UEX 94/2022
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- Breast cancer, Quality of life, Motivation, Oncological rehabilitation, Physical exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 25 Sep 2026 (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 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).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm pilot study with a pre-post design. All participants received the same 14-week supervised exercise intervention, and outcomes were assessed before and after the intervention (within-subject comparison). No control or comparison group was included, consistent with the exploratory/pilot nature of the study.
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Intervention Group | Experimental | Behavioral: Supervised individualized exercise programmeWomen 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women recently diagnosed with breast cancer who had undergone breast cancer surgery.
- Currently receiving adjuvant treatment (chemotherapy, radiotherapy, and/or hormone therapy)
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- Known cardiac abnormalities, such as unstable angina or recent myocardial infarction.
- Any severe disability that could affect physical function, including severe arthritis.
- Current diagnosis of severe psychiatric illness (participants with minor psychiatric diagnoses were eligible if well enough to participate).
- Currently enrolled in another health behaviour trial or programme.
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 |
|---|---|---|
| Supervised individualized exercise programmeA 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 | Behavioural | Supervised Exercise Intervention Group |
Primary outcome
Change in Basic Psychological Needs Satisfaction
Time frame: Baseline and post-intervention (14 weeks)
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.
Change in Exercise Behavioural Regulation (Motivation)
Time frame: Baseline and post-intervention (14 weeks)
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.
Change in Self-Esteem
Time frame: Baseline and post-intervention (14 weeks)
Assessed using the Rosenberg Self-Esteem Scale, a 10-item instrument rated on a 4-point Likert scale.
10 secondary outcomes
Change in Quality of Life
Time frame: Baseline and post-intervention (14 weeks)
Change in Perceived Physical Condition
Time frame: Baseline and post-intervention (14 weeks)
Change in Perceived Autonomy Support
Time frame: Baseline and post-intervention (14 weeks)
Change in Handgrip Strength
Time frame: Baseline and post-intervention (14 weeks)
Change in Functional Capacity (6-Minute Walk Test)
Time frame: Baseline and post-intervention (14 weeks)
Change in Body Composition: Skinfold Thickness
Time frame: Baseline and post-intervention (14 weeks)
Change in Body Composition: Circumferences
Time frame: Baseline and post-intervention (14 weeks)
Change in Perceived Exertion
Time frame: Baseline and post-intervention (14 weeks)
Change in Heart Rate
Time frame: Baseline and post-intervention (14 weeks)
Change in Physical Exercise Frequency
Time frame: Continuously throughout the 14-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: 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
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised individualized exercise programme in people with Breast Cancer and Breast Neoplasms, run by University of Extremadura 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 4 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: finished, as of the sponsor's last update on 25 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Basic Psychological Needs Satisfaction (time frame: Baseline and post-intervention (14 weeks)). The study lists 3 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 2026.