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NCT Number: NCT07843121

Supervised Exercise in Women With Breast Cancer

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).

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sport Sciences, University of Extremadura

Cáceres, 10004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Supervised individualized exercise programme

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Change in Quality of Life

    Time frame: Baseline and post-intervention (14 weeks)

    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.

  2. Change in Perceived Physical Condition

    Time frame: Baseline and post-intervention (14 weeks)

    Assessed using the International Fitness Scale (IFIS), a 5-item self-reported fitness questionnaire.

  3. Change in Perceived Autonomy Support

    Time frame: Baseline and post-intervention (14 weeks)

    Assessed using the Perceived Support for Autonomy in Exercise Settings Scale (PSAESS), a 12-item instrument.

  4. Change in Handgrip Strength

    Time frame: Baseline and post-intervention (14 weeks)

    Muscle strength of both hands measured in kilograms using a hand-held dynamometer.

  5. Change in Functional Capacity (6-Minute Walk Test)

    Time frame: Baseline and post-intervention (14 weeks)

    Distance walked in 6 minutes, measured in metres.

  6. Change in Body Composition: Skinfold Thickness

    Time frame: Baseline and post-intervention (14 weeks)

    Body skinfold thickness was measured in millimetres using a skinfold caliper (Harpenden Skinfold Caliper, HSB-B1, Baty/Quality Measurement Ltd, West Sussex, UK).

  7. Change in Body Composition: Circumferences

    Time frame: Baseline and post-intervention (14 weeks)

    Waist and hip circumferences in centimetres using a tape measure (Holtain Ltd., Crosswell, Crymych, Pembrokeshire, United Kingdom)

  8. Change in Perceived Exertion

    Time frame: Baseline and post-intervention (14 weeks)

    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.

  9. Change in Heart Rate

    Time frame: Baseline and post-intervention (14 weeks)

    Initial and final heart rate measured using a heart rate monitor (beats per minute)

  10. Change in Physical Exercise Frequency

    Time frame: Continuously throughout the 14-week intervention

    Minutes of moderate, vigorous, and very vigorous physical activity, measured using a wrist-worn activity tracker (Fitbit Charge 4).

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

Psychological, Motivational, and Physical Effects of a Supervised Exercise Program in Women With Breast Cancer Undergoing Adjuvant Treatment: a Pilot Intervention Study.

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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