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临床试验/NCT07843121
NCT07843121已完成不适用

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

University of Extremadura1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2023年1月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
Change in Basic Psychological Needs Satisfaction

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

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).

干预措施: Supervised individualized exercise programme (Behavioral)

结局指标

主要结局

Change in Basic Psychological Needs Satisfaction

时间窗: 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)

时间窗: 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

时间窗: Baseline and post-intervention (14 weeks)

Assessed using the Rosenberg Self-Esteem Scale, a 10-item instrument rated on a 4-point Likert scale.

次要结局

  • Change in Handgrip Strength(Baseline and post-intervention (14 weeks))
  • Change in Perceived Autonomy Support(Baseline and post-intervention (14 weeks))
  • Change in Quality of Life(Baseline and post-intervention (14 weeks))
  • Change in Perceived Physical Condition(Baseline and post-intervention (14 weeks))
  • Change in Functional Capacity (6-Minute Walk Test)(Baseline and post-intervention (14 weeks))
  • Change in Body Composition: Skinfold Thickness(Baseline and post-intervention (14 weeks))
  • Change in Body Composition: Circumferences(Baseline and post-intervention (14 weeks))
  • Change in Perceived Exertion(Baseline and post-intervention (14 weeks))
  • Change in Heart Rate(Baseline and post-intervention (14 weeks))
  • Change in Physical Exercise Frequency(Continuously throughout the 14-week intervention)

研究者

发起方
University of Extremadura
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marta Leyton Román

PHD, Associate Professor

University of Extremadura

研究点 (1)

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Supervised Exercise in Women With Breast Cancer | 临床试验