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NCT Number: NCT05203029

Effectiveness of Aerobic Exercises and Laughter Yoga Compared With Yoga in Anxiety/Depression Levels in Breast Cancer

90% of breast cancer survivors experience cancer-related fatigue which decreases the physical activity. Moreover, due to the cancer treatments depression and anxiety will be happened. Previous studies showed the effect of physical activity on reduction of depression and anxiety; therefore the aim of this study is to evaluate the effectiveness of aerobic exercises and laughter yoga compared with yoga in anxiety and depression levels in breast cancer survivors.

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Key information

Conditions

Breast Cancer Survivors Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Isfahan University of Medical Sciences

Isfahan, Iran

About this study

204 breast cancer survivors will be randomized to each of these three groups: Group 1, 12 weeks aerobic exercises; Group 2, 12 weeks of laughter yoga; and Group 3, 12 weeks of yoga.

To assess the effectiveness of these exercises in depression and anxiety levels, patients will complete the hospital anxiety and depression scale (HADS) questionnaire before and after the 3-month exercise.

For secondary outcomes, patients will complete the following questionnaires before and after the 3-month exercise: 36-item short-form survey (SF-36), Minnesota Living with Heart Failure Questionnaire (MLHFQ), Insomnia Severity Index, Beck's depression inventory-Ⅱ (BDI-Ⅱ), Chalder's chronic fatigue syndrome, and five facet mindfulness questionnaire (FFMQ).

The effectiveness of the mentioned exercises in primary and secondary outcomes will be assessed using ANOVA/ANCOVA analysis by adjusting the baseline assessment. Mean difference (MD) and standardized mean difference (SMD) with their 95% confidence interval (CI) will be reported to show the effectiveness of aerobic exercises and laughter yoga compared with yoga in different outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged between 20 to 65 years
  • Patients with stage Ⅰ-Ⅲ of breast cancer
  • Chemotherapy is completed at least six months before registration
  • Lack of active participation in regular exercise programs

Exclusion criteria

  • Reluctance to cooperate and enter the study
  • Do not complete the questionnaires correctly
  • Have diseases such as severe heart failure (Minnesota Living with Heart Failure Questionnaire score more than 50), severe valvular disease, coronary stenosis of the heart, and metastatic cancer
  • Feel chest pain and dizziness during the exercise
  • Patients currently receiving treatment
  • Patients who do not have the physical ability to participate in the exercise
  • Patients with mental health disorders that cannot participate in the exercise

Treatment and study plan

Online exercise

Other

Patients in each group will be added to the specific group on Whatsapp, and the schedule and information about the exercise will be explained there. Furthermore, patients will be joined to particular pages on Instagram, and exercises will be performed through Live on that pages. All the patients will exercise for 12 weeks, two or three times every week.

Primary outcomes

  1. Changes in the anxiety and depression levels after twelve weeks of exercises

    Time frame: 0 and 3 months

    Hospital anxiety and depression scale (HADS) questionnaire will be used to determine the anxiety and depression levels. This questionnaire contains 14 questions, of which seven concern anxiety and seven concern depression. Each question is scored from 0 (never) to 3 (almost always); the final score will be 0 to 52, and the higher scores indicate greater anxiety and depression.

Secondary outcomes

  1. Changes in the general quality of life after twelve weeks of exercises

    Time frame: 0 and 3 months

    36-item short form survey (SF-36) questionnaire will be used to determine the quality of life. This questionnaire comprises 36 items and eight domains, including limitations in physical activities because of health problems, limitations in social activities because of physical or emotional issues, limitations in usual role activities because of physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities because of emotional problems, vitality (energy and fatigue), and general health perceptions. Each question is scored from 0 to 100; the final score is the average score from 0 to 100, and the higher scores show a better quality of life. The scores will be reported for each domain separately

  2. Changes in the disease-specific quality of life after twelve weeks of exercises

    Time frame: 0 and 3 months

    Minnesota Living with Heart Failure Questionnaire (MLHFQ) will be used to determine the disease-specific quality of life. It has 21 items in physical, emotional and socioeconomic dimensions; each item scored from 0 to 5 provides a total score between 0 to 105: the higher the score, the lower quality of life.

  3. Changes in the Insomnia severity after twelve weeks of exercises

    Time frame: 0 and 3 months

    The Insomnia Severity Index questionnaire will be used to determine the insomnia severity. It has seven questions; each item has a score from 0 to 4. The seven answers are added up to get a total score from 0 to 28. The higher scores represent severe insomnia.

  4. Changes in depression after twelve weeks of exercises

    Time frame: 0 and 3 months

    Beck's depression inventory-Ⅱ (BDI-Ⅱ) will be used to measure depression. This questionnaire has 21 questions scored from 0 to 3. The total score will calculate by adding up all the scores-the higher scores indicating the higher depression.

  5. Changes in chronic fatigue after twelve weeks of exercises

    Time frame: 0 and 3 months

    Chalder's chronic fatigue syndrome questionnaire will be utilized to measure chronic fatigue. This questionnaire has 14 items, eight items are about physical symptoms, and six other items are about mental symptoms. Each question scored between 0 to 3, and the total score will be 0 to 42. The higher the score, the more suffer from fatigue.

  6. Changes in mindfulness after twelve weeks of exercises

    Time frame: 0 and 3 months

    Mindfulness will be measured by five facet mindfulness questionnaire (FFMQ). It has 39 questions in five domains: observation, description, aware actions, non-judgmental inner experience, and non-reactivity. Each question scored between 1 to 5, and the total score will be in the range of 39 to 195. The higher score shows the higher mindfulness.

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Effectiveness of Aerobic Exercises and Laughter Yoga Compared With Yoga in Anxiety and Depression Levels of Breast Cancer Survivors; a Double-blind Three Arm Clinical Trial Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 24, 2022
Registry last updated
Aug 4, 2022

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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