Clinical trial NCT05203029: Effectiveness of Aerobic Exercises and Laughter Yoga Compared With Yoga in Anxiety/Depression Levels in Breast Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Survivors
Keywords: Aerobic exercises
Laughter yoga
Yoga
Depression
Anxiety
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 198
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the anxiety and depression levels after twelve weeks of exercises
timeFrame: 0 and 3 months
Secondary outcomes:
measure: Changes in the general quality of life after twelve weeks of exercises
timeFrame: 0 and 3 months
measure: Changes in the disease-specific quality of life after twelve weeks of exercises
timeFrame: 0 and 3 months
measure: Changes in the Insomnia severity after twelve weeks of exercises
timeFrame: 0 and 3 months
measure: Changes in depression after twelve weeks of exercises
timeFrame: 0 and 3 months
measure: Changes in chronic fatigue after twelve weeks of exercises
timeFrame: 0 and 3 months
measure: Changes in mindfulness after twelve weeks of exercises
timeFrame: 0 and 3 months
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Fateme Abedini, MSc
role: PRINCIPAL_INVESTIGATOR
References: