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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Survivors
• Intervention / Treatment: Other: Online exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of
    • Isfahan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic exercises; The warm-up for 5 minutes; stretching exercises include stretching the neck to the sides, stretching the muscles of the shoulder girdle, back, and legs for 10 minutes; resistance exercises for 15 minutes, which will initially be applied in a light and weight-bearing manner, and in each session, according to the patient's progress, using free lightweights; light aerobic exercise for 10 minutes standing, sitting and lying down by controlling patients' heartbeat; cool down for 5 minutes.	Other: Online exercise; 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.
Experimental: Laughter yoga; Breathing techniques for 20 minutes including deep breathing, diaphragmatic breathing, tap on immune-boosting centers like thymus; laughter concert for 20 minutes such as laughter for no reason, childish movements, release the inner child; and laughter meditation for 5 minutes.	Other: Online exercise; 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.
Active Comparator: Yoga; Meditation and deep breathing for 10 minutes; physical posture for 15 minutes; 15 minutes relaxation exercises; and 5 minutes mindfulness practices.	Other: Online exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the anxiety and depression levels after twelve weeks of exercises	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.	0 and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the general quality of life after twelve weeks of exercises	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	0 and 3 months
Changes in the disease-specific quality of life after twelve weeks of exercises	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.	0 and 3 months
Changes in the Insomnia severity after twelve weeks of exercises	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.	0 and 3 months
Changes in depression after twelve weeks of exercises	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.	0 and 3 months
Changes in chronic fatigue after twelve weeks of exercises	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.	0 and 3 months
Changes in mindfulness after twelve weeks of exercises	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.	0 and 3 months

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Principal Investigator: Fateme Abedini, MSc, Isfahan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): July 29, 2022

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Yoga; Aerobic exercises; Laughter yoga
• Additional Relevant MeSH Terms: Behavioral Symptoms; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Depression; Breast Neoplasms
• Other Study ID Numbers: 55516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No