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

NCT ID: NCT05203029

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2022-07-29

Brief Summary

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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

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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.

Conditions

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Breast Cancer Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Online exercise

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Online exercise

Intervention Type 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.

Yoga

Meditation and deep breathing for 10 minutes; physical posture for 15 minutes; 15 minutes relaxation exercises; and 5 minutes mindfulness practices.

Group Type ACTIVE_COMPARATOR

Online exercise

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Fateme Abedini

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fateme Abedini, MSc

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences

Locations

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Isfahan University of Medical Sciences

Isfahan, , Iran

Site Status

Countries

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Iran

Other Identifiers

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55516

Identifier Type: -

Identifier Source: org_study_id

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