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

NCT05203029 | Completed

• 1 other identifier: 55516
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivors

Keywords

Aerobic exercises; Laughter yoga; Yoga; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in the general quality of life after twelve weeks of exercises

  0 and 3 months

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

  0 and 3 months

• Changes in the Insomnia severity after twelve weeks of exercises

  0 and 3 months

• Changes in depression after twelve weeks of exercises

  0 and 3 months

• Changes in chronic fatigue after twelve weeks of exercises

  0 and 3 months

Study Arms (3)

Aerobic exercises

EXPERIMENTAL

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

Laughter yoga

EXPERIMENTAL

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

Yoga

ACTIVE COMPARATOR

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

Other: Online exercise

Interventions

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.

Aerobic exercises; Laughter yoga; Yoga

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Iran

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Fateme Abedini, MSc

  Isfahan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 24, 2022
• Study Start: January 5, 2022
• Primary Completion: May 20, 2022
• Study Completion: July 29, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)