Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05203029
Other study ID # 55516
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 5, 2022
Est. completion date July 29, 2022

Study information

Verified date August 2022
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date July 29, 2022
Est. primary completion date May 20, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - Patients aged between 20 to 65 years - Patients with stage ?-? 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Iran, Islamic Republic of Isfahan University of Medical Sciences Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary Changes in depression after twelve weeks of exercises Beck's depression inventory-? (BDI-?) 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04049695 - Improving Cognition After Cancer N/A
Completed NCT03696056 - Improving Brain Function After Breast Cancer Study N/A
Active, not recruiting NCT00981305 - Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors Phase 3
Active, not recruiting NCT03674437 - Evaluation of an Online, Remote Cognitive Battery for Use in Cancer Survivorship
Active, not recruiting NCT05743023 - Consciousness-based Ayurveda Lifestyle Program for Improving Quality of Life in Survivors of Breast Cancer N/A
Completed NCT02062255 - Impact of COX2 on Sera Biomarkers From Obese Subjects Phase 0
Active, not recruiting NCT04262180 - Physical Activity Promotion for Breast and Endometrial Cancer Survivors N/A
Active, not recruiting NCT04883398 - A Study of Attention and Memory Processes in Breast Cancer Survivors
Completed NCT01217216 - Cancer Survival Through Weight Loss and Exercise N/A
Completed NCT05506189 - Life Style Modification for Breast Canccer Survivors Using Mobile App-based Human Coaching Program
Recruiting NCT03644329 - Effect of Resistance Training Variable Manipulation in Postmenopausal Breast Cancer Survivors. N/A
Recruiting NCT05690295 - Resistance-type Exercise Training in Postmenopausal Women Survivors of Breast Cancer N/A
Recruiting NCT06073717 - Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (BRAINonFIT). N/A
Not yet recruiting NCT05848141 - Rowing Following Breast Cancer Chemotherapy N/A
Active, not recruiting NCT02726763 - Feasibility and Tolerability of Transcranial Direct Current Stimulation With Concurrent Cognitive Training N/A
Recruiting NCT03394690 - Effects of Green Coffee Extract Supplementation on Leptin, Ghrelin, Adiponectin,Anthropometric Measurements, Lipid Profile in Breast Cancer Survivors N/A
Completed NCT02753985 - Adherence to Aromatase Inhibitors: The Role of Partners
Active, not recruiting NCT04818359 - Movement and Health Beyond Care (MoviS) N/A
Completed NCT02672189 - Internet-based Cognitive Behavioral Therapy for Breast Cancer Patients With Climacteric Symptoms Phase 3
Recruiting NCT03395561 - Effects of Green Coffee Extract Supplementation on Adropin, Irisin, Vaspine,Systemic Inflammation and Oxidative Stress in Breast Cancer Survivors N/A