Breast Cancer SurvivorsNCT05203029
Effectiveness of Aerobic Exercises and Laughter Yoga Compared With Yoga in Anxiety/Depression Levels in Breast Cancer
A study testing Online exercise in people with Breast Cancer Survivors, run by Isfahan University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Online exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteIran
- Study dates
- 5 Jan 2022to 29 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer Survivors
- Being tested
- Online exercise
- Keywords
- Aerobic exercises, Laughter yoga, Yoga, Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Online exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 and 3 months
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start5 Jan 2022
- Primary completion20 May 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fateme Abedini, Isfahan University of Medical Sciences
- Investigators
- Fateme Abedini, MSc, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203029
- Sponsor's protocol ID
- 55516
- Status last verified
- Aug 2022
- First submitted
- 12 Jan 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05203029
- Acronym / sponsor ID
- 55516
- Conditions
- Breast Cancer Survivors
- Keywords
- Aerobic exercises, Laughter yoga, Yoga, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercises | Experimental | Other: Online exerciseThe 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. |
| Laughter yoga | Experimental | Other: Online exerciseBreathing 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. |
| Yoga | Active comparator | Other: Online exerciseMeditation and deep breathing for 10 minutes; physical posture for 15 minutes; 15 minutes relaxation exercises; and 5 minutes mindfulness practices. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online exercisePatients 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. | Other | Aerobic exercises, Laughter yoga, Yoga |
Primary outcome
Changes in the anxiety and depression levels after twelve weeks of exercises
Time frame: 0 and 3 months
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.
6 secondary outcomes
Changes in the general quality of life after twelve weeks of exercises
Time frame: 0 and 3 months
Changes in the disease-specific quality of life after twelve weeks of exercises
Time frame: 0 and 3 months
Changes in the Insomnia severity after twelve weeks of exercises
Time frame: 0 and 3 months
Changes in depression after twelve weeks of exercises
Time frame: 0 and 3 months
Changes in chronic fatigue after twelve weeks of exercises
Time frame: 0 and 3 months
Changes in mindfulness after twelve weeks of exercises
Time frame: 0 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fateme Abedini, MSc principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online exercise in people with Breast Cancer Survivors, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the anxiety and depression levels after twelve weeks of exercises (time frame: 0 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.