Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04346979
Other study ID # 0001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date November 1, 2020

Study information

Verified date September 2022
Source Istinye University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the postmenopausal period when the woman spent 1/3 of her life; Due to the lack of estrogen, some physical and psychological changes occur. These changes may cause some problems. For women who perceive menopause as the first step of old age, loss of physical strength, energy, attraction and fertility, menopause can also lead to anxiety. In addition to these, they are among the emotional changes in the menopausal period in symptoms such as hypersensitivity to events, fatigue, and insomnia. Sometimes it can even be seen in psychological disorders such as melancholy and depression. The new coronavirus pneumonia (COVID-19), which appeared in Wuhan in December 2019, started to appear in different countries soon after. All countries have taken measures to prevent the spread of this virus. To this end, Turkey remains at home on March 21, 2020, and has commissioned social isolation measures. Studies investigating the effects of social isolation show that psychological and physical problems occur in individuals. Studies have shown that yoga and mindfulness programs have an impact on people's anxiety, depression, and the ability to control themselves. The purpose of this study; To investigate the effectiveness of telerehabilitation based yoga and mindfulness programs on psychological resilience, physical awareness and physical activity in postmenopausal women in social isolation due to the COVID-19 outbreak. Using telerehabilitation-based home programs aims to use an innovative model.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria: - Being physically or perceptually competent to exercise, - No spinal pathology or deformity, - Volunteering to participate in the study, - Not having menstruation for at least 12 months - Hormonally, surgically induced or natural menopause-confirmed women Exclusion Criteria: - Those with serious heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker) - Those with inflammatory or systemic disease malignancy - Psychological dysfunction - Those who use corticosteroids

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Telerehabilitation-Based
25 volunteers postmenopausal women who are at home during the social isolation process due to the coronavirus outbreak will be included in this group. Online yoga and mindfulness protocol was created for individuals who will participate in the study. Each training protocol was planned as 30 minutes for 3 days a week for 6 weeks. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. Respiratory exercise was added to the training protocol. Individuals were asked to participate in the study via telerehabilitation system and aimed to do their exercises with a physiotherapist.
Video-Based
25 volunteers postmenopausal women who are at home during the social isolation process due to the coronavirus outbreak will be included in this group. Online yoga and mindfulness protocol was created for individuals who will participate in the study. Each training protocol was planned as 30 minutes for 3 days a week for 6 weeks. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The respiratory exercise was added to the training protocol. Video recordings containing only yoga and mindfulness training were sent to individuals. The participants were supervised by the researcher.

Locations

Country Name City State
Turkey Istinye University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istinye University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Brief Resilience Scale The scale was used to measure the psychological resilience of individuals and Smith et al. (2008) were developed by. It is a 5-point Likert type, 6-item self-reporting style measurement tool. After the items in the scale and reverse coded are translated, the high scores indicate high psychological soundness. 2 week
Primary Nottingham Health Profile Nottingham Health Profile was created in England in 1985 to evaluate the quality of life-related to health. The Nottingham Health Profile is a general quality of life questionnaire that assesses the level of individuals health problems and how they affect their daily life activities. 2 week
Primary Mindful Attention Awareness Scale Mindful Attention Awareness Scale developed by Brown and Ryan (2003) is a 15-item scale that measures the general tendency to be aware of and be mindful of instant experiences in daily life. It has a single factor structure and gives a single total score. High scores from the scale indicate that conscious awareness is high. It is a 6-point Likert type scale. 2 week
Primary The Body Awareness Questionnaire It is a questionnaire consisting of four subgroups (changes in body process, sleep-wake cycle, prediction at the onset of the disease, prediction of body responses) and a total of 18 expressions aimed at determining the normal or abnormal sensitivity level of the body composition. The participant is asked to score from one to seven figures for each statement. In the survey, the ratings are made as total points. A high score indicates that body sensitivity is better. 2 week
Primary Richard-Campbell Sleep Questionnaire It, developed by Richards in 1987, is a 6-item scale that evaluates the depth of night sleep, falling asleep, frequency of waking, awakening when awakened, the quality of sleep and the level of noise in the environment. Each item is evaluated on the chart between 0 and 100 with a visual analog scale technique. "0-25" score obtained from the scale indicates very poor sleep, and the "76-100" score indicates very good sleep. Scale total score is evaluated over 5 items, and item 6 evaluating the noise level in the environment is excluded from the total score assessment. As the score of the scale increases, the sleep quality of the patients also increases. 2 week
Primary Lateral bridge test The participant, who is on the non-dominant side, will be asked to create a support surface from the elbow with the lower arm, place the other hand on the waist, and build a bridge by lifting the hip and knee. The time that the balance is maintained will be recorded. 2 week
Primary Functional reach test It is applied functionally both for the balance of the individual and for measuring the amount of dynamic reach. The individual is asked to lie down as long as he/she can lie down without going over the heel and hip flexion. 2 week
Primary Beck Depression Scale It consists of 21 questions used to evaluate the emotional situation. Each question is graded between 0-3 and a high score indicates that depressive symptoms increase. 10-16 points indicate mild depressive symptoms, 17-29 points indicate moderate depressive symptoms and 30-63 points indicate severe depressive symptoms. 2 week
See also
  Status Clinical Trial Phase
Completed NCT05293847 - Postural Based Telerehabilitation in Mechanic Neck Pain N/A
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Completed NCT05205434 - Efficacy of Synchronous and Asynchronous Telerehabilitation in COVID-19 Discharges N/A
Completed NCT06206343 - Telerehabilitation With Transcutaneous Electrical Nerve Stimulation Chronic Neck Pain: N/A
Completed NCT05875480 - The Effectiveness of Telerehabilitation After Arthroscopic Meniscus Repair N/A
Active, not recruiting NCT04991857 - Technology-based Family-centered Empowerment Program for Heart Failure (T-FAME-HF) N/A
Active, not recruiting NCT06416332 - Development and Testing of a Tele-rehabilitation System for Adult Patients With Knee Osteoarthritis N/A
Active, not recruiting NCT05026957 - A Digitally-Supported Shared Decision Making Approach for Coronary Artery Disease Patients During Cardiac Rehabilitation N/A
Completed NCT05684926 - COVID-19 Pandemic Asthma Child Telerehabilitation Yoga N/A
Active, not recruiting NCT05145465 - The Effect of a Supervised Home-based Tele-rehabilitation Program on Patients With Type 2 Diabetes N/A
Completed NCT06065423 - Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema N/A
Completed NCT06159205 - Core Stability Via Telerehabitation on TKA N/A
Completed NCT05027620 - Feasibility of Motor-cognitive Home Training for Parkinson's Disease Using eHealth Technology N/A
Not yet recruiting NCT06095336 - Telerehabilitation and Conventional Physiotherapy Program for Caregivers of Individuals With Special Needs N/A
Completed NCT04405609 - Usability Study of "ArmAssist 2.0." Robot: Homecare Arm Rehabilitation in Stroke Patients N/A
Completed NCT05147285 - The Effect of Telerehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis N/A
Not yet recruiting NCT05564871 - Effectiveness of Occupational Therapy Teleintervention in Pediatric N/A
Not yet recruiting NCT05019157 - Cardiac Telerehabilitation Effectiveness Using Wearable Sensors N/A
Recruiting NCT05720858 - Telerehabilitation in Survival Breast Cancer Patients N/A
Recruiting NCT05312827 - Training Intervention and Program of Support (TIPS): Fostering Family-centred Telehealth in Pediatric Rehabilitation N/A