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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05002894
Other study ID # Pilates Effect On Fatigue
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2021
Est. completion date February 2022

Study information

Verified date August 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pilates is a system of exercises using special apparatus, designed to improve physical strength, flexibility, and enhance mental awareness. Regular exercise of post-menopausal women has benefits of increased cardio-respiratory fitness, increased muscle strength and endurance, reduced body fatigue, improved morale, and increased ability to perform daily tasks with greater force.Thus the main objective of regular exercise is prevention of physical deterioration and optimizing functional capacity to improve overall postmenopausal women's quality of life.


Description:

Fatigue has a negative impact on quality of life of postmenopausal women. Fatigue can be an overwhelming experience impacting the physical, emotional and social aspects of them. Fatigue can prevent them from carrying out their usual activities of daily living ,Menopause-related fatigue can be caused by changing estrogen levels, but it is often compounded by common symptoms, chief symptoms among these are vasomotor symptoms, which are experienced by up to 80% of women and include hot flashes and night sweats that can disrupt sleep , Pilates exercise considered a complementary therapy to treat fatigue in postmenopausal women. Pilates exercises are a healthy and effective method for improving the functional capacity, flexibility, fatigue, depression and quality of life of post menopause women ,They include stretching and strengthening exercises with controlled and precise movements that have indicated both mental and physical effects on post-menopausal women healthThe purpose of physical training using Pilates is to improve body functioning based on core strengthening that include rectus abdomens, transverse abdomen, erector spine, diaphragm and pelvic floor muscles. The six basic principles of Pilates exercise are centralization, concentration, control, precision, respiration and flow .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 52
Est. completion date February 2022
Est. primary completion date January 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 55 Years
Eligibility Inclusion Criteria: . All participants will be sedentary. - All participants' ages will be ranged from 50-55 years. - All participants body mass index will not exceed 30 kg/m2. - All participants will be medically stable. - All participants will be able to ambulate independently. - All participants suffering from fatigue, when assessed with fatigue assessment scale (FAS) their scores should be >22. Exclusion Criteria: - • Post-menopausal women who have Uncontrolled hypertension. - Post-menopausal women who have Thyroid gland disorders. - Post-menopausal women who have History of syncope or arrhythmia induced by physical exercise. - Postmenopausal women who have any mental, neurological, vestibular, cardiovascular disorders or metabolic disease. - Postmenopausal women whose visual or hearing impairment did not allow possibility of intervention. - Postmenopausal women who have been received hormonal replacement therapy or any drug known to affect their physical activity. - Post-menopausal women who have any other problems that make it impossible to perform physical exercises.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pilates exercises
Pilates exercises for flexibility and stability
Dietary Supplement:
medical standard care for fatigue
supplements and medical care

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Other change in Pittsburgh Sleep Quality Index Self-report questionnaire that assesses sleep quality The scores range from 0 to 21, a score >5 be considered as a significant sleep disturbance. immediately before the intervention (base line value) and after 8 weeks of intervention
Primary change in Fatigue Assessment Scale Assess fatigue for postmenopausal women The total score ranges from 10 to 50.
A total FAS score < 22 indicates no fatigue.
A score = 22 indicates fatigue
immediately before the intervention (baseline value) and after 8 weeks of intervention
Secondary change in Intreluken-6 test Evaluate fatigue in post menopausal women it is a blood analysis It's normal range is 0-16.4 pg/mL
Values higher than 16.4 indicate fatigue
immediately before the intervention (baseline value) and after 8 weeks of intervention
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