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Effect of Pilates Exercises On Fatigue In Post Menopausal Women

Primary Purpose

Fatigue

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pilates exercises
medical standard care for fatigue
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring fatigue, sleep disturbance

Eligibility Criteria

50 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    exercise group

    standard care group

    Arm Description

    This group included twenty six post-menopausal women. They will participate in Pilates exercise, medical standard care for fatigue and advices to deal with fatigue. The Pilates exercises consisted of a set of 10 movements: bridging; hundred; roll up; one leg circle (both ways); single straight leg stretch; single leg kick; side kick up and down; side kick circles; rest position (stretch and relaxation); and curling ,women were instructed to perform 30 min per session, 3 sessions per week, for 8 weeks.

    Each post-menopausal woman in both groups will receive a medical standard care for post-menopausal fatigue.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    July 1, 2021
    Last Updated
    August 10, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05002894
    Brief Title
    Effect of Pilates Exercises On Fatigue In Post Menopausal Women
    Official Title
    Effect of Pilates Exercises On Fatigue In Post Menopausal Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    February 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    Detailed 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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatigue
    Keywords
    fatigue, sleep disturbance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    exercise group
    Arm Type
    Experimental
    Arm Description
    This group included twenty six post-menopausal women. They will participate in Pilates exercise, medical standard care for fatigue and advices to deal with fatigue. The Pilates exercises consisted of a set of 10 movements: bridging; hundred; roll up; one leg circle (both ways); single straight leg stretch; single leg kick; side kick up and down; side kick circles; rest position (stretch and relaxation); and curling ,women were instructed to perform 30 min per session, 3 sessions per week, for 8 weeks.
    Arm Title
    standard care group
    Arm Type
    Experimental
    Arm Description
    Each post-menopausal woman in both groups will receive a medical standard care for post-menopausal fatigue.
    Intervention Type
    Other
    Intervention Name(s)
    Pilates exercises
    Intervention Description
    Pilates exercises for flexibility and stability
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    medical standard care for fatigue
    Intervention Description
    supplements and medical care
    Primary Outcome Measure Information:
    Title
    change in Fatigue Assessment Scale
    Description
    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
    Time Frame
    immediately before the intervention (baseline value) and after 8 weeks of intervention
    Secondary Outcome Measure Information:
    Title
    change in Intreluken-6 test
    Description
    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
    Time Frame
    immediately before the intervention (baseline value) and after 8 weeks of intervention
    Other Pre-specified Outcome Measures:
    Title
    change in Pittsburgh Sleep Quality Index
    Description
    Self-report questionnaire that assesses sleep quality The scores range from 0 to 21, a score >5 be considered as a significant sleep disturbance.
    Time Frame
    immediately before the intervention (base line value) and after 8 weeks of intervention

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Pilates Exercises On Fatigue In Post Menopausal Women

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