Effect of Pilates Exercises On Fatigue In Post Menopausal Women

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fatigue
• Intervention / Treatment: Other: Pilates exercises; Dietary supplement: medical standard care for fatigue

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise group; 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.	Other: Pilates exercises; Pilates exercises for flexibility and stability; Dietary supplement: medical standard care for fatigue; supplements and medical care
Experimental: standard care group; Each post-menopausal woman in both groups will receive a medical standard care for post-menopausal fatigue.	Dietary supplement: medical standard care for fatigue; supplements and medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: fatigue; sleep disturbance
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: Pilates Effect On Fatigue

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No