Effect of Pilates Exercises On Fatigue In Post Menopausal Women

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05002894
Collaborator
(none)
52
2
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pilates exercises
  • Dietary Supplement: medical standard care for fatigue
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Pilates Exercises On Fatigue In Post Menopausal Women
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. change in Fatigue Assessment Scale [immediately before the intervention (baseline value) and after 8 weeks of intervention]

    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

  1. change in Intreluken-6 test [immediately before the intervention (baseline value) and after 8 weeks of intervention]

    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

Other Outcome Measures

  1. change in Pittsburgh Sleep Quality Index [immediately before the intervention (base line value) and after 8 weeks of intervention]

    Self-report questionnaire that assesses sleep quality The scores range from 0 to 21, a score >5 be considered as a significant sleep disturbance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amira Mohamed Nabil Hussein, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05002894
Other Study ID Numbers:
  • Pilates Effect On Fatigue
First Posted:
Aug 12, 2021
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amira Mohamed Nabil Hussein, Principal Investigator, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2021