Effect of Pilates Exercises On Fatigue In Post Menopausal Women

August 10, 2021 updated by: Amira Mohamed Nabil Hussein, Cairo University
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in Fatigue Assessment Scale
Time Frame: 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
immediately before the intervention (baseline value) and after 8 weeks of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in Intreluken-6 test
Time Frame: 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
immediately before the intervention (baseline value) and after 8 weeks of intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in Pittsburgh Sleep Quality Index
Time Frame: 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.
immediately before the intervention (base line value) and after 8 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings