NCT05002894

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

July 1, 2021

Last Update Submit

August 10, 2021

Conditions

Keywords

fatiguesleep disturbance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • change in Intreluken-6 test

    immediately before the intervention (baseline value) and after 8 weeks of intervention

Other Outcomes (1)

  • change in Pittsburgh Sleep Quality Index

    immediately before the intervention (base line value) and after 8 weeks of intervention

Study Arms (2)

exercise group

EXPERIMENTAL

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 exercisesDietary Supplement: medical standard care for fatigue

standard care group

EXPERIMENTAL

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

Dietary Supplement: medical standard care for fatigue

Interventions

Pilates exercises for flexibility and stability

exercise group

supplements and medical care

exercise groupstandard care group

Eligibility Criteria

Age50 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FatigueParasomnias

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 2021

First Posted

August 12, 2021

Study Start

September 1, 2021

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

August 12, 2021

Record last verified: 2021-08