FatigueNCT05002894
Effect of Pilates Exercises On Fatigue In Post Menopausal Women
A study testing Pilates exercises in people with Fatigue, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Pilates exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- . 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.
Who cannot join
- • 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.
About this study
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.
Read the 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 .
- Conditions
- Fatigue
- Being tested
- Pilates exercises, medical standard care for fatigue
- Keywords
- fatigue, sleep disturbance
- Medical subject headings
- Fatigue, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
Pilates exercises for flexibility and stability
medical standard care for fatigueDietary supplement
supplements and medical care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pilates exercises; Dietary 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. Receives: Dietary Supplement: medical standard care for fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately before the intervention (baseline value) and after 8 weeks of intervention
Secondary outcomes (1)
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
Measured: immediately before the intervention (baseline value) and after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohamed Nabil Hussein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002894
- Sponsor's protocol ID
- Pilates Effect On Fatigue
- Status last verified
- Aug 2021
- First submitted
- 1 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercises On Fatigue In Post Menopausal Women
- ClinicalTrials.gov ID
- NCT05002894
- Acronym / sponsor ID
- Pilates Effect On Fatigue
- Conditions
- Fatigue
- Keywords
- fatigue, sleep disturbance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Other: Pilates exercises, Dietary Supplement: medical standard care for fatigueThis 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. |
| standard care group | Experimental | Dietary Supplement: medical standard care for fatigueEach post-menopausal woman in both groups will receive a medical standard care for post-menopausal fatigue. |
Who may qualify
- Ages
- 50 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- . 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.
Key exclusion criteria (7 listed)
- • Post-menopausal women who have Uncontrolled hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates exercisesPilates exercises for flexibility and stability | Other | exercise group |
| medical standard care for fatiguesupplements and medical care | Dietary supplement | exercise group, standard care group |
Primary outcome
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
1 secondary outcome
change in Intreluken-6 test
Time frame: immediately before the intervention (baseline value) and after 8 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises in people with Fatigue, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Fatigue Assessment Scale (time frame: immediately before the intervention (baseline value) and after 8 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.