Clinical Pilates and Aerobic Exercise in Menopause
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|ClinicalTrials.gov Identifier: NCT05764031|
Recruitment Status : Completed
First Posted : March 10, 2023
Last Update Posted : March 14, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Menopause||Other: Clinical pilates exercise Other: Aerobic exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparative Effects of Clinical Pilates Training and Aerobic Exercise on Menopausal Symptoms, Quality of Life, Sleep and Depression|
|Actual Study Start Date :||December 16, 2020|
|Actual Primary Completion Date :||April 20, 2022|
|Actual Study Completion Date :||July 26, 2022|
Experimental: Clinical pilates group
The clinical pilates group received a total of 40 min of exercise training, including 5 min of warm-up exercises, 30 min of clinical pilates exercises and 5 min of cooldown exercises. Clinical Pilates training was performed as group sessions under the supervision of a physiotherapist Exercise training was provided to the clinical pilates group 2 days a week over a period of 8 weeks.
Other: Clinical pilates exercise
Clinical pilates is an exercise modality in which postural muscles are worked out with various body movements, and involves multi-muscle synergies that improve spinal stabilization, flexibility and endurance.
Experimental: Aerobic exercise group
The aerobic exercise group received a total of 40 min of aerobic exercise training, including 5 min of warm-up exercises, 30 min of aerobic cycling exercise and 5 min of cooldown exercises. Aerobic exercises were performed individually under the supervision of a physiotherapist. Aerobic exercises were performed using an upright bike (HS-1200; Hattrick-Pro, Istanbul, Turkey). The exercises were planned as moderate-intensity exercises, at 60-70% of the maximum heart rate (MHR). Exercise training was provided to the aerobic exercise group 2 days a week over a period of 8 weeks.
Other: Aerobic exercise
Aerobic exercise (also known as endurance activities, cardio or cardio-respiratory exercise) is physical exercise of low to high intensity that depends primarily on the aerobic energy-generating process.
- Menopause Rating Scale [ Time Frame: 8 weeks ]This self-report questionnaire consists of 11 items in 3 subscales including somatic, urogenital and psychological complaints. The somatic dimension measures joint and muscle problems, sleep disturbances, hot flashes and cardiac discomfort. The psychological domain measures physical and mental exhaustion, anxiety, irritability and depressive mood. The urogenital domain measures sexual problems, vaginal dryness/soreness and bladder. Each item is assigned a score between 0 and 4, and possible total scores range from 0 (asymptomatic) to 44 (highest degree of complaints). Domain scores range from 0 to 16 for the somatic and psychological domains and from 0 and 12 for the urogenital domain.
- 36-Item Short Form Health Survey [ Time Frame: 8 weeks ]The new short-form health survey (SF-36) was developed by Ware and Sherbourne. In this study, the Turkish version of the SF-36 questionnaire validated by Kocyigit was used for the assessment of quality of life. The tool consists of 36 items in eight sections, including physical functioning, physical role functioning, emotional role functioning, social role functioning, general health perceptions, bodily pain, vitality/energy and mental health. Each item is assigned a score between 0 and 100 and averaged to obtain the subscale scores.
- Beck Depression Inventory [ Time Frame: 8 weeks ]The Beck Depression Inventory was developed by Beck in 1961 for the measurement of the severity of depression. The scale consists of 21 items, including 2 items for emotions, 11 items for cognitions, 2 items for behaviors, 5 items for physical symptoms and 1 item for interpersonal symptoms. Each answer is scored between 0 and 3, with a possible total score ranging from 0 to 63. Higher scores denote more severe depressive symptoms.
- Pittsburgh Sleep Quality Index [ Time Frame: 8 weeks ]Pittsburgh Sleep Quality Index (PSQI) is composed of 24 questions. Among them, 19 questions are self-rated questions and 18 of them are scored. The latter 5 questions are responded by the bed partner or roommate. The tool consists of 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each question is rated from 0 to 3. The sum of scores for the seven components yields the overall PSQI score. Higher scores indicate worse sleep quality
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|Ages Eligible for Study:||40 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Menopause is defined as the time in a woman's life when there is a decrease in ovarian function and permanent cessation of reproductive function|
|Accepts Healthy Volunteers:||No|
- Womens between the ages of 40 and 65
- diagnosis of menopause by a gynecologist and willingness to participate in the study
- Women with a systemic, cardiovascular or neurological disorder, surgical menopause, alcohol or substance abuse and those who missed more than 3 sessions of exercise training.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05764031
|Hasan Kalyoncu University|
|Gaziantep, Turkey, 27144|
|Responsible Party:||Serkan Usgu, Clinical Professor, Hasan Kalyoncu University|
|Other Study ID Numbers:||
|First Posted:||March 10, 2023 Key Record Dates|
|Last Update Posted:||March 14, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Quality of life