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Clinical Pilates and Aerobic Exercise in Menopause

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05764031
Recruitment Status : Completed
First Posted : March 10, 2023
Last Update Posted : March 14, 2023
Information provided by (Responsible Party):
Serkan Usgu, Hasan Kalyoncu University

Brief Summary:
To the best of our knowledge, there is no study in the literature that examined the effects of clinical Pilates training on vasomotor symptoms, quality of life, depression, and sleep problems versus aerobic exercises in menopausal women. This study aimed to investigate the effects of clinical Pilates training and aerobic exercises on menopausal symptoms, depression and quality of life and sleep quality in menopausal women.

Condition or disease Intervention/treatment Phase
Menopause Other: Clinical pilates exercise Other: Aerobic exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Womens between the ages of 40 and 65
  • diagnosis of menopause by a gynecologist and willingness to participate in the study

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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

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Hasan Kalyoncu University
Gaziantep, Turkey, 27144
Sponsors and Collaborators
Hasan Kalyoncu University
Publications of Results:

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Responsible Party: Serkan Usgu, Clinical Professor, Hasan Kalyoncu University
ClinicalTrials.gov Identifier: NCT05764031    
Other Study ID Numbers: 2020/114
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Serkan Usgu, Hasan Kalyoncu University:
Aerobic exercise
Quality of life