Clinical trial NCT05764031: Clinical Pilates and Aerobic Exercise in Menopause
Official title: Comparative Effects of Clinical Pilates Training and Aerobic Exercise on Menopausal Symptoms, Quality of Life, Sleep and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Menopause
Aerobic exercise
Pilates
Depression
Sleep
Quality of life
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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. Identification of the healthcare needs of menopausal women requires special attention. During menopause, hormonal, physical and emotional changes occur as a result of decreased estrogen levels. Psychological, somatic and atrophic changes occur in the early stages of menopause and cardiovascular disease and osteoporosis during late menopause.

Due to the complex nature of menopause, various approaches are employed in the treatment of menopausal symptoms. Hormone Replacement Therapy (HRT) is one of them. However, prolonged use of combined estrogen/progesterone therapy may increase the risk of breast cancer. Among the conservative treatment methods, exercise is the most reliable and effective approach. Exercise provides similar benefits as HRT. The effects of exercise may vary with the initiation and type of exercise and the individual level of adherence to exercise. During exercise, cardiovascular, respiratory and musculoskeletal systems work together. In the short-term, regular exercise increases endurance, reduces stress and encourages better sleep patterns in a short period of time. In the longer term, exercise can reduce the risk of coronary artery disease (CAD), hypertension (HT) and type 2 diabetes.

Various exercise approaches are employed including aerobic exercise, yoga, pilates and relaxation exercises. Mixed findings on the outcomes of exercise have been reported in published studies. In a study examining the effects of aerobic exercise, yoga and diet on vasomotor symptoms (VMS) in menopausal women, exercise and diet were found to have no effect, whereas yoga showed beneficial effects on VMS. 12-week yoga and aerobic exercises were not effective in improving actigraphic sleep parameters in menopausal women with hot flashes. Contrastingly, a 6-week walking exercise program was demonstrated to improve sleep quality of postmenopausal women. A study evaluating the effects of aerobic exercise on estrogen level, fat mass and muscle mass versus resistance exercises in postmenopausal women found that resistance exercises were more effective in improving these parameters. Usgu et al. reported that 8-week aerobic walking exercises provided a reduction in somatic and psychological complaints, had no effect on urogenital symptoms but improved quality of life in premenopausal women. A meta-analysis of randomized trials aiming to determine the impact of low-to-moderate-intensity exercises on depressive symptoms in middle-aged and older women found that both types of exercises were effective in alleviating depressive symptoms. Moderate-intensity (VO2 max 60%) walking exercises practiced for 4 months showed greater effects on menopausal symptoms, physical activity, depression, satisfaction with life, self-esteem and feelings of loneliness compared to control.

On the other hand, 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. The biopsychosocial effects of Pilates in menopausal women have been shown in many studies. Positive effects of a 12-week Pilates training on sleep quality, depression, fatigue and anxiety in postmenopausal women were previously demonstrated. An 8-week Pilates training was found to reduce depression by improving quality of life in menopausal women. A systematic review of published studies on the efficacy of Pilates exercises in the rehabilitation of several conditions including postmenopausal osteoporosis concluded that Pilates can be prescribed for effective management of postmenopausal osteoporosis. In a meta-analysis of the trials examining the effect of exercise on women with depression, Pilates training was shown to reduce depressive symptoms in postmenopausal women compared to control group in one study included in the analysis. In the same meta-analysis involving 25 studies, aerobic exercise training was found to provide similar effects on depressive symptoms when compared with other exercise methods.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Menopause Rating Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: 36-Item Short Form Health Survey
timeFrame: 8 weeks
measure: Beck Depression Inventory
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
References:
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citation: Buchanan DT, Landis CA, Hohensee C, Guthrie KA, Otte JL, Paudel M, Anderson GL, Caan B, Freeman EW, Joffe H, LaCroix AZ, Newton KM, Reed SD, Ensrud KE. Effects of Yoga and Aerobic Exercise on Actigraphic Sleep Parameters in Menopausal Women with Hot Flashes. J Clin Sleep Med. 2017 Jan 15;13(1):11-18. doi: 10.5664/jcsm.6376.
citation: Razzak ZA, Khan AA, Farooqui SI. Effect of aerobic and anaerobic exercise on estrogen level, fat mass, and muscle mass among postmenopausal osteoporotic females. Int J Health Sci (Qassim). 2019 Jul-Aug;13(4):10-16.