Comparison of the Effect of Exercises on Vasomotor Symptoms in Middle Aged Women

NCT05892094 | Completed

• 1 other identifier: E-10840098-772.02-754
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Vasomotor symptoms (VMS) develop in the premenopausal period and symptoms may persist for years after menopause.Vasomotor symptoms such as hot flashes, night sweats, mood swings and sleep disturbances affect women's quality of life. There is a need for alternative treatments to reduce vasomotor symptoms due to the inadequacy of current treatments and the need for an effective treatment. Exercise is seen as a low-risk treatment to reduce vasomotor symptoms. Resistance trainig combined with aerobic training may be effective in reducing vasomotor symptoms and improving quality of life. The effects of the combination of resistance trainig 2 days a week and aerobic trainig 3 days a week on vasomotor symptoms, quality of life, sleep disturbance and depression will be investigated and compared with the control group.

Conditions

Hot Flashes; Menopause

Keywords

Exercise; Hot flashes; Menopause; Resistance training; Aerobic exercise; Vasomotor symptoms; Quality of life; Sleep quality

Outcome Measures

Primary Outcomes (3)

• Change in vasomotor sypmtoms

  It will be assessed with vasomotor domain of the The Menopause-specific Quality of Life (MENQOL) Questionnaire. The MENQOL assesses the impact of the menopausal symptoms and one of the four domains is vasomotor symptoms.

  Baseline (Before intervention) and at the end of the intervention after 12 weeks

• Change in the Menopause-specific Quality of Life (MENQOL) Questionnaire

  The MENQOL is a validated questionnaire for the assessment of menopausal women's symptoms and an effective instrument. The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor, psychosocial, physical, and sexual.

  Baseline (Before intervention) and at the end of the intervention after 12 weeks

• Change in the Menopause Rating Scale (MRS)

  MRS is a health-related quality of life scale (HRQoL) and was developed in response to the lack of standardized scales to measure the severity of aging-symptoms and their impact on the HRQoL. The MRS consists of a list of 11 items. Each of the eleven symptoms contained in the scale can get 0 (no complaints) or up to 4 scoring points (severe symptoms) depending on the severity of the complaints perceived by the women completing the scale.

  Baseline (Before intervention) and at the end of the intervention after 12 weeks

Secondary Outcomes (1)

• Change in the Pittsburgh Sleep Quality Index (PSQI)

  Baseline (Before intervention) and at the end of the intervention after 12 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

Participants will participate in a 12-week full-body resistance and aerobic exercise program. It will include full body resistance exercises two days a week and aerobic exercise program three days a week. For aerobic exercise, participants will be asked to do brisk walking 3 days a week. Participants will be called regularly to monitor their participation in the aerobic exercise program. Resistance exercises sessions will be supervised by a physical therapist. Each resistance training session will include five minutes of warm-up, forty minutes of resistance training and five minutes of cool-down. Resistance exercises will consist of weight-bearing exercises performed with the participant's own body weight. Participants in the exercise group will complete the questionnaires at baseline and after 12 weeks at the end of the intervention.

Other: Resistance and Aerobic Training

Control Group

NO INTERVENTION

Participants in the control group were instructed not to change their physical activity habits during 15 weeks and to avoid any other treatment for vasomotor symptoms. Participants in the control group will complete the questionnaires at baseline and after 12 weeks.

Interventions

Resistance and Aerobic Training OTHER

For aerobic exercise, participants will do brisk walking 30 minutes in the first two weeks, 3-6. weeks will be 35 minutes, 7th and 8th weeks will be 40 minutes.The first and last 10 minutes of each walk will be said to be done at a slow pace, for the warm-up and cool-down periods. Participants will be called regularly to monitor their participation in the aerobic exercise program, and their compliance with the exercise will be checked, and they will be motivated to continue the exercises by providing the necessary information. Resistance exercises sessions will include five minutes of warm-up, forty minutes of resistance training and five minutes of cool-down. The training load will be provided by progressively increasing the repetitions. The Borg Scale will be used to adjust the exercise intensity. Rest time between sets will be 60 seconds.

Exercise Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Physiologic female participants with vasomotor symptoms associated with menopause will be included in the study. Physiologically, the selection of the female sex is due to the fact that physiological menopause is specific to women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women between the ages of 40-65
• Those who report moderate or severe vasomotor symptoms
• Those who have not received hormone replacement therapy for at least 3 months
• Maximum of 225 minutes of physical activity per week

You may not qualify if:

• Receiving medical treatment for menopausal symptoms in the past 2 months
• Any medical condition or physical inability to participate in exercise training
• Systolic blood pressure \>160 mmHg
• Diastolic blood pressure \>100 mmHg

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (2)

Koc University Hospital

Istanbul, 34010, Turkey (Türkiye)

Location

Istanbul Medipol University

Istanbul, 34820, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hot Flashes; Motor Activity; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Gizem Yılmaz, RA

  Medipol University

  PRINCIPAL INVESTIGATOR

• Zeliha Candan Algun, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

• Ahmet Fatih Durmuşoğlu, PhD, MD

  Medipol University

  PRINCIPAL INVESTIGATOR

• Sebile Güler Çekiç, PhD, MD

  Koç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 7, 2023
• Study Start: June 15, 2023
• Primary Completion: January 23, 2024
• Study Completion: February 14, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

TU (2)