NCT05764031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

March 1, 2023

Last Update Submit

March 10, 2023

Conditions

Menopause

Keywords

MenopauseAerobic exercisePilatesDepressionSleepQuality of life

Outcome Measures

Primary Outcomes (1)

  • Menopause Rating Scale

    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.

    8 weeks

Secondary Outcomes (3)

  • 36-Item Short Form Health Survey

    8 weeks

  • Beck Depression Inventory

    8 weeks

  • Pittsburgh Sleep Quality Index

    8 weeks

Study Arms (2)

Clinical pilates group

EXPERIMENTAL

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

Aerobic exercise group

EXPERIMENTAL

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

Interventions

Clinical pilates exerciseOTHER

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.

Clinical pilates group
Aerobic exerciseOTHER

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.

Aerobic exercise group

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMenopause is defined as the time in a woman's life when there is a decrease in ovarian function and permanent cessation of reproductive function
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27144, Turkey (Türkiye)

Location

Related Publications (8)

  • Greendale GA, Lee NP, Arriola ER. The menopause. Lancet. 1999 Feb 13;353(9152):571-80. doi: 10.1016/S0140-6736(98)05352-5.

    PMID: 10028999RESULT

  • Santoro N, Epperson CN, Mathews SB. Menopausal Symptoms and Their Management. Endocrinol Metab Clin North Am. 2015 Sep;44(3):497-515. doi: 10.1016/j.ecl.2015.05.001.

    PMID: 26316239RESULT

  • Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause - global prevalence, physiology and implications. Nat Rev Endocrinol. 2018 Apr;14(4):199-215. doi: 10.1038/nrendo.2017.180. Epub 2018 Feb 2.

    PMID: 29393299RESULT

  • Stojanovska L, Apostolopoulos V, Polman R, Borkoles E. To exercise, or, not to exercise, during menopause and beyond. Maturitas. 2014 Apr;77(4):318-23. doi: 10.1016/j.maturitas.2014.01.006. Epub 2014 Jan 24.

    PMID: 24548848RESULT

  • Hill DA, Crider M, Hill SR. Hormone Therapy and Other Treatments for Symptoms of Menopause. Am Fam Physician. 2016 Dec 1;94(11):884-889.

    PMID: 27929271RESULT

  • Reed SD, Guthrie KA, Newton KM, Anderson GL, Booth-LaForce C, Caan B, Carpenter JS, Cohen LS, Dunn AL, Ensrud KE, Freeman EW, Hunt JR, Joffe H, Larson JC, Learman LA, Rothenberg R, Seguin RA, Sherman KJ, Sternfeld BS, LaCroix AZ. Menopausal quality of life: RCT of yoga, exercise, and omega-3 supplements. Am J Obstet Gynecol. 2014 Mar;210(3):244.e1-11. doi: 10.1016/j.ajog.2013.11.016. Epub 2013 Nov 8.

    PMID: 24215858RESULT

  • 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.

    PMID: 27707450RESULT

  • 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.

    PMID: 31341450RESULT

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 10, 2023

Study Start

December 16, 2020

Primary Completion

April 20, 2022

Study Completion

July 26, 2022

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations

TU(1)