NCT06533982

Brief Summary

Menopause is a natural stage in female aging, increasing cardiometabolic risk and making cardio-neuro-vascular disease (CNVD) the leading cause of mortality in women over 60. Declining ovarian hormones are linked to changes in body composition, increased blood pressure, and mild cognitive impairment. Menopause also often involves significant symptoms like menopausal vasomotor symptoms (VMS), affecting 60-80% of women for 5-10 years. Women with VMS exhibit a worse cardiovascular profile and greater cognitive decline. Physical exercise is a promising non-pharmacological option to reduce CNVD risk and limit cognitive impairment in postmenopausal women, who have a 10-year window post-menopause during which physical activity benefits vascular and possibly neurovascular health. Studies link physical activity to lower cognitive decline and improved quality of life. However, optimal exercise modalities for managing CNVD risk in postmenopausal women remain undetermined.

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 Mar 2023

Shorter than P25 for not_applicable

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

March 10, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

18 days

First QC Date

July 19, 2024

Last Update Submit

July 31, 2024

Conditions

MenopauseBlood PressureCognitive Decline

Keywords

Physical exerciseHigh intensity interval exerciseHandgrip

Outcome Measures

Primary Outcomes (2)

  • Systolic and diastolic blood pressure (ambulatory blood pressure measurement)

    Post-exercise hypotension, using the Mobil-O-Graph (mmHg).

    After sessions (24 hours)

  • Systolic and diastolic blood pressure (resting)

    Automated oscillometric tensiometer (mmHg).

    Before and after sessions (15 minutes)

Secondary Outcomes (25)

  • Concentration of cerebral oxygenation

    Before, during, and after sessions (1 hour)

  • Working memory

    Before and after sessions (10 minutes)

  • Episodic memory

    Before and after sessions (15 minutes)

  • Executive function

    Before and after sessions (15 minutes)

  • Perception of exertion

    After sessions (1 minute)

  • +20 more secondary outcomes

Study Arms (3)

High intensity interval exercise session

EXPERIMENTAL

Performed on an ergometer, the intensity of the session is adapted to the participant's physical capacity, initially assessed by the VO2max test at baseline. The session begins with a 5-minute warm-up at 50% of maximum aerobic power (MAP). The exercise then consists of 2 sets of 12 repetitions of 15 seconds each at 100% of MAP and 15 seconds of passive recovery. 2-minute of passive recovery is recommended between the two sets. The session ends with 5-minute of recovery at 50% of MAP.

Other: High intensity interval exercise session

Isometric neuromuscular exercise session

EXPERIMENTAL

Performed with a handgrip (K-Force grip, KINVENT), the intensity of the session is adapted to the participant's capacity, initially assessed by the isometric maximal voluntary force (MVF) measurement at the beginning of the session. The session consists of 4 repetitions of 2 minutes at 30% of the isometric MVF, separated by 1 minute recovery.

Other: Isometric neuromuscular exercise session

Control session

NO INTERVENTION

Participants are seated for 30 minutes.

Interventions

High intensity interval exercise sessionOTHER

Physical activity session supervised and adapted on ergometer

High intensity interval exercise session
Isometric neuromuscular exercise sessionOTHER

Physical activity session supervised and adapted with a handgrip

Isometric neuromuscular exercise session

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Menopausal women (absence of menstruation for 12 consecutive months) for less than 10 years
  • Women with or without vasomotor symptoms
  • Women covered by the French Social Security system

You may not qualify if:

  • Surgical menopause (oophorectomy)
  • Premature ovarian failure
  • Chronic renal failure
  • Respiratory pathology (unstable asthma, respiratory insufficiency or pulmonary hypertension)
  • Cardiovascular disease (coronary, valvular, hypertrophic, hypertensive, infiltrative, constrictive or rhythmic)
  • Medically treated hypertension
  • Severe obesity (BMI \> 40 kg/m²)
  • Hearing or vision problems that prevent reading or distinguishing colors
  • Recent (\< 1 year) central neurological or psychiatric disorders
  • Moderate to severe cognitive impairment (MoCA \< 18).
  • Judicial protection or guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sport Science - MOVE Laboratory (UR20296)

Poitiers, 86000, France

Location

Related Publications (9)

  • Armas Rojas N, Dobell E, Lacey B, Varona-Perez P, Burrett JA, Lorenzo-Vazquez E, Calderon Martinez M, Sherliker P, Bess Constanten S, Morales Rigau JM, Hernandez Lopez OJ, Martinez Morales MA, Alonso Aloma I, Achiong Estupinan F, Diaz Gonzalez M, Rosquete Munoz N, Cendra Asencio M, Peto R, Emberson J, Duenas Herrera A, Lewington S. Burden of hypertension and associated risks for cardiovascular mortality in Cuba: a prospective cohort study. Lancet Public Health. 2019 Feb;4(2):e107-e115. doi: 10.1016/S2468-2667(18)30210-X. Epub 2019 Jan 23.

    PMID: 30683584BACKGROUND

  • Greendale GA, Sternfeld B, Huang M, Han W, Karvonen-Gutierrez C, Ruppert K, Cauley JA, Finkelstein JS, Jiang SF, Karlamangla AS. Changes in body composition and weight during the menopause transition. JCI Insight. 2019 Mar 7;4(5):e124865. doi: 10.1172/jci.insight.124865. eCollection 2019 Mar 7.

    PMID: 30843880BACKGROUND

  • Boyle CP, Raji CA, Erickson KI, Lopez OL, Becker JT, Gach HM, Kuller LH, Longstreth W Jr, Carmichael OT, Riedel BC, Thompson PM. Estrogen, brain structure, and cognition in postmenopausal women. Hum Brain Mapp. 2021 Jan;42(1):24-35. doi: 10.1002/hbm.25200. Epub 2020 Sep 10.

    PMID: 32910516BACKGROUND

  • Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, Hess R, Joffe H, Kravitz HM, Tepper PG, Thurston RC; Study of Women's Health Across the Nation. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr;175(4):531-9. doi: 10.1001/jamainternmed.2014.8063.

    PMID: 25686030BACKGROUND

  • Zhu D, Chung HF, Dobson AJ, Pandeya N, Anderson DJ, Kuh D, Hardy R, Brunner EJ, Avis NE, Gold EB, El Khoudary SR, Crawford SL, Mishra GD. Vasomotor menopausal symptoms and risk of cardiovascular disease: a pooled analysis of six prospective studies. Am J Obstet Gynecol. 2020 Dec;223(6):898.e1-898.e16. doi: 10.1016/j.ajog.2020.06.039. Epub 2020 Jun 23.

    PMID: 32585222BACKGROUND

  • Gliemann L, Hellsten Y. The exercise timing hypothesis: can exercise training compensate for the reduction in blood vessel function after menopause if timed right? J Physiol. 2019 Oct;597(19):4915-4925. doi: 10.1113/JP277056. Epub 2019 Jun 30.

    PMID: 31077368BACKGROUND

  • Anderson D, Seib C, Rasmussen L. Can physical activity prevent physical and cognitive decline in postmenopausal women? A systematic review of the literature. Maturitas. 2014 Sep;79(1):14-33. doi: 10.1016/j.maturitas.2014.06.010. Epub 2014 Jun 20.

    PMID: 25008420BACKGROUND

  • Hybholt M. Psychological and social health outcomes of physical activity around menopause: A scoping review of research. Maturitas. 2022 Oct;164:88-97. doi: 10.1016/j.maturitas.2022.07.014. Epub 2022 Aug 3.

    PMID: 35964395BACKGROUND

  • Bourvellec ML, Delpech N, Sosner P, Fritel X, Bosquet L, Enea C. Effect of Exercise Modalities on Post-Exercise Hypotension in Normotensive Postmenopausal Women: A Randomized Controlled Trial on Vasomotor Symptoms Influence. Eur J Sport Sci. 2025 Dec;25(12):e70091. doi: 10.1002/ejsc.70091.

    PMID: 41273313DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Laurent Bosquet, Pr

    University of Poitiers - Faculty of Sport Science - MOVE Laboratory (UR20296)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 19, 2024

First Posted

August 1, 2024

Study Start

March 10, 2023

Primary Completion

March 28, 2023

Study Completion

December 20, 2023

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)