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MenopauseWOMEN-EX-MODNCT06533982

Effect of Different Exercise Modalities on Cardiovascular and Cognitive Response in Postmenopausal Women

A study testing High intensity interval exercise session and Isometric neuromuscular exercise session in people with Menopause and Blood Pressure, run by University of Poitiers at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Menopause, Blood Pressure, Cognitive Decline
What is being tested?
High intensity interval exercise session and Isometric neuromuscular exercise session
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
10 Mar 2023to 20 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Faculty of Sport Science - MOVE Laboratory (UR20296)

    Poitiers, 86000

Other trials in France

About this study

Official title: Effect of Different Exercise Modalities on Cardiovascular and Cognitive Response in Postmenopausal Women With and Without Vasomotor Symptoms

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.

Read the detailed description

Menopause is a natural stage in the female aging process, resulting in increased cardiometabolic risk, making cardio-neuro-vascular disease (CNVD) the leading cause of female mortality worldwide after the age of 60. Indeed, falling ovarian hormone concentrations are associated with altered body composition, increased blood pressure, as well as mild cognitive impairment.

For some women, menopause is also accompanied by symptoms that have a significant impact on their quality of life. Among these, menopausal vasomotor symptoms (VMS - hot flushes, night sweats...) are the most frequent, affecting 60% to 80% of women for an average of 5 to 10 years. Several studies have highlighted an altered cardiovascular profile (dyslipidemia, insulin resistance, pre-hypertension/hypertension...) and a more marked decline in cognitive performance in women with VMS.

In order to reduce the risk of CNVD and limit cognitive impairment, physical exercise appears to be a particularly interesting non-pharmacological management option for postmenopausal women. Indeed, the latter seem to present a 10-year post-menopausal time window, during which physical activity has a positive vascular and probably neurovascular effect, although the latter remains to be demonstrated. Numerous studies have also shown that physical activity is associated with a lower rate of cognitive decline, and improved quality of life.

However, to date, there is little evidence to determine which exercise modalities are most effective in managing the risk of CNVD in postmenopausal women.

The aims of this study:

  • To examine the effect of exercise on markers of cardio-neuro-vascular health and cognition in postmenopausal women.
  • Second, to compare the differences in the cardio-neuro-vascular and cognitive response to exercise, dependent on the type of exercise, the physical fitness and the presence of menopausal symptoms.
  • Third, to examine the effect of menopausal symptoms, and physical fitness on cardio-neuro-vascular health markers and cognitive health markers.
Being tested
High intensity interval exercise session, Isometric neuromuscular exercise session
Keywords
Physical exercise, High intensity interval exercise, Handgrip
Medical subject headings
Cognitive Dysfunction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High intensity interval exercise sessionOther

    Physical activity session supervised and adapted on ergometer

  • Isometric neuromuscular exercise sessionOther

    Physical activity session supervised and adapted with a handgrip

Study groups in NCT06533982
Study groupRoleWhat they receive
High intensity interval exercise sessionExperimentalPerformed 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.
Receives: Other: High intensity interval exercise session
Isometric neuromuscular exercise sessionExperimentalPerformed 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.
Receives: Other: Isometric neuromuscular exercise session
Control sessionNo interventionParticipants are seated for 30 minutes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic and diastolic blood pressure (ambulatory blood pressure measurement)

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

    Measured: After sessions (24 hours)

  2. Systolic and diastolic blood pressure (resting)

    Automated oscillometric tensiometer (mmHg).

    Measured: Before and after sessions (15 minutes)

Secondary outcomes (25)
  1. Concentration of cerebral oxygenation

    Near-infrared spectroscopy is used to measure concentrations of oxygenated and desoxygenated hemoglobin (µmol/L).

    Measured: Before, during, and after sessions (1 hour)

  2. Working memory

    2-back task (scored from 0 to 28, higher scores indicate better working memory).

    Measured: Before and after sessions (10 minutes)

  3. Episodic memory

    Memory scale III (MEM-III), a story recall task taken from the test battery in the Wechsler-Memory Scale-Revised (scored from 0 to 25, higher scores indicate better episodic memory).

    Measured: Before and after sessions (15 minutes)

  4. Executive function

    Stroop task, used to assess inhibitory control (scored as a ratio, negative score indicates worse inhibitory control vs. positive score indicates better inhibitory control).

    Measured: Before and after sessions (15 minutes)

  5. Perception of exertion

    Modified Borg scale (scored 0 to 10, higher score indicates lower exercise tolerance).

    Measured: After sessions (1 minute)

  6. Endothelial function (brachial artery dilation capacity)

    At rest, the flow-mediated dilatation technique is used with high-resolution Doppler ultrasound (CX-50 Philipps).

    Measured: Baseline (30 minutes)

  7. Baroreflex sensitivity

    At rest, baroreflex sensitivity is measured using the Finapres.

    Measured: Baseline (1 hour)

  8. Aortic systolic and diastolic blood pressure

    At rest, using the SphygmoCor device, which measures central blood pressure (mmHg).

    Measured: Baseline (15 minutes)

  9. Arterial stiffness (pulse wave velocity)

    At rest, using the SphygmoCor device, which calculates carotid-femoral pulse wave velocity (m/s).

    Measured: Baseline (15 minutes)

  10. Physical fitness

    Maximal cardiopulmonary effort test (VO2max).

    Measured: Baseline (30 minutes)

  11. Blood lipid concentrations

    Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides (g/L).

    Measured: Baseline (5 minutes)

  12. Blood hormone concentrations

    Progesterone, 17-beta-estradiol, and follicle-stimulating hormone (ng/L).

    Measured: Baseline (5 minutes)

  13. Body weight

    Total body weight, fat mass, fat-free mass and visceral-fat mass in kilograms using the Tanita impedance scale.

    Measured: Baseline (1 minute)

  14. Body composition

    Percentage of body fat and fat-free mass using the Tanita impedance scale.

    Measured: Baseline (1 minute)

  15. Height

    Height in meters measured with a height gauge.

    Measured: Baseline (1 minute)

  16. Body mass index

    Calculated from total body weight and height (kg/m²).

    Measured: Baseline (1 minute)

  17. Cognitive assessment

    Montreal Cognitive Assessment (MoCA) test (scored from 0 to 30, with higher scores indicating better cognitive function).

    Measured: Baseline (15 minutes)

  18. Menopausal rating scale

    Composed of 11 items rating the severity of menopausal symptoms from 0 (no symptoms) to 4 (very severe).

    Measured: Baseline (15 minutes)

  19. Hot flash related daily interference scale

    Composed of 10 items scored from 0 (no impact) to 10 (completely interferes), evaluating the impact of vasomotor symptoms on daily life.

    Measured: Baseline (15 minutes)

  20. Hospital Anxiety and Depression Scale

    It provides two scores ranging from 0 to 21 that quantify anxiety and depression. Higher scores indicate more severe symptoms.

    Measured: Baseline (15 minutes)

  21. Global physical activity questionnaire

    Physical activity and sedentary time assessed using the Global Physical Activity Questionnaire. Higher scores indicate better physical activity levels (categorized into high, moderate, and low physical activity levels).

    Measured: Baseline (15 minutes)

  22. Daily tobacco and alcohol use

    Use daily or not use.

    Measured: Baseline

  23. Age

    Age, age at menarche and menopause (in years).

    Measured: Baseline

  24. Educational level

    Secondary education, high school graduate, bachelor's degree, master's or doctoral degree.

    Measured: Baseline

  25. Number of children

    Self-reported.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start10 Mar 2023
  3. Primary completion28 Mar 2023
  4. Study completion20 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06533982
Sponsor's protocol ID
WOMEN-EX-MOD
Acronym
WOMEN-EX-MOD
Status last verified
Jul 2024
First submitted
19 Jul 2024
Last updated
1 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30683584
  • 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.

    PubMed 30843880
  • 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.

    PubMed 32910516
  • 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.

    PubMed 25686030
  • 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.

    PubMed 32585222
  • 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.

    PubMed 31077368
  • 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.

    PubMed 25008420
  • 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.

    PubMed 35964395
  • 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.

    PubMed 41273313

Questions about this trial

What is this clinical trial studying?

A study testing High intensity interval exercise session and Isometric neuromuscular exercise session in people with Menopause and Blood Pressure, run by University of Poitiers at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic and diastolic blood pressure (ambulatory blood pressure measurement) (time frame: After sessions (24 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06533982, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.

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