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The effect of concurrent training and a herbal medicine on menopausal women.

The effect of concurrent training and vitex agnus-castus on menopausal women in psychological, physical aspects, hormonal profile and sexual function: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-87ndrv
Enrollment
Unknown
Registered
2020-03-17
Start date
2019-10-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor Activity

Interventions

Four groups that will compose the study: (1) control group (CG) + placebo with 26 participants
(2) GC + vitex agnus-castus with 26 participants. 1- Control group (CG) + placebo 1 Guidance on maintaining the daily routine as well as monthly calls will be made on the 5th of each month to remind t
2- Control group (GC) + vitex agnus-castus Monthly, the agnus-castus vitex capsule will be offered by a handling pharmacy, and, daily, the participants should take it in a single dose, daily, in the m
3- Intervention group (IG) + placebo with 26 participants. Participants must guarantee a minimum attendance in class (75% attendance) so that they can obtain the real health benefits. The intervention
4- Intervention group (IG) + vitex agnus-castus with 26 participants. Evaluations and interventions will be carried out, which were made by the GI + placebo, the same guidelines and connections will b
Dietary supplement
Other

Sponsors

Univerdade do Estado de Santa Catarina
Lead Sponsor
Univerdade do Estado de Santa Catarina
Collaborator

Eligibility

Sex/Gender
Female
Age
40 Years to 59 Years

Inclusion criteria

Inclusion criteria: Only menopausal women who fit the menopause rating scale and follicle stimulating hormone levels above 25 IU will be included; who have not practiced concurrent training in the three months prior to data collection and who refrain from practicing physical exercises other than intervention during this period.

Exclusion criteria

Exclusion criteria: Women who do not experience menopausal symptoms according to the menopause rating scale and follicle stimulating hormone levels above 25 IUml; those who do not abstain from training during the intervention period; as well as those with a history of neurological and or musculoskeletal diseases; and who have performed aerobic or endurance training in the three months prior to data collection.

Design outcomes

Primary

MeasureTime frame
Follicle stimulating hormone, assessed by blood collection with values above 25 IU ml.

Secondary

MeasureTime frame
Expected outcome 2; in the physical aspects, it is expected that the concurrent training protocol has a positive impact on cardiorespiratory fitness (assessed by means of a treadmill (Embramed atl 2000) in order to perform the submaximal stress test using the modified Bruce protocol, during the performance of the test, expired gases and flow volume will be collected during and analyzed by a calibrated metabolic system (Quark CPET Ergo, Cosmed, Rome, Italy) for the purpose of providing oxygen absorption measures); muscle strength (the Biodex System 4 PRO isokinetic dynamometer (BiodexTM Medical Systems Inc., Shirley, NY) will be used to measure the muscle strength of the lower limbs); body fat (the percentage of body fat (% F) by means of an image, which will be obtained with the aid of a portable ultrasound device (BX-2000, IntelaMetrix Inc., USA); in the lipid profile (a blood collection will be performed to assess triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol) and BMI (by means of body mass (Kg) divided by height square (m2); a stadiometer will be used to check height with zero point at the level and a digital scale from Plenna Wind MEA 07710 will be used to check the mass).;Expected outcome 3; the concurrent training protocol is expected to positively impact sexual function; which will be evaluated by means of a questionnaire, which was constructed and validated in English the Female Sexual Function Index (FSFI) by Rosen et al. (2000), translated into Brazil, validated and culturally adapted by Thiel et al (2008) to evaluate the Female Sexual Function Index (FSFI) in Brazilian women. The concurrent training protocol is expected to have a positive effect on 6 aspects: sexual desire, arousal, vaginal lubrication, orgasm, satisfaction and pain.;Expected outcome 1; the concurrent training protocol is expected to have a positive effect on the mood, anxiety, depression and stress of menopausal women;

Countries

Brazil

Contacts

Public ContactJuliana Klen

Univerdade do Estado de Santa Catarina

jujuaraujoklen@gmail.com+55 48 3664-8629

Outcome results

None listed

Source: REBEC (via WHO ICTRP)