NCT06105463Completed
Multiple Sclerosis, Menstrual Cycle and Physical Acivity
Response to Physical Activity in Women With Multiple Sclerosis Throughout the Menstrual Cycle (EMMA Project)
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
This study aims to identify moderating variables that modify satisfaction with physical activity practice throughout the menstrual cycle (MC) in women with and without multiple sclerosis (MS) during High-Intensity Interval Training (HIIT) and strength training sessions, and to compare the acute effects of different types of physical activity sessions in women with and without MS. This study used a randomized crossover trial study and single-blind performed by women with MS, matched 1:1 based on age, lifestyle factors and country of residence, with women without MS to analyse the effect of physical activity practise on satisfaction, functionality, fatigue, and inflammatory profile throughout MC. Participants will visit the facilities approximately 10 times (4 preliminary familiarization visits and 6 visits to carry out a physical activity session in each phase of the MC) over a period of 3-4 months. Evaluation will comprise clinical, nutritional and psychological interviews including different variables such as satisfaction on physical activity; visual analogue scale of fatigue; abdominal obesity and anthropometric variables; dietary and nutritional monitoring; bioimpedance analysis; blood profile of hormone, inflammatory and cognitive function blood profile; neuromuscular strength, voluntary activation, and contractile properties; functional assessment (spasticity, knee angles, gait speed, walking endurance, balance, sit-to-stand test, timed up and go test); rating of perceived exertion; pain; muscle oxygen saturation; lactate; heart rate variability; quality of sleep and life; and body temperature. During the luteal phase, women with MS are expected to exhibit different acute responses to HIIT and strength training sessions compared to women without the disease.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 2 Oct 2023
- Start date
- May 2024
- Primary completion date
- Nov 2024
- Lead sponsor
- Universidad de Almeria
- Diseases
- Multiple sclerosis
- NCT number
- NCT06105463
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From May 2024 to the primary completion date, Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- experienced a relapse in the 12 months prior to enrolment;
- received corticosteroid treatment in the previous 2 months;
- secondary amenorrhoea (absence of ≥ 3 consecutive periods despite not being pregnant and having previous menstruation);
- used or currently use hormonal contraceptives for 3 months before recruitment
- reported musculoskeletal or neurological injuries not associated with MS, recent surgical interventions, or pregnancies in the previous year,
Other illness
- have unrelated diseases to MS
Other
- a score \< 2 or \> 6 on the Expanded Disability Status Scale (EDSS);
- participated in a structured exercise programme in the past 6 months;
Who the study is looking for
- women aged between 18-40 years;
- women with a menstrual cycle length of ≥ 21 days and ≤ 35 days of natural menstruation;
- absence of iron deficiency anaemia (serum ferritin \> 20 μg/L, hemoglobin \> 115 μg/L, transferrin saturation \> 16%)
- being in a stable phase of the disease,
- to ambulate autonomously for more than 100 meters
Age in the registry: 18 years to 40 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Almeria Coordinator of this site? Confirm its status | Almería | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.