Response to Physical Activity in Women With Multiple Sclerosis Throughout the Menstrual Cycle (EMMA Project)

CompletedNot a drug-phase studyMS (type not specified)NCT06105463

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Strength training sessions and High-interval intensity training sessions

What it measured

Main measures

  • Satisfaction with physical activity

    Before sessions (strength and High-interval intensity training session)

    Physical functionQuality of life (reported by participants)
  • Satisfaction with physical activity

    Immediately after sessions (strength and High-interval intensity training session)

    Physical functionQuality of life (reported by participants)
  • Satisfaction with physical activity

    24 hours after sessions (strength and High-interval intensity training session)

    Physical functionQuality of life (reported by participants)
  • Satisfaction with physical activity

    48 hours after sessions (strength and High-interval intensity training session)

    Physical functionQuality of life (reported by participants)
  • Satisfaction with physical activity

    72 hours after sessions (strength and High-interval intensity training session)

    Physical functionQuality of life (reported by participants)
  • Visual analog scale of fatigue (VAS-F)

    Before sessions (strength and High-interval intensity training session)

    Fatigue
  • Visual analog scale of fatigue (VAS-F)

    Immediately after sessions (strength and High-interval intensity training session)

    Fatigue
  • Visual analog scale of fatigue (VAS-F)

    24 hours after sessions (strength and High-interval intensity training session)

    Fatigue
  • Visual analog scale of fatigue (VAS-F)

    48 hours after sessions (strength and High-interval intensity training session)

    Fatigue
  • Visual analog scale of fatigue (VAS-F)

    72 hours after sessions (strength and High-interval intensity training session)

    Fatigue

Other measures (66)

  • Subjective Sleep Quality Questionnaire

    Before sessions (strength and High-interval intensity training session)

    Mood and sleep
  • Subjective Sleep Quality Questionnaire

    Immediately after sessions (strength and High-interval intensity training session)

    Mood and sleep
  • Subjective Sleep Quality Questionnaire

    24 hours after sessions (strength and High-interval intensity training session)

    Mood and sleep
  • Subjective Sleep Quality Questionnaire

    48 hours after sessions (strength and High-interval intensity training session)

    Mood and sleep
  • Subjective Sleep Quality Questionnaire

    72 hours after sessions (strength and High-interval intensity training session)

    Mood and sleep
  • Sleep Quality Measured by Actigraphy

    Before sessions (strength and High-interval intensity training session)

    Mood and sleep
  • Sleep Quality Measured by Actigraphy

    Immediately after sessions (strength and High-interval intensity training session)

    Mood and sleep
  • Sleep Quality Measured by Actigraphy

    24 hours after sessions (strength and High-interval intensity training session)

    Mood and sleep
  • Sleep Quality Measured by Actigraphy

    48 hours after sessions (strength and High-interval intensity training session)

    Mood and sleep
  • Sleep Quality Measured by Actigraphy

    72 hours after sessions (strength and High-interval intensity training session)

    Mood and sleep

Who could take part

MS (type not specified) · 18 to 40

Show the full criteria

Inclusion criteria

* 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

Exclusion criteria

* a score \< 2 or > 6 on the Expanded Disability Status Scale (EDSS); * experienced a relapse in the 12 months prior to enrolment; * received corticosteroid treatment in the previous 2 months; * participated in a structured exercise programme in the past 6 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, * have unrelated diseases to MS

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      May 2024

    2. Main results due

      Nov 2024

    3. Finished

      Dec 2024

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