Multiple Sclerosis, Menstrual Cycle and Physical Acivity (EMMA)

Universidad de Almeria

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Strength training sessions and High-interval intensity training sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT06105463

EXP_75066 (Other Grant/Funding Number)

UALBIO2022/048

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Women with Multiple Sclerosis

Experimental group

Description:

Women diagnosed with Multiple Sclerosis by a certified neurologist

Treatment:

Other: Strength training sessions and High-interval intensity training sessions

Women without Multiple Sclerosis

Active Comparator group

Description:

Women not diagnosed with multiple sclerosis

Treatment:

Other: Strength training sessions and High-interval intensity training sessions