Multiple Sclerosis, Menstrual Cycle and Physical Acivity

NCT ID: NCT06105463

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2024-12-30

Brief Summary

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Women with Multiple Sclerosis

Women diagnosed with Multiple Sclerosis by a certified neurologist

Group Type: EXPERIMENTAL

Strength training sessions and High-interval intensity training sessions

Intervention Type: OTHER

During strength training sessions, participants will perform 4 lower limb exercises, including bilateral leg press, unilateral leg extension, unilateral hip extension, and bilateral seated calf raise on conventional weight machines. The intensity of the session will be 70-75% of 1-RM, 4 sets, 10 repetitions (1-2 RIR) and 120 seconds rest between sets.

During High-interval intensity training (HIIT) sessions, participants will perform 10 minutes of warm-up at 50% of peak power + 20 minutes of HIIT consisting of 30 seconds at 90% of peak power followed by 30 seconds of rest + 10 minutes of cool-down at 35-40% of peak power in cycloergometer.

Women without Multiple Sclerosis

Women not diagnosed with multiple sclerosis

Group Type: ACTIVE_COMPARATOR

Strength training sessions and High-interval intensity training sessions

Intervention Type: OTHER

During strength training sessions, participants will perform 4 lower limb exercises, including bilateral leg press, unilateral leg extension, unilateral hip extension, and bilateral seated calf raise on conventional weight machines. The intensity of the session will be 70-75% of 1-RM, 4 sets, 10 repetitions (1-2 RIR) and 120 seconds rest between sets.

During High-interval intensity training (HIIT) sessions, participants will perform 10 minutes of warm-up at 50% of peak power + 20 minutes of HIIT consisting of 30 seconds at 90% of peak power followed by 30 seconds of rest + 10 minutes of cool-down at 35-40% of peak power in cycloergometer.

Interventions

Strength training sessions and High-interval intensity training sessions

During strength training sessions, participants will perform 4 lower limb exercises, including bilateral leg press, unilateral leg extension, unilateral hip extension, and bilateral seated calf raise on conventional weight machines. The intensity of the session will be 70-75% of 1-RM, 4 sets, 10 repetitions (1-2 RIR) and 120 seconds rest between sets.

During High-interval intensity training (HIIT) sessions, participants will perform 10 minutes of warm-up at 50% of peak power + 20 minutes of HIIT consisting of 30 seconds at 90% of peak power followed by 30 seconds of rest + 10 minutes of cool-down at 35-40% of peak power in cycloergometer.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Almeria

OTHER

Sponsor Role: lead

Responsible Party

Jacobo Á. Rubio-Arias

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Almeria

Almería, Almeria, Spain

Countries

Spain

References

Rubio-Arias JA, Ramos-Campo DJ, Romero-Parra N, Andreu-Caravaca L, Martinez-Rodriguez A, Esteban-Garcia P, Lopez-Liria R, Molina-Torres G, Ventura-Miranda MI, Martos-Bonilla A, Rando-Martin A, Carrasco-Poyatos M, Alacid F, Ferrer-Contreras MDC, Cupeiro R. Response to physical activity of females with multiple sclerosis throughout the menstrual cycle: a protocol for a randomised crossover trial (EMMA Project). BMJ Open Sport Exerc Med. 2023 Nov 21;9(4):e001797. doi: 10.1136/bmjsem-2023-001797. eCollection 2023.

Reference Type: DERIVED

PMID: 38022757 (View on PubMed)

Other Identifiers

EXP_75066

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UALBIO2022/048

Identifier Type: -

Identifier Source: org_study_id