Multiple Sclerosis, Menstrual Cycle and Physical Acivity

NCT06105463 | Completed DMC

• 2 other identifiers: UALBIO2022/048EXP_75066
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

strength training; High-Intensity Interval Training; Physical activity satisfaction; quality of life

Outcome Measures

Primary Outcomes (10)

• Satisfaction with physical activity

  Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.

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

• Satisfaction with physical activity

  Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.

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

• Satisfaction with physical activity

  Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.

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

• Satisfaction with physical activity

  Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.

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

• Satisfaction with physical activity

  Satisfaction with physical activity will be assessed using an eight-item scale adapted from previous studies. The questionnaire begins with the statement "When I am doing physical activity" followed by the items "I am satisfied with the results of/I am satisfied with/I enjoy/I feel good when I have done/I notice positive results if I have done physical activity," "Physical activity has many advantages," and "I find physical activity nice/difficult." Responses to this single-item question will be measured on a 5-point scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Satisfaction will be assessed before, immediately following the training session, and at 24, 48, and 72 hours.

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

• Visual analog scale of fatigue (VAS-F)

  This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.

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

• Visual analog scale of fatigue (VAS-F)

  This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.

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

• Visual analog scale of fatigue (VAS-F)

  This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.

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

• Visual analog scale of fatigue (VAS-F)

  This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.

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

• Visual analog scale of fatigue (VAS-F)

  This scale is subdivided into two subscales: fatigue and energy. The VAS-F presents a horizontal line measuring 100mm in length, with the term "none" at one end and "very severe" at the opposite end. Participants are required to mark the point on the line that corresponds to their perception of fatigue severity between these two endpoints. The fatigue subscale is organized starting from the most positive items to the most negative ones. Conversely, the energy subscale ranges from the most negative to the most positive items. A high score on the VAS-F indicates a low score on the energy subscale and a high level of severity on the fatigue subscale. This scale is widely used both in the general population and in clinical patients due to its brevity, ease of use, and comprehensibility.

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

Secondary Outcomes (66)

• Subjective Sleep Quality Questionnaire

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

• Subjective Sleep Quality Questionnaire

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

• Subjective Sleep Quality Questionnaire

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

• Subjective Sleep Quality Questionnaire

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

• Subjective Sleep Quality Questionnaire

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

Study Arms (2)

Women with Multiple Sclerosis

EXPERIMENTAL

Women diagnosed with Multiple Sclerosis by a certified neurologist

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

Women without Multiple Sclerosis

ACTIVE COMPARATOR

Women not diagnosed with multiple sclerosis

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

Interventions

Strength training sessions and High-interval intensity training sessions 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 with Multiple Sclerosis; Women without Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

University of Almeria

Almería, Almeria, 04120, Spain

Location

Related Publications (1)

• 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.

  PMID: 38022757 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: An randomized crossover trial and single-blind.

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 27, 2023
• Study Start: May 6, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

ES (1)