Clinical trial NCT06105463: Multiple Sclerosis, Menstrual Cycle and Physical Acivity
Official title: Response to Physical Activity in Women with Multiple Sclerosis Throughout the Menstrual Cycle (EMMA Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: strength training
High-Intensity Interval Training
Physical activity satisfaction
quality of life
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Intervention model description: An randomized crossover trial and single-blind.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Satisfaction with physical activity
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Satisfaction with physical activity
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Satisfaction with physical activity
timeFrame: 24 hours after sessions (strength and High-interval intensity training session)
measure: Satisfaction with physical activity
timeFrame: 48 hours after sessions (strength and High-interval intensity training session)
measure: Satisfaction with physical activity
timeFrame: 72 hours after sessions (strength and High-interval intensity training session)
measure: Visual analog scale of fatigue (VAS-F)
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Visual analog scale of fatigue (VAS-F)
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Visual analog scale of fatigue (VAS-F)
timeFrame: 24 hours after sessions (strength and High-interval intensity training session)
measure: Visual analog scale of fatigue (VAS-F)
timeFrame: 48 hours after sessions (strength and High-interval intensity training session)
measure: Visual analog scale of fatigue (VAS-F)
timeFrame: 72 hours after sessions (strength and High-interval intensity training session)
Secondary outcomes:
measure: Subjective Sleep Quality Questionnaire
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Subjective Sleep Quality Questionnaire
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Subjective Sleep Quality Questionnaire
timeFrame: 24 hours after sessions (strength and High-interval intensity training session)
measure: Subjective Sleep Quality Questionnaire
timeFrame: 48 hours after sessions (strength and High-interval intensity training session)
measure: Subjective Sleep Quality Questionnaire
timeFrame: 72 hours after sessions (strength and High-interval intensity training session)
measure: Sleep Quality Measured by Actigraphy
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Sleep Quality Measured by Actigraphy
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Sleep Quality Measured by Actigraphy
timeFrame: 24 hours after sessions (strength and High-interval intensity training session)
measure: Sleep Quality Measured by Actigraphy
timeFrame: 48 hours after sessions (strength and High-interval intensity training session)
measure: Sleep Quality Measured by Actigraphy
timeFrame: 72 hours after sessions (strength and High-interval intensity training session)
measure: Heart Rate Variability
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Heart Rate Variability
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Heart Rate Variability
timeFrame: 24 hours after sessions (strength and High-interval intensity training session)
measure: Heart Rate Variability
timeFrame: 48 hours after sessions (strength and High-interval intensity training session)
measure: Heart Rate Variability
timeFrame: 72 hours after sessions (strength and High-interval intensity training session)
measure: Heart Rate Variability
timeFrame: During sessions (strength and High-interval intensity training session)
measure: Muscle oxygen saturation
timeFrame: During sessions (strength and High-interval intensity training session)
measure: Lactate
timeFrame: During sessions (strength and High-interval intensity training session)
measure: Maximum oxygen consumption
timeFrame: During sessions (strength and High-interval intensity training session)
measure: Body composition
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Body composition
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Hormonal profile
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Hormonal profile
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Inflammatory profile
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Inflammatory profile
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Cognitive function
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Cognitive function
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Rate of force development
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Rate of force development
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Maximal Voluntary Activation
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Maximal Voluntary Activation
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Contractile properties of muscle
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Contractile properties of muscle
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Central activation ratio
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Central activation ratio
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Maximal upper limb strength
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Maximal upper limb strength
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Spasticity
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Spasticity
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Gait speed
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Gait speed
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Balance
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Balance
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Sit-to-Stand Test (STS)
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Sit-to-Stand Test (STS)
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Timed Up and Go Test (TUG)
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Timed Up and Go Test (TUG)
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Rating of Perceived Exertion (RPE)
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Rating of Perceived Exertion (RPE)
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Delayed-Onset Muscle Soreness (DOMS)
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Delayed-Onset Muscle Soreness (DOMS)
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Muscle pain sensitivity
timeFrame: Before sessions (strength and High-interval intensity training session)
measure: Muscle pain sensitivity
timeFrame: Immediately after sessions (strength and High-interval intensity training session)
measure: Fat mass
timeFrame: Baseline Measurements
measure: Muscle mass
timeFrame: Baseline Measurements
measure: Bone mass
timeFrame: Baseline Measurements
measure: Dietary and nutritional monitoring
timeFrame: Baseline Measurements
measure: Physical activity levels
timeFrame: Baseline measurements
measure: Physical activity levels
timeFrame: 7 days after the end of the study
measure: Walking endurance
timeFrame: Baseline measurements
measure: Physical self-perception
timeFrame: Through study completion, an average of 3 times per month, up to 10 weeks.
measure: Catastrophizing Pain Scale
timeFrame: Through study completion, an average of 3 times per month, up to 10 weeks.
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Through study completion, an average of 3 times per month, up to 10 weeks.
measure: Multiple Sclerosis Quality of Life-54 (MSQoL-54)
timeFrame: Through study completion, an average of 3 times per month, up to 10 weeks.
measure: State anxiety and trait anxiety (STAI)
timeFrame: Through study completion, an average of 3 times per month, up to 10 weeks.
measure: Body temperature
timeFrame: Through study completion, an average of 3 times per month, up to 10 weeks.
Other outcomes:
Locations:
city: Almería
country: Spain
facility: University of Almeria
state: Almeria
Study officials:
References: