Response to Physical Activity in Women with Multiple Sclerosis Throughout the Menstrual Cycle (EMMA Project)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Universidad de Almeria
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Visual analog scale of fatigue (VAS-F)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Jacobo Á. Rubio-Arias
Associate Professor
Universidad de Almeria
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
Outcomes
Primary Outcomes
Visual analog scale of fatigue (VAS-F)
Time Frame: 72 hours after sessions (strength and High-interval intensity training session)
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.
Satisfaction with physical activity
Time Frame: 72 hours after sessions (strength and High-interval intensity training session)
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.
Secondary Outcomes
- Delayed-Onset Muscle Soreness (DOMS)(Immediately after sessions (strength and High-interval intensity training session))
- Timed Up and Go Test (TUG)(Immediately after sessions (strength and High-interval intensity training session))
- Sleep Quality Measured by Actigraphy(72 hours after sessions (strength and High-interval intensity training session))
- Maximum oxygen consumption(During sessions (strength and High-interval intensity training session))
- Lactate(During sessions (strength and High-interval intensity training session))
- Body composition(Immediately after sessions (strength and High-interval intensity training session))
- Rate of force development(Immediately after sessions (strength and High-interval intensity training session))
- Central activation ratio(Immediately after sessions (strength and High-interval intensity training session))
- Spasticity(Immediately after sessions (strength and High-interval intensity training session))
- Sit-to-Stand Test (STS)(Immediately after sessions (strength and High-interval intensity training session))
- Rating of Perceived Exertion (RPE)(Immediately after sessions (strength and High-interval intensity training session))
- Subjective Sleep Quality Questionnaire(72 hours after sessions (strength and High-interval intensity training session))
- Cognitive function(Immediately after sessions (strength and High-interval intensity training session))
- Bone mass(Baseline Measurements)
- Heart Rate Variability(During sessions (strength and High-interval intensity training session))
- Muscle oxygen saturation(During sessions (strength and High-interval intensity training session))
- Hormonal profile(Immediately after sessions (strength and High-interval intensity training session))
- Inflammatory profile(Immediately after sessions (strength and High-interval intensity training session))
- Maximal Voluntary Activation(Immediately after sessions (strength and High-interval intensity training session))
- Maximal upper limb strength(Immediately after sessions (strength and High-interval intensity training session))
- Gait speed(Immediately after sessions (strength and High-interval intensity training session))
- Contractile properties of muscle(Immediately after sessions (strength and High-interval intensity training session))
- Fat mass(Baseline Measurements)
- Body temperature(Through study completion, an average of 3 times per month, up to 10 weeks.)
- Balance(Immediately after sessions (strength and High-interval intensity training session))
- Muscle mass(Baseline Measurements)
- Dietary and nutritional monitoring(Baseline Measurements)
- Physical self-perception(Through study completion, an average of 3 times per month, up to 10 weeks.)
- Modified Fatigue Impact Scale (MFIS)(Through study completion, an average of 3 times per month, up to 10 weeks.)
- Multiple Sclerosis Quality of Life-54 (MSQoL-54)(Through study completion, an average of 3 times per month, up to 10 weeks.)
- Muscle pain sensitivity(Immediately after sessions (strength and High-interval intensity training session))
- Physical activity levels(7 days after the end of the study)
- Walking endurance(Baseline measurements)
- Catastrophizing Pain Scale(Through study completion, an average of 3 times per month, up to 10 weeks.)
- State anxiety and trait anxiety (STAI)(Through study completion, an average of 3 times per month, up to 10 weeks.)