Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Satisfaction with Physical Activity
研究概览
简要总结
This phase of the project aims to compare in-person, supervised educational programs (EP) with online self-guided EPs in individuals with relapsing-remitting multiple sclerosis. A total of 75 participants will be randomly assigned to one of three groups: a supervised and individualized educational program focused on HIIT training, a supervised and individualized educational program focused on strength training, and a non-supervised, self-guided educational program based on resistance band training. Additionally, sessions on the Mediterranean diet (both supervised and non-supervised) and cognitive-behavioral interventions will be included. A control evaluation will be conducted three months after the intervention to assess the effects of the educational programs, followed by another evaluation three months later to analyze residual effects. Women who participated in Phase 1 of the study will be invited to take part in this second phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men of reproductive age (18-45 years) with MS will be included, with the upper age limit adjusted to reflect the reproductive phase;
- •no iron-deficiency anemia;
- •stable disease phase;
- •independent walking ability for over 10 meters.
- •Women will be recruited first and later matched with men based on age, EDSS, and lifestyle habits (physical activity, smoking, and alcohol consumption).
排除标准
- •will include participants with MS who:
- •score <1 or >6 on the EDSS;
- •report a relapse within 12 months before the study begins;
- •have taken corticosteroid treatment within the last 2 months;
- •have participated in a structured training program in the previous 6 months.
- •Once all women with MS are recruited, male participants will be recruited following a 1:1 matching methodology based on age, geographic region, and lifestyle habits.
研究组 & 干预措施
Supervised Strength Training Program (PE1)
Participants will complete 36 strength sessions (3 times a week) at a moderate intensity, 6 educational nutritional intervention sessions, and 8 sessions on energy and fatigue management.
干预措施: Strength training, nutrition, and behavioral training (Other)
Self-Guided and Unsupervised Program with General Recommendations (PE1)
Participants will be involved in an unsupervised, self-directed program focusing on physical exercise (three times per week), nutrition and cognitive-behavioral habits.
干预措施: Self-Guided and Unsupervised Program with General Recommendations (Other)
结局指标
主要结局
Satisfaction with Physical Activity
时间窗: Immediately after the intervention
Satisfaction with Physical Activity will be measured using an eight-item, 5-point Likert scale
Visual Analogue Scale for Fatigue (VAS-F)
时间窗: Immediately after each of the 36 exercise sessions (post-session assessment).
The Visual Analogue Scale for Fatigue (VAS-F) assesses subjective levels of fatigue and energy
Modified Fatigue Impact Scale (MFIS)
时间窗: 48 hours after the last exercise session (post-intervention assessment).
Fatigue perception will be measured using the MFIS. This scale is a 21-item multidimensional questionnaire that evaluates the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84)
Satisfaction with Physical Activity
时间窗: Baseline (pre-intervention)
Satisfaction with Physical Activity will be measured using an eight-item, 5-point Likert scale
Visual Analogue Scale for Fatigue (VAS-F)
时间窗: Immediately before each of the 36 exercise sessions (pre-session assessment).
The Visual Analogue Scale for Fatigue (VAS-F) assesses subjective levels of fatigue and energy
Modified Fatigue Impact Scale (MFIS)
时间窗: Baseline (pre-intervention).
Fatigue perception will be measured using the MFIS. This scale is a 21-item multidimensional questionnaire that evaluates the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84).
次要结局
- Fatigue Visual Analog Scale (VAS-F)(Immediately after each physical exercise session (post-intervention assessment).)
- Inflammatory Profile(48 hours after the last exercise session (post-intervention assessment).)
- The hormonal profile(Pre-intervention in each phase of the menstrual cycle (early follicular phase, late follicular phase and mid-luteal phase).)
- Cognitive Function(48 hours after the last exercise session (post-intervention assessment).)
- Neurofilament Light Chain (NFL)(48 hours after the last exercise session (post-intervention assessment).)
- Physical Self-Perception(48 hours after the last exercise session (post-intervention assessment).)
- Walking Endurance(48 hours after the last exercise session (post-intervention assessment).)
- Pain Catastrophizing(48 hours after the last exercise session (post-intervention assessment).)
- Quality of Life questionnaire(48 hours after the last exercise session (post-intervention assessment).)
- State-Trait Anxiety(48 hours after the last exercise session (post-intervention assessment).)
- Anthropometric(48 hours after the last exercise session (post-intervention assessment).)
- Rate of force development(48 hours after the last exercise session (post-intervention assessment).)
- Bioimpedance(48 hours after the last exercise session (post-intervention assessment).)
- Maximum Voluntary Isometric Contraction(48 hours after the last exercise session (post-intervention assessment).)
- Maximal neural drive(48 hours after the last exercise session (post-intervention assessment).)
- Upper Limb Maximum Strength(48 hours after the last exercise session (post-intervention assessment).)
- Spasticity(48 hours after the last exercise session (post-intervention assessment).)
- Intrinsic muscle characteristics(48 hours after the last exercise session (post-intervention assessment).)
- Gait speed(48 hours after the last exercise session (post-intervention assessment).)
- Static balance with eyes open(48 hours after the last exercise session (post-intervention assessment).)
- Static balance with eyes closed(48 hours after the last exercise session (post-intervention assessment).)
- Sit-to-stand(48 hours after the last exercise session (post-intervention assessment).)
- Timed Up-and-Go test(48 hours after the last exercise session (post-intervention assessment).)
- Delayed onset muscle soreness(Immediately after each physical exercise session (post-intervention assessment).)
- Subjective Perception of Effort(Immediately after each physical exercise session (post-intervention assessment).)
- Inflammatory Profile(Baseline (pre-intervention).)
- Cognitive Function(Baseline (pre-intervention).)
- Neurofilament Light Chain (NFL)(Baseline (pre-intervention).)
- Physical Self-Perception(Baseline (pre-intervention).)
- Walking Endurance(Baseline (pre-intervention).)
- Pain Catastrophizing(Baseline (pre-intervention).)
- Quality of Life questionnaire(Baseline (pre-intervention).)
- State-Trait Anxiety(Baseline (pre-intervention).)
- Rate of force development(Baseline (pre-intervention).)
- Maximum Voluntary Isometric Contraction(Baseline (pre-intervention).)
- Maximal neural drive(Baseline (pre-intervention).)
- Central activation ratio(Baseline (pre-intervention).)
- Upper Limb Maximum Strength(Baseline (pre-intervention).)
- Spasticity(Before the first session of the intervention program)
- Intrinsic muscle characteristics(Baseline (pre-intervention).)
- Gait speed(Baseline (pre-intervention).)
- Static balance with eyes open(Baseline (pre-intervention).)
- Static balance with eyes closed(Baseline (pre-intervention).)
- Sit-to-stand(Baseline (pre-intervention).)
- Timed Up-and-Go test(Baseline (pre-intervention).)
- Delayed onset muscle soreness(Baseline (pre-intervention).)
- Subjective Perception of Effort(Baseline (pre-intervention).)
- Fatigue Visual Analog Scale (VAS-F)(Baseline (pre-intervention).)
- Anthropometric(Baseline (pre-intervention).)
- Bioimpedance(Baseline (pre-intervention).)
- Physical Activity Levels(Baseline (pre-intervention).)
- Dietary and Nutritional Follow-up(Baseline (pre-intervention).)
- The Kurtzke Disability Scale(Baseline (pre-intervention).)
- Subjective Sleep Quality Questionnaire(Baseline (pre-intervention).)
- Sleep Quality Measured by Actigraph(The week prior to the start of the intervention. Baseline (pre-intervention).)
- Central activation ratio(48 hours after the last exercise session (post-intervention assessment).)
- Physical Activity Levels(48 hours after the last exercise session (post-intervention assessment).)
- Dietary and Nutritional Follow-up(48 hours after the last exercise session (post-intervention assessment).)
- The Kurtzke Disability Scale(48 hours after the last exercise session (post-intervention assessment).)
- Subjective Sleep Quality Questionnaire(48 hours after the last exercise session (post-intervention assessment).)
- Sleep Quality Measured by Actigraph(The week following the completion of the intervention (post-intervention assessment).)
研究者
Jacobo Á. Rubio-Arias
Principal Investigator
Universidad de Almeria