Effects of Strength Training on the Gait and Pelvic Floor in Menopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pelvic Floor Muscle Activity During Gait
研究概览
简要总结
The overall objective will be to observe whether a strength and balance training intervention produces significant changes in the analysis of double stance phase movement during gait, the analysis of coxofemoral, tibial and calcaneal joint movement during gait, pelvic floor contractile activity in standing and monopodal stability, stress urinary incontinence, fracture risk, sexual function and prolapse in sedentary menopausal women in the short and medium term.
详细描述
A prospective experimental study will be conducted. A single-blind, randomised controlled clinical trial.
The study subjects will be selected voluntarily and will meet the inclusion criteria of the study. The sample will be recruited through social networks (Instagram, twitter, facebook), messaging applications (whatsapp, tiami, lex), public and private gynaecology consultations in different health centres and women's associations.
Women over 45 and under 77 years of age in the menopausal period (minimum 12 months of amenorrhoea) who have read the information sheet, completed the informed consent form and met the following inclusion criteria will participate in the study:
A prospective experimental study will be conducted. A single-blind, randomised controlled clinical trial.
The study subjects will be selected voluntarily and will meet the inclusion criteria of the study. The sample will be recruited through social networks (Instagram, twitter, facebook), messaging applications (whatsapp, tiami, lex), public and private gynaecology consultations in different health centres and women's associations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
盲法说明
At the end of the PI's assessment, they will be contacted by researcher 1 who will randomly assign participants to either the intervention or control group.
入排标准
- 年龄范围
- 45 Years 至 77 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women over 45 years of age and under 77 years of age in menopausal period (minimum 12 months of amenorrhea) who have read the information sheet, completed the informed consent and meet the following inclusion criteria will participate in the study:
- •Sedentary lifestyle described as less than 30 minutes per day of regular exercise and less than 3 days per week according to the WHO definition of regular physical activity.
- •Availability to participate in the study and to attend all the scheduled sessions.
- •Be able to read and write and have a command of the spoken and written Spanish language.
- •Have a diagnosis of urinary incontinence and/or pelvic organ prolapse and/or sexual dysfunction.
排除标准
- •Systemic disease Cardiovascular disease Vestibular and/or visual pathology including clinical symptoms of vertigo, tinnitus, hypoacusis and/or aural tinnitus History of psychiatric illness Cognitive deficits for any reason Neurological injury Walking aids, orthoses or prostheses Ingestion of vestibular sedatives or other central nervous system depressants Musculoskeletal diseases with lower limb deformity Lower limb surgery within the last 10 years Urogenital surgery Latex allergy
研究组 & 干预措施
Sequence A (Strength Training first)
You will attend the assessments, complete the surveys and carry out the intervention.
Participants in the intervention group will be scheduled two days a week for two guided sessions of live online training supervised and guided by a person trained and graduated in CCAFyD/Physiotherapy. In short, there will be two 45-60 minute sessions per week for three months in the case of the intervention group.
干预措施: Strength training (Other)
Sequence B (Control first)
They will attend the assessments and complete the surveys. The control group will not undertake any training sessions, only the same assessments as the intervention group.
干预措施: Strength training (Other)
结局指标
主要结局
Pelvic Floor Muscle Activity During Gait
时间窗: Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention)
Mean root mean square (RMS) amplitude of the EMG signal of pelvic floor muscles recorded during 90 seconds of steady-state walking at self-selected speed using intracavitary electromyography (Mdurance®). Signals will be band-pass filtered (10-480 Hz), rectified, and processed using RMS.
次要结局
- Gait Kinematics(Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention))
- Plantar Pressure Distribution(Baseline, Week 12 (post-intervention), Week 16 (1-month post-intervention), and Week 24 (3-months post-intervention))
研究者
Ester Cerezo-Téllez
Principal Investigator, Clinical Professor
University of Alcala