NCT05400629已完成不适用
Effects of a 12-week Strength Training Program in Women With Myotonic Dystrophy Type 1
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes in maximal isometric muscle strength of the knee extensors
研究概览
简要总结
20 women with myotonic dystrophy type 1 (DM1) will complete a 12-week lower-limb strength training program. The training program consist of 3 series of 6 to 8 maximal repetitions of 5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion. Training sessions will be closely supervise and take place twice a week. It is hypothesize that the training program will induce muscular hypertrophy despite the genetic defect. The training program should also have positive effects on function. The participants will be evaluated at baseline, week 6, week 12, month 6 and month 9 to quantify the effects of the training program and if these effects will be maintained over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Most outcomes will not be mask, however the outcome assessor will be mask for all muscle biopsy analysis: while analysing the muscle biopsy outcomes, the outcome assessor will not know if it was from baseline or from after the training program.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DM1 diagnosis must be confirmed by genetic analysis;
- •Women sex, aged between 30 and 65 years old;
- •Be able to walk without assistance;
- •Consent of the neurologist must be given to participate in this study;
- •Must reside in the Saguenay-Lac-St-Jean region;
- •Subjects must be able to give their consent freely and voluntarily.
排除标准
- •Patients with any other form of muscular dystrophy are excluded;
- •Any contraindication for strenuous exercise or muscle biopsy.
结局指标
主要结局
Changes in maximal isometric muscle strength of the knee extensors
时间窗: At baseline, week 6, week 12, month 3 and month 6
Changes in maximal isometric muscle strength of the knee extensors measure by quantify muscle testing using a handheld dynamometer
次要结局
- Changes in maximal isometric muscle strength of the hip flexors(At baseline and week 12)
- Changes in maximal isometric muscle strength of the hip abductors(At baseline and week 12)
- Changes in the score of the lower extremity functional scale(At baseline, week 12, month 6 and month 9)
- Changes in muscle biopsy of the vastus lateralis: muscle fiber size(At baseline and week 12)
- Changes in the time to perform the Timed stair test(At baseline, week 6, week 12, month 6 and month 9)
- Self-perceived changes in daily life(At week 12)
- Change in blood : biochemical markers (CK, Protein C reactive, leukocytes, cytokines, etc.)(At baseline and week 12)
- Changes in maximal isometric grip strength(At baseline and week 12)
- Changes in 1-repetition maximum strength of the hip abduction exercise(At baseline, week 6 and week 12)
- Changes in comfortable walking speed in the 10-meter walk test(At baseline, week 6, week 12, month 6 and month 9)
- Changes in the score of the myotonic dystrophy health index(At baseline, week 6, week 12, month 6 and month 9)
- Changes in muscle biopsy of the vastus lateralis: muscle proteomics(At baseline and week 12)
- Changes in muscle biopsy of the vastus lateralis: mitochondrial function(At baseline and week 12)
- Changes in muscle biopsy of the vastus lateralis: Nuclear foci(At baseline and week 12)
- Changes in maximal isometric muscle strength of the hip extensors(At baseline and week 12)
- Changes in 1-repetition maximum strength of the leg press exercise(At baseline, week 6 and week 12)
- Changes in 1-repetition maximum strength of the squat exercise(At baseline, week 6 and week 12)
- Changes in the Marin apathy scale(At baseline, week 12, month 6 and month 9)
- Changes in the time to perform of the Timed Up and Go(At baseline, week 6, week 12, month 6 and month 9)
- Change in the score of the Brief Pain Inventory(At baseline, week 6, week 12, month 6 and month 9)
- Change in saliva sample : exercise biomarkers (-Omics markers)(At baseline and week 12)
- Change of the center of pressure (COP) measure in static posturography : closed eyes bipodal position(At baseline, week 6, week 12, 6 months and 9 months)
- Change of the center of pressure (COP) measure in static posturography : open eyes semi-tandem position(At baseline, week 6, week 12, 6 months and 9 months)
- Change of the center of pressure (COP) measure in static posturography : open eyes tandem position(At baseline, week 6, week 12, 6 months and 9 months)
- Changes in maximal isometric muscle strength of the knee flexors(At baseline and week 12)
- Changes in maximal walking speed in the 10-meter walk test(At baseline, week 6, week 12, month 6 and month 9)
- Changes in 1-repetition maximum strength of the leg extension exercise(At baseline, week 6 and week 12)
- Changes in muscle biopsy of the vastus lateralis: muscle fiber typing(At baseline and week 12)
- Changes in muscle biopsy of the vastus lateralis: muscle transcriptomics(At baseline and week 12)
- Changes in the number of repetitions in the 30-seconds sit-to-stand test(At baseline, week 6, week 12, month 6 and month 9)
- Changes in maximal isometric muscle strength of the ankle dorsiflexors(At baseline and week 12)
- Changes in the score of the Fatigue and Daytime Sleepiness Scale(At baseline, week 6, week 12, month 6 and month 9)
- Changes in the Hospital Anxiety and Depression Scale(At baseline, week 6, week 12 and month 6)
- Change in the number of falls(At baseline, week 12, month 6 ans month 9)
- Change in score of the DM1-Activ questionnaire(At baseline, week 6, week 12, month 6 ans month 9)
- Change in urine sample : exercise biomarkers (-Omics markers)(At baseline and week 12)
- Change of the center of pressure (COP) measure in static posturography : open eyes bipodal position(At baseline, week 6, week 12, 6 months and 9 months)
研究者
Élise Duchesne
Professor Investigator
Université de Sherbrooke
研究点 (2)
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