Effects of Diaphragmatic Breathing Exercises Combined With Diaphragmatic Electrostimulation Using KOTS Currents in Patients With Long COVID: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Forced Vital Capacity
研究概览
简要总结
This study will evaluate the effects of diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents in patients with Long COVID. Participants will be randomly assigned to one of two groups. The control group will perform diaphragmatic breathing exercises, while the intervention group will perform diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents. The intervention will last three weeks, with two sessions per week. The study will assess respiratory function, quality of life, physical function, dyspnea, fatigue, and basal oxygen saturation.
详细描述
Long COVID is a multifactorial condition that may be associated with persistent respiratory symptoms, reduced physical capacity, fatigue, dyspnea, and impaired quality of life. Respiratory rehabilitation strategies may contribute to improving breathing patterns and functional recovery in this population. Diaphragmatic breathing exercises are commonly used to promote respiratory control and diaphragmatic activation. In addition, KOTS currents, also known as Russian currents, are medium-frequency alternating currents used in physiotherapy to elicit muscle contraction and may be applied as a complementary strategy to stimulate the diaphragm.
This pilot randomized controlled trial will compare diaphragmatic breathing exercises alone with diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents in patients diagnosed with Long COVID. Participants will be randomly allocated to either the control group or the intervention group. Both groups will receive a three-week intervention consisting of two sessions per week. The control group will perform diaphragmatic breathing exercises, whereas the intervention group will perform the same breathing exercises combined with diaphragmatic electrostimulation.
Assessments will be conducted before and after the intervention period. The study is intended to explore whether adding diaphragmatic electrostimulation to a respiratory exercise program may provide additional benefits compared with diaphragmatic breathing exercises alone in this population.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (结局评估者)
盲法说明
The outcomes assessor was masked to group allocation. Participants were assigned to either diaphragmatic breathing exercises alone or diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Men and women aged 18 to 65 years.
- Medical diagnosis of Long COVID.
- At least 2 months since SARS-CoV-2 infection.
- Ability and willingness to provide informed consent.
- Ability to participate in the assigned intervention and assessment procedures.
排除标准
- Presence of a pacemaker.
- History of epilepsy.
- Pregnancy.
- History of acute cardiac arrest.
- Severe respiratory distress.
- Use of a wheelchair.
- Blurred vision.
- Cyanosis.
- Refusal to perform part or all of the treatment.
- Incomplete or incorrectly completed questionnaires.
研究组 & 干预措施
Diaphragmatic Breathing Exercises Plus KOTS Currents
Participants assigned to this arm will perform diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents. The intervention will be delivered twice per week for three weeks. KOTS currents will be applied as medium-frequency alternating current stimulation, with stimulation intensity adjusted according to participant tolerance.
干预措施: Diaphragmatic Breathing Exercises (Behavioral)
Diaphragmatic Breathing Exercises Plus KOTS Currents
Participants assigned to this arm will perform diaphragmatic breathing exercises combined with diaphragmatic electrostimulation using KOTS currents. The intervention will be delivered twice per week for three weeks. KOTS currents will be applied as medium-frequency alternating current stimulation, with stimulation intensity adjusted according to participant tolerance.
干预措施: Diaphragmatic Electrostimulation Using KOTS Currents (Device)
Diaphragmatic Breathing Exercises
Participants assigned to this arm will perform diaphragmatic breathing exercises twice per week for three weeks. Exercises will be performed in a supine position, with slow nasal inspiration and abdominal expansion followed by slow exhalation through pursed lips.
干预措施: Diaphragmatic Breathing Exercises (Behavioral)
结局指标
主要结局
Forced Vital Capacity
时间窗: Baseline and 3 weeks
Forced vital capacity will be assessed using spirometry. The outcome will evaluate the change in forced vital capacity from baseline to after the three-week intervention.
次要结局
- Forced Expiratory Volume in One Second(Baseline and 3 weeks)
- Peak Expiratory Flow(Baseline and 3 weeks)
- FEV1/FVC Ratio(Baseline and 3 weeks)
- Basal Oxygen Saturation(Baseline and 3 weeks)
- Physical Function(Baseline and 3 weeks)
- Dyspnea(Baseline and 3 weeks)
- Quality of Life with SF-36 questionnaire(Baseline and 3 weeks)
- Fatigue(Baseline and 3 weeks)
研究者
Sara Perpiñá
Principal investigator and Professor of Physiotherapy
Universidad Pontificia de Salamanca
研究点 (1)
标识符
- NCT 编号
- NCT07621588
- 其他研究编号
- UPSA-KOTS-LC-2025
日期
- 首次提交
- (4个月前)
- 首次发布
- (4个月前)
- 主要完成日期
- (2个月前)
- 研究完成日期
- (上个月)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Individual participant data will not be shared because the study involves health-related data from a small sample of participants. Data will be pseudonymized and handled in accordance with applicable data protection regulations and the informed consent approved for the study.