Physical Activity Coaching in Patients with Post-COVID-19. a Randomised Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Change in functional capacity (one-minute sit-to-stand test) from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
研究概览
简要总结
This randomized clinical trial aims to compare the effects of a 12-week behavioral physical activity intervention (i.e., physical activity coaching) with usual care (i.e., World Health Organization recommendations for being physically active) in patients with post-COVID-19 (i.e., patients who suffered from COVID-19 at any degree of severity in acute phase and experience symptoms for at least three months after discharge).
This study aims to answer the following question:
1) Which are the effects of a physical activity coaching intervention compared with usual care in patients post-COVID-19 in the short-, middle- and long-term?
详细描述
Patients will be invited to participate via phone calls, and those interested will be scheduled to obtain their written informed consent and undergo a baseline assessment.
Afterwards, they will be randomized into an experimental group and a control group. In the experimental group, a 12-week/three-month physical activity coaching intervention will be conducted, while the control group will receive usual care. A post-intervention assessment will then be carried out, followed by follow-ups at 6 and 12 months after the baseline assessment.
The assessment will consist of a series of tests and questionnaires to record the following data: physical activity, functional capacity, muscle strength, health-related quality of life, symptoms, lung function, sociodemographic, and anthropometric data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least, 18 years of age.
- •Having been diagnosed of COVID-19, confirmed by a polymerase chain reaction [PCR] test or an antigen test, at one of the severity levels during the acute phase of the illness.
- •Presenting a diagnosis of post-COVID-19, persistent COVID, or long COVID, involving the persistence of symptoms for at least three months after the acute phase of the illness (i.e., to reduce variability in the diagnosis, it is proposed that symptom persistence be for at least 12 months).
- •Being included in a post-COVID-19 follow-up consultation (or another consultation - pulmonology, internal medicine - in the event of closure of a specific consultation) in the region of Madrid, Spain.
- •Stable condition of symptoms and comorbidities (i.e., no major change in clinical status).
排除标准
- •Presenting significant signs of cognitive decline, cardiovascular, neurological, and/or musculoskeletal disease that could hinder the performance of assessment tests and thus limit participation or pose a risk to their health.
- •Particularly presenting the following conditions: cognitive disorders such as sequelae of Alzheimer's disease, senile dementia; comprehension disorders such as Wernicke's aphasia; cognitive-motor disorders such as hemiparesis/hemiplegia due to stroke; musculoskeletal disorders such as non-healed fractures, external prostheses (including prosthetic limbs for amputees); cardiovascular disorders such as unstable angina, recent acute myocardial infarction, among others.
- •Medical history that interferes with the study's objectives or compromises its conclusions.
- •Any health issues that limit life expectancy to less than one year.
- •Medical, social, or geographical factor that may endanger the patient.
- •Psycho-physical inability to complete assessment tests and questionnaires.
研究组 & 干预措施
Physical activity coaching - Experimental group
The experimental group intervention consists of a 12-week physical activity coaching program informed by the literature (CRD42021253066). The intervention is conducted at participants' home or within the community, delivered remotely (mostly) and face-to-face, and encompasses several behaviour change components (mandatory: self-monitoring, goal setting/review, education, feedback, contact; optional: exercise, reports, support meeting, group activities).
干预措施: Self-monitoring (Behavioral)
Physical activity coaching - Experimental group
The experimental group intervention consists of a 12-week physical activity coaching program informed by the literature (CRD42021253066). The intervention is conducted at participants' home or within the community, delivered remotely (mostly) and face-to-face, and encompasses several behaviour change components (mandatory: self-monitoring, goal setting/review, education, feedback, contact; optional: exercise, reports, support meeting, group activities).
干预措施: Goal setting and review (Behavioral)
Physical activity coaching - Experimental group
The experimental group intervention consists of a 12-week physical activity coaching program informed by the literature (CRD42021253066). The intervention is conducted at participants' home or within the community, delivered remotely (mostly) and face-to-face, and encompasses several behaviour change components (mandatory: self-monitoring, goal setting/review, education, feedback, contact; optional: exercise, reports, support meeting, group activities).
干预措施: Education (Behavioral)
Physical activity coaching - Experimental group
The experimental group intervention consists of a 12-week physical activity coaching program informed by the literature (CRD42021253066). The intervention is conducted at participants' home or within the community, delivered remotely (mostly) and face-to-face, and encompasses several behaviour change components (mandatory: self-monitoring, goal setting/review, education, feedback, contact; optional: exercise, reports, support meeting, group activities).
干预措施: Feedback (Behavioral)
Physical activity coaching - Experimental group
The experimental group intervention consists of a 12-week physical activity coaching program informed by the literature (CRD42021253066). The intervention is conducted at participants' home or within the community, delivered remotely (mostly) and face-to-face, and encompasses several behaviour change components (mandatory: self-monitoring, goal setting/review, education, feedback, contact; optional: exercise, reports, support meeting, group activities).
干预措施: Contact (Behavioral)
Physical activity coaching - Experimental group
The experimental group intervention consists of a 12-week physical activity coaching program informed by the literature (CRD42021253066). The intervention is conducted at participants' home or within the community, delivered remotely (mostly) and face-to-face, and encompasses several behaviour change components (mandatory: self-monitoring, goal setting/review, education, feedback, contact; optional: exercise, reports, support meeting, group activities).
干预措施: Exercise (Behavioral)
Physical activity coaching - Experimental group
The experimental group intervention consists of a 12-week physical activity coaching program informed by the literature (CRD42021253066). The intervention is conducted at participants' home or within the community, delivered remotely (mostly) and face-to-face, and encompasses several behaviour change components (mandatory: self-monitoring, goal setting/review, education, feedback, contact; optional: exercise, reports, support meeting, group activities).
干预措施: Report (Behavioral)
Physical activity coaching - Experimental group
The experimental group intervention consists of a 12-week physical activity coaching program informed by the literature (CRD42021253066). The intervention is conducted at participants' home or within the community, delivered remotely (mostly) and face-to-face, and encompasses several behaviour change components (mandatory: self-monitoring, goal setting/review, education, feedback, contact; optional: exercise, reports, support meeting, group activities).
干预措施: Social support (Behavioral)
Physical activity coaching - Experimental group
The experimental group intervention consists of a 12-week physical activity coaching program informed by the literature (CRD42021253066). The intervention is conducted at participants' home or within the community, delivered remotely (mostly) and face-to-face, and encompasses several behaviour change components (mandatory: self-monitoring, goal setting/review, education, feedback, contact; optional: exercise, reports, support meeting, group activities).
干预措施: Group activities (Behavioral)
Physical activity coaching - Experimental group
The experimental group intervention consists of a 12-week physical activity coaching program informed by the literature (CRD42021253066). The intervention is conducted at participants' home or within the community, delivered remotely (mostly) and face-to-face, and encompasses several behaviour change components (mandatory: self-monitoring, goal setting/review, education, feedback, contact; optional: exercise, reports, support meeting, group activities).
干预措施: World Health Organization recommendations for being physically active (Behavioral)
Usual care - Control group
The control group intervention runs parallel to the experimental group for 12 weeks, conducted at participants' home or within the community, and consists of usual management (i.e., World Health Organization's recommendations for being physically active).
干预措施: World Health Organization recommendations for being physically active (Behavioral)
结局指标
主要结局
Change in functional capacity (one-minute sit-to-stand test) from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
时间窗: Baseline, 12 weeks, 6 months and 12 months
One-minute sit-to-stand \[1minSTS\]. Patients will sit and stand from a chair, without the aid of the upper limbs, many times as they can in a 1-min bout. Afterwards, the results will be compared to age- and sex-matched reference values.
Change in Physical activity (PA) patterns (steps/day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months
时间窗: Baseline, 12 weeks, 6 months and 12 months
Patients will wear an inertial measurement unit (a three-axial accelerometer and three-axial gyroscope) for one week. A valid assessment will require a minimum of four days with at least 8 hours of wearing time, excluding weekends. The minute-by-minute output, including the number of steps and metabolic equivalents of task (METs), will be exported. Using a statistical package and an appropriate algorithm, we will extract: the total daily step count (steps/day).
Change in Physical activity (PA) patterns (time spent in light PA per day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months
时间窗: Baseline, 12 weeks, 6 months and 12 months
Patients will wear an inertial measurement unit (a three-axial accelerometer and three-axial gyroscope) for one week. A valid assessment will require a minimum of four days with at least 8 hours of wearing time, excluding weekends. The minute-by-minute output, including the number of steps and metabolic equivalents of task (METs), will be exported. Using a statistical package and an appropriate algorithm, we will extract: the total time spent in light PA per day (hours and minutes per day)
Change in Physical activity (PA) patterns (time in sedentary behaviour -lying or sitting- per day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months
时间窗: Baseline, 12 weeks, 6 months and 12 months
Patients will wear an inertial measurement unit (a three-axial accelerometer and three-axial gyroscope) for one week. A valid assessment will require a minimum of four days with at least 8 hours of wearing time, excluding weekends. The minute-by-minute output, including the number of steps and metabolic equivalents of task (METs), will be exported. Using a statistical package and an appropriate algorithm, we will extract: the total time in sedentary behaviour -lying or sitting- per day (hours and minutes per day)
Change in Physical activity (PA) patterns (time spent in moderate-to-vigorous PA per day) from baseline (pre-intervention), at 12 weeks (post-intervention), 6 months and 12 months
时间窗: Baseline, 12 weeks, 6 months and 12 months
Patients will wear an inertial measurement unit (a three-axial accelerometer and three-axial gyroscope) for one week. A valid assessment will require a minimum of four days with at least 8 hours of wearing time, excluding weekends. The minute-by-minute output, including the number of steps and metabolic equivalents of task (METs), will be exported. Using a statistical package and an appropriate algorithm, we will extract: the total time spent in moderate-to-vigorous PA per day (hours and minutes per day)
Change in functional capacity (six-minute walking test) from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months
时间窗: Baseline, 12 weeks, 6 months and 12 months
Six-minute walking test/distance \[6MWT/6MWD\]. Patients will be asked to walk as far as possible in six minutes along a flat 30m corridor. Standardised instructions and encouragement will be given during the test, following European Respiratory Society/American Thoracic Society (ERS/ATS) statement.
次要结局
- Proportion of participants with a diagnosed disease according to the International Classification of Diseases (ICD) at baseline (pre-intervention)(Baseline.)
- Change in dyspnoea symptom from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Change in isometric quadriceps strength from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Change in maximal inspiratory and expiratory pressures from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Forced expiratory volume in one second (FEV1) assessed using spirometry at baseline (pre-intervention).(Baseline.)
- Change in handgrip force from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Change in health-related quality of life from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Forced expiratory volume in one second percentage predicted (FEV1%predicted) assessed using spirometry at baseline (pre-intervention).(Baseline.)
- Sociodemographics (age) at baseline (pre-intervention).(Baseline.)
- Anthropometrics (height) at baseline (pre-intervention).(Baseline.)
- Sociodemographics (sex) at baseline (pre-intervention).(Baseline.)
- Anthropometrics (body mass index - BMI) at baseline (pre-intervention).(Baseline.)
- Change in fatigue symptom from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Change in anxiety and depression symptoms from baseline (pre-intervention) at 12 weeks (post-intervention), 6 months and 12 months(Baseline, 12 weeks, 6 months and 12 months)
- Forced vital capacity (FVC) assessed using spirometry at baseline (pre-intervention).(Baseline.)
- Ratio between Forced expiratory volume in one second and Forced vital capacity (FEV1/FVC) assessed using spirometry at baseline (pre-intervention).(Baseline.)
- Anthropometrics (weight) at baseline (pre-intervention).(Baseline.)
- Forced vital capacity percentage predicted (FVC%predicted) assessed using spirometry at baseline (pre-intervention).(Baseline.)
- Proportion of participants following any pharmacological treatment or plan, as classified by the Anatomical Therapeutic Chemical (ATC) classification system at baseline (pre-intervention).(Baseline.)
研究者
María José Yuste Sánchez
Associate Professor, Co-founder, and Co-Principal Investigator of the Physiotherapy in Women's Health Research Group - FPSM
University of Alcala