Physical Activity Coaching in Patients with Post-COVID-19

NCT06165978 | Suspended

• 1 other identifier: CEID/2023/3/072
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Post-COVID-19 Syndrome

Keywords

physical activity; physical activity coaching; post-COVID-19

Outcome Measures

Primary Outcomes (6)

• Change in Physical activity (PA) patterns (steps/day) from baseline (pre-intervention), at 12 weeks (post-intervention), 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).

  Baseline, 12 weeks, 6 months and 12 months

• 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

  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)

  Baseline, 12 weeks, 6 months and 12 months

• 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

  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)

  Baseline, 12 weeks, 6 months and 12 months

• 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

  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)

  Baseline, 12 weeks, 6 months and 12 months

• Change in functional capacity (six-minute walking test) from baseline (pre-intervention) at 12 weeks (post-intervention), 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.

  Baseline, 12 weeks, 6 months and 12 months

• Change in functional capacity (one-minute sit-to-stand test) from baseline (pre-intervention) at 12 weeks (post-intervention), 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.

  Baseline, 12 weeks, 6 months and 12 months

Secondary Outcomes (19)

• 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 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 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

• 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

• 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

Study Arms (2)

Physical activity coaching - Experimental group

EXPERIMENTAL

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).

Behavioral: Self-monitoring; Behavioral: Goal setting and review; Behavioral: Education; Behavioral: Feedback; Behavioral: Contact; Behavioral: Exercise; Behavioral: Report; Behavioral: Social support; Behavioral: Group activities; Behavioral: World Health Organization recommendations for being physically active

Usual care - Control group

OTHER

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).

Behavioral: World Health Organization recommendations for being physically active

Interventions

Self-monitoring BEHAVIORAL

pedometer/activity band provided to each participant

Physical activity coaching - Experimental group

Goal setting and review BEHAVIORAL

Goal setting and review (weekly: +15% of the previous week's average daily steps or walking time, or +1000 steps/day or +10 minutes walking - to be specified)

Physical activity coaching - Experimental group

Education BEHAVIORAL

Educational sessions (face-to-face: providing a manual/explanatory brochure of the intervention; remote: addressing symptom pathophysiology, symptom management, among other topics)

Physical activity coaching - Experimental group

Feedback BEHAVIORAL

Daily or weekly feedback for patients (emotional/social support)

Physical activity coaching - Experimental group

Contact BEHAVIORAL

Contact with patients (face-to-face: for assessments; on remote: 1 -messages: for therapists' daily/weekly feedback or patient reports; 2 - calls: to adjust weekly goals or address doubts or issues)

Physical activity coaching - Experimental group

Exercise BEHAVIORAL

Exercise based on patient preference, explaining how to identify moderate intensity (HRmax=64-76%, Borg 3-6) or vigorous intensity (HRmax=77-95%; Borg 7-8) and monitoring safety parameters (StO2\>88%, HRmax\<96%, Borg\<9)

Physical activity coaching - Experimental group

Report BEHAVIORAL

Daily or weekly reporting for therapists (messages)

Physical activity coaching - Experimental group

Social support BEHAVIORAL

Support meetings (in-person), parallel to educational sessions

Physical activity coaching - Experimental group

Group activities BEHAVIORAL

Group activities (e.g., walking on familiar routes - parks, monumental areas, etc.)

Physical activity coaching - Experimental group

World Health Organization recommendations for being physically active BEHAVIORAL

World Health Organization's recommendations to maintain physical activity levels (i.e., 150-300 minutes/week of moderate to vigorous intensity physical activity; a weekly average of 10,000 steps/day or 100-120 minutes walking, which implies maintaining a pace of 100 steps/minute - corresponding to the average cadence across different age and gender groups).

Physical activity coaching - Experimental group; Usual care - Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead
• Colegio Profesional de Fisioterapeutas de la Comunidad de Madrid: collaborator

Study Sites (1)

University of Alcalá

Alcalá de Henares, Madrid, 28805, Spain

Location

Related Publications (19)

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MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Motor Activity

Interventions

Blood Glucose Self-Monitoring; Educational Status; Exercise

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques; Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• María José Yuste Sánchez, PT, Ph.D.

  University of Alcalá, Alcalá de Henares (Madrid), Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Co-founder, and Co-Principal Investigator of the Physiotherapy in Women's Health Research Group - FPSM

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 12, 2023
• Study Start: April 17, 2024
• Primary Completion: January 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available for one year after the final version of the database is considered complete.
• Access Criteria: Formal request to the study principal investigator.

Locations

ES (1)