Physical Activity Coaching in Patients with Post-COVID-19

University of Alcala

Status: Suspended

Conditions: Post-COVID-19 Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06165978

CEID/2023/3/072

Details and patient eligibility

About

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?

Full description

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 2 patient groups

Physical activity coaching - Experimental group

Experimental group

Description:

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).

Treatment:

Behavioral: Goal setting and review

Behavioral: World Health Organization recommendations for being physically active

Behavioral: Report

Behavioral: Exercise

Behavioral: Social support

Behavioral: Group activities

Behavioral: Contact

Behavioral: Education

Behavioral: Self-monitoring

Behavioral: Feedback

Usual care - Control group

Other group

Description:

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).

Treatment:

Behavioral: World Health Organization recommendations for being physically active