Evaluating the Impact of a Functional and Cognitive Strategy in Patients With Long Covid-19

Study Objective

The primary goal of this study is to evaluate the impact of a functional and cognitive rehabilitation strategy compared to evidence-based informational messages, on functional capacity, cognitive abilities, quality of life, and disease progression in adults with chronic non-communicable diseases (NCDs) and Long Covid-19.

Specific Objectives

• Determine the prevalence of Long Covid-19 among participants from previous Covid-19 institutional registries, describing the primary clinical manifestations based on symptom recurrence and severity.
• Administer a functional and cognitive rehabilitation strategy in patients with NCDs and Long Covid-19, and compare it with evidence-based informational messages

Evaluate the impact of both interventions on key clinical outcomes, including:

• Six-minute walk test performance (functional capacity)
• Montreal Cognitive Assessment (MoCA) score (cognitive function)
• EQ-5D-5L (quality of life assessment)
• Incidence of events indicating worsening of underlying conditions

Methodology

The study has been conducted in two phases. The second phase is the one being registered on this platform:

1. Phase 1: Identification and Diagnosis of Long Covid-19

• Study Design: Identification of eligible patients through institutional registries at Fundación Cardioinfantil - Instituto de Cardiología (FCI-IC) and Hospital Militar Central (HOMIL).
• Eligible Population: Adults (≥18 years) with a history of hypertension or type 2 diabetes mellitus who had a suspected acute SARS-CoV-2 infection between March 2020 and December 2021.
• Sample Size and Recruitment: Approximately 2,240 individuals were contacted, with an expected 30% prevalence of long COVID, yielding at least 672 eligible participants for the clinical trial. Screening Procedures:
• Telephone contact using a pre-established script adapted from one of the registries.
• Administration of a structured questionnaire on persistent symptoms, functional limitations, and prior health conditions. Criteria for Long Covid-19 diagnosis:
• Presence of at least two persistent, intermittent, or recurrent symptoms for at least four weeks.
• At least one symptom significantly impacting daily activities.
• Symptoms unexplained by pre-existing health conditions. Data Management: Information has been recorded in the REDCap platform, ensuring secure data collection and monitoring.

1. Phase 2: Randomized Clinical Trial

• Study Design: A parallel-group, randomized controlled trial (RCT) with active control.
• Eligible Participants: Those diagnosed with Long Covid-19 in Phase 1.

Randomization (1:1):

• Experimental Group: Functional and cognitive rehabilitation strategy.
• Control Group: Informational support with evidence-based messages.

Inclusion Criteria:

• Confirmed Covid-19 diagnosis.
• History of hypertension or diabetes before the SARS-CoV-2 infection.
• Persistent symptoms affecting daily life.
• Ability to participate in in-person rehabilitation or receive informational support.

Exclusion Criteria:

• Age >80 years.
• Advanced chronic conditions (e.g., severe heart failure, advanced kidney disease).
• Hospitalizations in the year prior to study enrollment.
• Cognitive or physical impairments preventing participation.
• Interventions

Functional and Cognitive Rehabilitation:

Duration: 8 weeks, with one session per week at the study site.

1. Functional Rehabilitation (Supervised by trained health professionals)

• Warm-up (8 min)
• Aerobic exercise (20 min on treadmill/elliptical)
• Muscle toning (8 min)
• Cool-down (8 min)

1. Cognitive Rehabilitation (Guided by occupational therapy professionals) - 30-minute sessions focusing on memory, attention, and executive functions.

Informational Support with evidence-based messages (Active Control):

Weekly delivery of evidence-based health information via email, SMS, or WhatsApp. Topics include COVID-19 prevention, treatment, and prognosis.

Three informational messages per week for 8 weeks.

Outcome Measures

1. Primary Outcomes:

• Six-minute walk test.
• MoCA cognitive assessment.
• EQ-5D-5L quality of life questionnaire.
• Incidence of clinical events related to NCD deterioration.

1. Secondary Outcomes:

• Fatigue severity (Fatigue Severity Scale).
• Anxiety and depression (Hospital Anxiety and Depression Scale).
• Disability assessment (WHO Disability Assessment Schedule 2.0).
• Dyspnea severity (MRC Dyspnea Scale).

Additionally, complementary measurements will be taken at the initial visit, post-intervention, and six months after completion to assess:

• WHO Disability Assessment Questionnaire.
• Hospital Anxiety and Depression Scale.
• Fatigue Severity Scale.
• MRC Dyspnea Scale.
• Study Timeline and Follow-up Baseline assessment (before intervention).
• Post-intervention evaluation (within 4 weeks of completion).
• Six-month follow-up assessment.
• Evaluations conducted by trained, blinded assessors to ensure objectivity.

Ethical Considerations

• Confidentiality: Participant data will be managed per ethical guidelines and stored securely.
• Voluntary Participation: Participants may withdraw without affecting their standard medical care.
• Safety Measures: Rehabilitation sessions will be supervised to mitigate risks such as fatigue or dizziness.
• Insurance Coverage: A study-specific insurance policy will provide coverage for any adverse events related to the interventions.

This study will contribute to understanding Long Covid-19 management in patients with chronic conditions, providing evidence for the development of effective rehabilitation strategies to improve patient outcomes.