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

Fundación Cardioinfantil Instituto de Cardiología

Status: Not yet enrolling

Conditions: Hypertension; Long COVID; Diabetes Mellitus; Noncommunicable Disease; Long COVID-19 Syndrome; COVID 19

Treatments: Other: Evidence-Based Informational Support; Other: Functional and cognitive rehabilitation strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT06871293

2024PROEPI0164

ATENEA-366-2022 (Other Grant/Funding Number)

Details and patient eligibility

About

This study aims 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.

Researchers will compare a structured rehabilitation program to informational support through evidence-based messages to determine if rehabilitation leads to better functional and cognitive outcomes in patients with Long Covid-19.

Participants will be randomly assigned to one of two groups:

1. Functional and cognitive rehabilitation: Attending weekly in-person sessions for 8 weeks, including supervised physical and cognitive exercises.
2. Informational support: Receiving weekly evidence-based educational messages for 8 weeks.

Participants will undergo assessments at baseline, post-intervention, and six months later, including a six-minute walk test, handgrip strength measurement, and questionnaires on disability, anxiety, depression, fatigue, dyspnea, cognitive function, and quality of life.

Full description

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.

2. 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)

2. 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.

2. 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.

Enrollment: 374 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Covid-19 confirmed.
• History of arterial hypertension or diabetes mellitus before entering the institutional registries of the FCI-IC or HOMIL, institutional registries of the FCI-IC or HOMIL or before having the diagnosis of SARSCoV-2 infection.
• Persistence of two or more concurrent symptoms, related to Covid-19 prologue, for at least 4 weeks (persistent, intermittent, or intermittent).
• At least one of these symptoms must have an impact on activities of daily living. They can be physical (fatigue, dyspnea, myalgias, arthralgias) or neuropsychiatric (cognitive, sleep and emotional alterations).
• Symptoms unexplained by underlying disease or other condition concomitant with SARS-CoV-2 infection. SARS-CoV-2 infection (determined by prior medical history review and participant interview).

participant interview).

• Ability to read and attend functional and cognitive rehabilitation sessions or to receive the with evidence-based informational messages.

Exclusion criteria

• Age >80 years.
• Severely advanced baseline comorbidities prior to SARS-CoV-2 infection.
• Presence of chronic respiratory disease (partial or permanent supplemental oxygen use), cardiac failure (LVEF<40%) or advanced renal disease (GFR<30%).

heart failure (LVEF<40%) or advanced renal disease (GFR<30).

• Two hospitalizations in the year prior to admission to the institutional registries of the FCI-IC and the HOMIL for the patient's underlying disease.
• Dependence on a caregiver.
• Orthopedic or cardiopulmonary problems that contraindicate the performance of aerobic exercise.
• Neuropsychiatric or cognitive limitations that limit understanding or following commands and performing attention exercises.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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374 participants in 2 patient groups

Functional and Cognitive Rehabilitation

Active Comparator group

Description:

Participants assigned to the functional and cognitive rehabilitation strategy will attend one weekly session for 8 weeks at study sites. Each session includes one hour of functional rehabilitation (warm-up, aerobic exercise, muscle strengthening, and cool-down) supervised by healthcare professionals who monitor effort levels and heart rate. Additionally, participants will receive 30 minutes of cognitive rehabilitation, focusing on memory, attention, and executive functions, guided by occupational therapists or speech therapists. This intervention aims to enhance physical and cognitive function in patients with chronic diseases and Long Covid-19.

Treatment:

Other: Evidence-Based Informational Support

Evidence-Based Informational Support

Active Comparator group

Description:

Participants assigned to the evidence-based informational support arm will receive weekly educational messages for 8 weeks via email or text messages. These messages are derived from a thorough review of high-quality scientific studies and cover key topics related to Covid-19 prevention, treatment, follow-up, and prognosis. A total of 24 informational pieces will be delivered, ensuring patients receive clear, research-based guidance to support their health management. This intervention aims to improve patient awareness and self-care strategies for Long Covid-19 and chronic conditions.

Treatment:

Other: Functional and cognitive rehabilitation strategy