Clinical trial NCT06871293: Evaluating the Impact of a Functional and Cognitive Strategy in Patients with Long Covid-19
Official title: Impact of Functional and Cognitive Rehabilitation, in Adults with Chronic Noncommunicable Diseases and Long Covid-19 , on Their Functional and Cognitive Capacity, Quality of Life, and the Evolution of Their Baseline Condition, in Bogotá D.C.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Long COVID-19 Syndrome
COVID 19
Noncommunicable Disease
Hypertension
Diabetes Mellitus
Long COVID
Keywords: Covid 19
Sars CoV 2
Post-acute Covid-19 syndrome
Long Covid
Hypertension
Diabetes Mellitus
Noncommunicable disease
Rehabilitation
Lead sponsor: Fundación Cardioinfantil Instituto de Cardiología
Sponsor class: OTHER
Collaborators: name: Hospital Militar Central, Colombia
First posted: 2025-03-11
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-group, randomized controlled trial (RCT) with active control.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite Change in Functional Capacity, Cognitive Function, Health-Related Quality of Life, and Strength
timeFrame: Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.
Secondary outcomes:
measure: Change in Functional Capacity
timeFrame: Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.
measure: Change in Cognitive Function
timeFrame: Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.
measure: Change in Health-Related Quality of Life
timeFrame: Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.
measure: Change in Health-Related Quality of Life, Visual Analogue Scale
timeFrame: Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.
measure: Change in Handgrip Strength, Hydraulic Dynamometer
timeFrame: Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.
measure: Incidence of Chronic Disease Decompensation Events
timeFrame: Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.
measure: Additional Functional and Clinical Assessments
timeFrame: Baseline (Day 1), 4 weeks post-intervention, and 6-month follow-up.
Other outcomes:
Locations:
city: Bogotá DC
country: Colombia
facility: Fundación Cardioinfantil-Instituto de cardiología
Study officials:
References: