This study aims to evaluate the impact of a functional and cognitive rehabilitationstrategy compared to evidence-based informational messages, on functional capacity,cognitive abilities, quality of life, and disease progression in adults with chronicnon-communicable diseases (NCDs) and Long Covid-19.Researchers will compare a structured rehabilitation program to informational supportthrough evidence-based messages to determine if rehabilitation leads to better functionaland 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 monthslater, including a six-minute walk test, handgrip strength measurement, andquestionnaires on disability, anxiety, depression, fatigue, dyspnea, cognitive function,and quality of life.
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.
Other: Functional and cognitive rehabilitation strategy
The functional and cognitive rehabilitation strategy is a structured, supervised program,
designed to improve physical and cognitive function in patients with Long Covid-19 and
chronic diseases. Participants will attend weekly in-person sessions for 8 weeks at study
sites.
Each session includes:
- Functional Rehabilitation (60 min): Warm-up, aerobic exercise
(elliptical/treadmill), muscle strengthening, and cool-down, all supervised by
trained healthcare professionals who monitor effort levels and heart rate.
- Cognitive Rehabilitation (30 min): Memory, attention, and executive function
exercises, guided by occupational therapists or speech therapists.
Other: Evidence-Based Informational Support
The evidence-based informational support intervention provides structured, research-based
health information to patients with Long Covid-19 and chronic diseases. Participants
receive weekly digital messages for 8 weeks via email or text, covering key topics such
as Covid-19 prevention, treatment, follow-up, and prognosis.
Content is derived from high-quality scientific studies and clinical guidelines.
A total of 24 informational pieces are delivered, ensuring comprehensive coverage of
essential health recommendations.
This intervention is remote, accessible, and designed to enhance patient knowledge and
self-management, distinguishing it from traditional in-person education programs.
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.
Fundación Cardioinfantil-Instituto de cardiología
Bogotá DC, Colombia
Investigator: Karen J Moreno, PT MSc
Contact: +6016672727
kmoreno@lacardio.org
Karen J Moreno, PT MSc
+6016672727 - 73203
kmoreno@lacardio.org
Not Provided