Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
Study NCT ID:
NCT06871293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of a Functional and Cognitive Strategy in Patients with Long Covid-19
Sponsor:
Fundación Cardioinfantil Instituto de Cardiología
Organization:
Study Overview
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.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ATENEA-366-2022 | OTHER_GRANT | Agencia Distrital para la Educación Superior, la Ciencia y la Tecnología-ATENEA | View |