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Completed

NCT Number: NCT05341648

Aerobic Exercise and Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)

To investigate the effects of aerobic exercise program on physical activity, aerobic capacity, anxiety& depression in Covid-19 survivors discharged from Intensive Care Unit. There is evidence in the literature that post-intensive case survivors who have been mechanically ventilated will likely experience short- and medium-term consequences in the form of Post Intensive Care Syndrome (PICS).

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Post Intensive Care Syndrome RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases postintensive care syndrome

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allama Iqbal International Hospital & Mega Medical Complex.

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

The notion that patients surviving intensive care and mechanical ventilation for several weeks can be discharged home without further medical attention is a dangerous illusion. Post-Intensive Care Syndrome and other severe conditions will require not only adequate screening but early rehabilitation and other interventions. So, this focused control trial will contribute particularly to determining the Effects of the Aerobic Exercise Program in Covid-19 Survivors with Post-Intensive Care Syndrome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergo mechanical ventilation in the ICU.
  • Recovered from Covid-19 & Discharged from ICU within the past 2 months.
  • Hospital Anxiety and Depression Scale (HADS)>8.
  • Scale≥ 2 on MRC Dyspnoea Scale.
  • Subjects consenting to participate in the study.

Exclusion criteria

  • Positive Covid-19 Test.
  • COPD and other respiratory diseases.
  • Pre-existing psychotic dementia-type illness.
  • Acute neurologic diseases (meningitis, ischemic hemorrhagic stroke).
  • Patients with chronic systemic disease.

Treatment and study plan

Aerobic exercise training

Other

Warm-up: 5 minutes Aerobic Training Treadmill/cycle ergometer Frequency:3 days a week Intensity:40-70% of HR max(Start from 40% than increment to as per patient tolerance) Total Duration:6 weeks. Duration of each session:15-30 mins. Cool-down: 5 minutes

Home Plan

Other
  • Positions to ease breathlessness
  • Controlled breathing/Deep breathing*10 Reps* TD,s
  • Progressive Muscle Relaxation Exercises.
  • ROM & Flexibility Exercises. 3 days a week for 6 weeks.

Primary outcomes

  1. Hospital Anxiety and Depression

    Time frame: 6 weeks

    Changes from baseline till 6 weeks, Assessed through Hospital Anxiety and Depression Scale (HADS): Questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Scoring is as followed:

    0-7 = Normal

    8-10 = Borderline abnormal (borderline case)

    11-21 = Abnormal (case)

  2. 6 min walk test: Distance (meters)

    Time frame: 6 weeks

    Changes from the baseline till the 6th week, 6 min walk test (6 MWT) was used to measure Functional capacity. It is a submaximal exercise test that can aid in assessing the functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Aerobic Exercise Program in Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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