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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05341648
• Other study ID #: Rec/01089 Saad Tariq
• Status: Completed
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Post Intensive Care Syndrome
• Syndrome

Intervention

Other:
• Aerobic Exercise Training
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
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.

Locations

Country	Name	City	State
Pakistan	Allama Iqbal International Hospital & Mega Medical Complex.	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression	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)	6 weeks
Primary	6 min walk test: Distance (meters)	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.	6 weeks