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

NCT05341648 | Completed DMC

• 1 other identifier: Rec/01089 Saad Tariq
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COVID-19; Post Intensive Care Syndrome

Keywords

Aerobic exercise; COVID-19 Survivors; Post Intensive Care Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

Aerobic Training for 3 days/week with 40-70% Intensity for 6 Weeks

Other: Aerobic Exercise Training

Control group

PLACEBO COMPARATOR

Home plan: Positioning, Breathing Exercises, Muscle Relaxation, and Flexibility exercises for 6 weeks

Other: Home Plan

Interventions

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

Experimental Group

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.

Control group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Allama Iqbal International Hospital & Mega Medical Complex.

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

COVID-19; postintensive care syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mehwish Waseem, MSPT(CPPT)

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 22, 2022
• Study Start: April 30, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)