Low Versus Moderate-intensity Aerobic Training in Post-discharge COVID-19 Subjects

A Randomized Controlled Trial Examining the Impact of Low Versus Moderate-intensity Aerobic Training in Post-discharge COVID-19 Older Subjects

The main purpose of this study is to compare the impact of low versus moderate-intensity aerobic training in post-COVID 19 older subjects.

On exercise adherence and changes in physical fitness, psychological status, and quality of life after a 10-week intervention.

Study Overview

• Status: Completed
• Conditions: COVID-19; Elderly; Aerobic Exercises
• Intervention / Treatment: Other: aerobic exercise

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Hail, Saudi Arabia, 2442
    • Hail University Poly Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age range of 60 - 80 years with
• diagnosis of post-COVID-19

Exclusion Criteria:

• • History of lower limb surgeries, fractures

  • Cardiac problems
  • Respiratory problems
  • Neurological problems
  • Systemic problems and any other contraindications for aerobic training

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: moderate intensity aerobic training; The exercises were conducted at a heart rate of 50-70% of maximum heart rate for 30 minutes. Exercises were included strengthening muscles groups (shoulder flexors, extensors, abductor's muscles, hip flexors, extensor muscles, knee flexors, extensor muscles, abdominal muscles, and back muscles).	Other: aerobic exercise; participants will perform different dosage of the same intervention, one group will perform moderate intensity and the other will perform low intensity aerobic training
Experimental: low intensity aerobic training; Exercises were performed at 40-50% of the maximum heart rate Starting by 15 minutes of Warm-up time included static stretching of upper and lower body muscles. After that, participants performed 30 minutes of low-intensity aerobic training exercises, which included 20 minutes on the treadmill, followed by 10 minutes of cooling down. A set of 5-10 exercises was performed by each muscle group, three sets per exercise were performed, and 10-15 repetitions per series were performed 4 days per week	Other: aerobic exercise; participants will perform different dosage of the same intervention, one group will perform moderate intensity and the other will perform low intensity aerobic training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance walked in the 6-min walk test (6 MWT)	The 6-min walk test (6 MWT) measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). (ATS Statement: Guidelines for the Six-Minute Walk Test, Am J Respir Crit Care Med, 2002)	8 weeks
Post-Covid Functional Scale (PCFS)	This scale measures the functional state and Independence of patients after COVID-19 infection. The scale includes two items scored from 0-4 and 0-5. A high value indicates more restrictions in function and independence during daily life.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of repetitions performed in a 1-min Sit-to-Stand (STS) test	All 1-min STS tests are performed according to a standardized protocol by trained study staff. A standard chair is used with a flat seat and no armrests, stabilized against a wall. Patients are asked to sit with their legs hip-width apart and flexed to 90°, with their hands stationary on the hips.	8 weeks
2. Anxiety and Depression evaluated by the HAMLITON ScAnxiety and Depressionale (HADS)	Anxiety and Depression evaluated by the HAMLITON ScAnxiety and Depressionale (HADS)	8 weeks
Quality of life SF-36	The SF-36 SF was used to evaluate self-reported domains of health status. This questionnaire consists of 36 items compiled into 8 scalesThe SF-36 questionnaire was used to evaluate self-reported domains of health status (Ware and Sherbourne, 1992). This questionnaire consists of 36 items compiled into 8 scales: physical functioning (PF), role functioning/physical (RP), bodily pain (BP), general health (GH), vitality (VT), social funct	8 weeks

Collaborators and Investigators

• Sponsor: University of Hail

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 10, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 00000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No