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

Primary Purpose

COVID-19, Aerobic Exercises, Elderly

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
aerobic exercise
Sponsored by
University of Hail
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hail University Poly Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

moderate intensity aerobic training

low intensity aerobic training

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

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.
2. Anxiety and Depression evaluated by the HAMLITON ScAnxiety and Depressionale (HADS)
Anxiety and Depression evaluated by the HAMLITON ScAnxiety and Depressionale (HADS)
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

Full Information

First Posted
May 12, 2022
Last Updated
December 10, 2022
Sponsor
University of Hail
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1. Study Identification

Unique Protocol Identification Number
NCT05373407
Brief Title
Low Versus Moderate-intensity Aerobic Training in Post-discharge COVID-19 Subjects
Official Title
A Randomized Controlled Trial Examining the Impact of Low Versus Moderate-intensity Aerobic Training in Post-discharge COVID-19 Older Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hail

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Aerobic Exercises, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
moderate intensity aerobic training
Arm Type
Experimental
Arm Description
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).
Arm Title
low intensity aerobic training
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Intervention Description
participants will perform different dosage of the same intervention, one group will perform moderate intensity and the other will perform low intensity aerobic training
Primary Outcome Measure Information:
Title
Distance walked in the 6-min walk test (6 MWT)
Description
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)
Time Frame
8 weeks
Title
Post-Covid Functional Scale (PCFS)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of repetitions performed in a 1-min Sit-to-Stand (STS) test
Description
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.
Time Frame
8 weeks
Title
2. Anxiety and Depression evaluated by the HAMLITON ScAnxiety and Depressionale (HADS)
Description
Anxiety and Depression evaluated by the HAMLITON ScAnxiety and Depressionale (HADS)
Time Frame
8 weeks
Title
Quality of life SF-36
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hail University Poly Clinic
City
Hail
ZIP/Postal Code
2442
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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