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

Sponsor
University of Hail (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05373407
Collaborator
(none)
77
2
6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: aerobic exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
77 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial Examining the Impact of Low Versus Moderate-intensity Aerobic Training in Post-discharge COVID-19 Older Subjects
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Distance walked in the 6-min walk test (6 MWT) [8 weeks]

    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)

  2. Post-Covid Functional Scale (PCFS) [8 weeks]

    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

  1. Number of repetitions performed in a 1-min Sit-to-Stand (STS) test [8 weeks]

    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. 2. Anxiety and Depression evaluated by the HAMLITON ScAnxiety and Depressionale (HADS) [8 weeks]

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

  3. Quality of life SF-36 [8 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Hail

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Abdelmoniem Ibrahim, Associate professor, University of Hail
ClinicalTrials.gov Identifier:
NCT05373407
Other Study ID Numbers:
  • 00000
First Posted:
May 13, 2022
Last Update Posted:
May 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 13, 2022