NCT05373407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

May 12, 2022

Last Update Submit

December 10, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Number of repetitions performed in a 1-min Sit-to-Stand (STS) test

    8 weeks

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

    8 weeks

  • Quality of life SF-36

    8 weeks

Study Arms (2)

moderate intensity aerobic training

EXPERIMENTAL

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

low intensity aerobic training

EXPERIMENTAL

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

Interventions

participants will perform different dosage of the same intervention, one group will perform moderate intensity and the other will perform low intensity aerobic training

low intensity aerobic trainingmoderate intensity aerobic training

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • History of lower limb surgeries, fractures
  • Cardiac problems
  • Respiratory problems
  • Neurological problems
  • Systemic problems and any other contraindications for aerobic training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hail University Poly Clinic

Hail, 2442, Saudi Arabia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 13, 2022

Study Start

August 15, 2022

Primary Completion

October 30, 2022

Study Completion

December 1, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations