NCT04853966

Brief Summary

It has been found that physical activity recommendations with telerehabilitation in different disease groups improve the functional capacity, physical activities and mental health of the patients as much as the supervised exercise programs. However, there are no studies in the literature that provide online physical activity counseling in COVID-19 patients, and evaluate the effect of physical activity counseling on physical activity level, quality of life, physical performance, fatigue, kinesophobia, pain, dyspnea, mental health and behavior change levels. For this reason, this study aimed to evaluate the effect of online physical activity counseling on physical activity level, quality of life, physical performance, fatigue, kinesophobia, pain, dyspnea, mental health and behavior change level in COVID-19 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Apr 2021

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2023

Completed
Last Updated

September 21, 2023

Status Verified

April 1, 2021

Enrollment Period

1.7 years

First QC Date

April 18, 2021

Last Update Submit

September 17, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Physical activity level

    Physical activity level will be evaluated multi sensor activity monitor for 7 consecutive days.

    seven days

  • General Quality of Life

    Quality of Life will be evaluated using Short Form-36 (SF-36) Health Survey Questionnaire

    five minutes

Secondary Outcomes (7)

  • Physical performance

    ten minutes

  • Dyspnea during daily living activities

    two minutes

  • Behaviour change level

    five minutes

  • General Pain

    one minute

  • Fear of movement

    three minutes

  • +2 more secondary outcomes

Study Arms (2)

Counseling group

EXPERIMENTAL
Behavioral: Physical activity counseling

Control Group

NO INTERVENTION

Interventions

Physical activity counseling will be performed using physical activity behavior steps of the transtheoretical model.

Counseling group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who have suffered COVID-19 and have passed at 3 months after the Polymerase Chain Reaction (PCR) test turned negative
  • Volunteering to participate in the research

You may not qualify if:

  • Having another diagnosed respiratory or cardiac problem
  • Having infections during the evaluation
  • Having a skeletal-muscular disease that may affect the evaluation results
  • Having neurological and psychiatric problems
  • Individuals with restrictions that prevent being physically active during the evaluation and counseling program.
  • Pregnant individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Emek, 06490, Turkey (Türkiye)

Location

Related Publications (1)

  • Celik Z, Kafa N, Guzel NA, Kokturk N. The effects of physical activity tele-counseling intervention on physical activity, functional performance, and quality of life in post-COVID-19 conditions: a randomized controlled trial. Expert Rev Respir Med. 2024 May;18(5):321-331. doi: 10.1080/17476348.2024.2363862. Epub 2024 Jun 11.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2021

First Posted

April 22, 2021

Study Start

April 17, 2021

Primary Completion

December 17, 2022

Study Completion

June 8, 2023

Last Updated

September 21, 2023

Record last verified: 2021-04

Locations