NCT05874076

Brief Summary

The prospective study was conducted at a single location within the COVID-19 department of a city hospital. The study included COVID-19 patients who were hospitalized in the COVID-19 service and consulted for physiotherapy, were between the ages of 18 and 65, and had the capacity and inclination to participate in one daily physiotherapy session five days per week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

May 22, 2023

Last Update Submit

May 22, 2023

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (1)

  • muscle strength

    Using a scale developed by the Medical Research Council (MRC), muscle strength was measured. Using this instrument, the muscles of the lower and upper extremities are evaluated bilaterally. Each of the six main muscle groups evaluated receives a score between 0 (no contraction) and 5 (normal contraction).

    an average of 9 days

Secondary Outcomes (2)

  • mobility assessment

    an average of 9 days

  • Exercise capacity

    an average of 9 days

Study Arms (2)

Covid-19 group

ACTIVE COMPARATOR

This group underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program.

Behavioral: Physiotherapy

Mutation group

EXPERIMENTAL

This group underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program.

Behavioral: Physiotherapy

Interventions

PhysiotherapyBEHAVIORAL

Physiotherapy

Covid-19 groupMutation group

Eligibility Criteria

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

You may qualify if:

  • Patients with COVID-19 who were hospitalized in the COVID-19 service Patients were consulted for physiotherapy Patients with the capacity and willingness to participate in one daily physiotherapy session five days a week

You may not qualify if:

  • Patients who had an exercise contraindication, were uncooperative, had multi-organ failure, had an acute infection, or were PEG-fed were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Giresun University

Giresun, Gi̇resun, 28000, Turkey (Türkiye)

Location

Giresun University

Giresun, 28000, Turkey (Türkiye)

Location

Related Publications (3)

  • Lemhofer C, Gutenbrunner C, Schiller J, Loudovici-Krug D, Best N, Bokel A, Sturm C. Assessment of rehabilitation needs in patients after COVID-19: Development of the COVID-19-rehabilitation needs survey. J Rehabil Med. 2021 Apr 27;53(4):jrm00183. doi: 10.2340/16501977-2818.

    PMID: 33764478RESULT

  • Brower RG. Consequences of bed rest. Crit Care Med. 2009 Oct;37(10 Suppl):S422-8. doi: 10.1097/CCM.0b013e3181b6e30a.

    PMID: 20046130RESULT

  • Piquet V, Luczak C, Seiler F, Monaury J, Martini A, Ward AB, Gracies JM, Motavasseli D; Covid Rehabilitation Study Group. Do Patients With COVID-19 Benefit from Rehabilitation? Functional Outcomes of the First 100 Patients in a COVID-19 Rehabilitation Unit. Arch Phys Med Rehabil. 2021 Jun;102(6):1067-1074. doi: 10.1016/j.apmr.2021.01.069. Epub 2021 Feb 4.

    PMID: 33548208RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • ULKU K SAHIN, PhD

    Giresun University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of therapy and rehabilitation department

Study Record Dates

First Submitted

May 22, 2023

First Posted

May 24, 2023

Study Start

April 30, 2021

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.

Locations

TU(2)