Back to resultsPhysiotherapy in Mutated COVID-19 Patients
Primary Purpose
COVID-19 Pandemic
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pandemic
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients who had an exercise contraindication, were uncooperative, had multi-organ failure, had an acute infection, or were PEG-fed were excluded.
Sites / Locations
- Giresun University
- Giresun University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Covid-19 group
Mutation group
Arm Description
This group underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program.
This group underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
mobility assessment
For the purpose of measuring mobility, the Rivermead Mobility Index (RMI) was applied.
Exercise capacity
Exercise capacity was evaluated with the 5-repetition sit to stand test (5STS).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05874076
Brief Title
Physiotherapy in Mutated COVID-19 Patients
Official Title
The Effects of Mutation on Short Term Physiotherapy Success in Hospitalized COVID-19 Patients: a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Giresun University
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 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.
Detailed Description
A hospital's COVID-19 service recruited 32 participants for the study. Patients were divided into two groups: COVID-19 (n=16; age = 53.81 9.48) and mutation (n=16; age = 55.25 10.12). Both groups underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program (COVID-19 group: 9.945.85 days; mutation group: 7.632.83 days). Every patient participated in a once-daily physiotherapy program. The patients' muscle strength, mobility, daily activities, exercise capacity, and perception of fatigue were assessed. To compare groups, the mixed repeated measures ANOVA model was used.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Covid-19 group
Arm Type
Active Comparator
Arm Description
This group underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program.
Arm Title
Mutation group
Arm Type
Experimental
Arm Description
This group underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program.
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Intervention Description
Physiotherapy
Primary Outcome Measure Information:
Title
muscle strength
Description
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).
Time Frame
an average of 9 days
Secondary Outcome Measure Information:
Title
mobility assessment
Description
For the purpose of measuring mobility, the Rivermead Mobility Index (RMI) was applied.
Time Frame
an average of 9 days
Title
Exercise capacity
Description
Exercise capacity was evaluated with the 5-repetition sit to stand test (5STS).
Time Frame
an average of 9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients who had an exercise contraindication, were uncooperative, had multi-organ failure, had an acute infection, or were PEG-fed were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ULKU K SAHIN, PhD
Organizational Affiliation
Giresun University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Giresun University
City
Giresun
State/Province
Gi̇resun
ZIP/Postal Code
28000
Country
Turkey
Facility Name
Giresun University
City
Giresun
ZIP/Postal Code
28000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.
Citations:
PubMed Identifier
33764478
Citation
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.
Results Reference
result
PubMed Identifier
20046130
Citation
Brower RG. Consequences of bed rest. Crit Care Med. 2009 Oct;37(10 Suppl):S422-8. doi: 10.1097/CCM.0b013e3181b6e30a.
Results Reference
result
PubMed Identifier
33548208
Citation
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.
Results Reference
result
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Physiotherapy in Mutated COVID-19 Patients
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