Physiotherapy in Mutated COVID-19 Patients

• Sponsor: Giresun University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05874076
• Collaborator: (none)
• Enrollment: 32
• Locations: 2
• Arms: 2
• Actual Duration (Months): 6
• Patients Per Site: 16
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Pandemic	Behavioral: Physiotherapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Mutation on Short Term Physiotherapy Success in Hospitalized COVID-19 Patients: a Prospective Study
• Actual Study Start Date: Apr 30, 2021
• Actual Primary Completion Date: Oct 30, 2021
• Actual Study Completion Date: Oct 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Covid-19 group This group underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program.	Behavioral: Physiotherapy; Physiotherapy
Experimental: Mutation group This group underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program.	Behavioral: Physiotherapy; Physiotherapy

Outcome Measures

Primary Outcome Measures

1. muscle strength [an average of 9 days]

   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

1. mobility assessment [an average of 9 days]

   For the purpose of measuring mobility, the Rivermead Mobility Index (RMI) was applied.

2. Exercise capacity [an average of 9 days]

   Exercise capacity was evaluated with the 5-repetition sit to stand test (5STS).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Giresun University	Giresun	Gi̇resun	Turkey	28000
2	Giresun University	Giresun		Turkey	28000

Sponsors and Collaborators

• Giresun University

Investigators

• Principal Investigator: ULKU K SAHIN, PhD, Giresun University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ulkukezbansahin, Head of therapy and rehabilitation department, Giresun University
• ClinicalTrials.gov Identifier: NCT05874076
• Other Study ID Numbers: 2023
• First Posted: May 24, 2023
• Last Update Posted: May 24, 2023
• Last Verified: May 1, 2023

• 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: COVID-19

Study Results

No Results Posted as of May 24, 2023