COVID-19 PandemicNCT05874076
Physiotherapy in Mutated COVID-19 Patients
A study testing Physiotherapy in people with COVID-19 Pandemic, run by Giresun University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Apr 2021to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who had an exercise contraindication, were uncooperative, had multi-organ failure, had an acute infection, or were PEG-fed were excluded.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Giresun University
Giresun, Gi̇resun, 28000
Giresun University
Giresun, 28000
About this study
Official title: The Effects of Mutation on Short Term Physiotherapy Success in Hospitalized COVID-19 Patients: a Prospective Study
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.
Read the 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.
- Conditions
- COVID-19 Pandemic
- Being tested
- Physiotherapy
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyBehavioural
Physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 group | Active comparator | This group underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program. Receives: Behavioral: Physiotherapy |
| Mutation group | Experimental | This group underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program. Receives: Behavioral: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: an average of 9 days
Secondary outcomes (2)
mobility assessment
For the purpose of measuring mobility, the Rivermead Mobility Index (RMI) was applied.
Measured: an average of 9 days
Exercise capacity
Exercise capacity was evaluated with the 5-repetition sit to stand test (5STS).
Measured: an average of 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start30 Apr 2021
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulkukezbansahin, Giresun University
- Investigators
- ULKU K SAHIN, PhD, Principal investigator, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874076
- Sponsor's protocol ID
- 2023
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.
Publications
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.
PubMed 33764478Brower RG. Consequences of bed rest. Crit Care Med. 2009 Oct;37(10 Suppl):S422-8. doi: 10.1097/CCM.0b013e3181b6e30a.
PubMed 20046130Piquet 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.
PubMed 33548208
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mutation on Short Term Physiotherapy Success in Hospitalized COVID-19 Patients: a Prospective Study
- ClinicalTrials.gov ID
- NCT05874076
- Acronym / sponsor ID
- 2023
- Conditions
- COVID-19 Pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 group | Active comparator | Behavioral: PhysiotherapyThis group underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program. |
| Mutation group | Experimental | Behavioral: PhysiotherapyThis group underwent physiotherapy consisting of mobilization, normal range of motion, and a respiratory exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who had an exercise contraindication, were uncooperative, had multi-organ failure, had an acute infection, or were PEG-fed were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyPhysiotherapy | Behavioural | Covid-19 group, Mutation group |
Primary outcome
muscle strength
Time frame: 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).
2 secondary outcomes
mobility assessment
Time frame: an average of 9 days
Exercise capacity
Time frame: an average of 9 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 33764478Lemhofer 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 publication: PubMed 20046130Brower RG. Consequences of bed rest. Crit Care Med. 2009 Oct;37(10 Suppl):S422-8. doi: 10.1097/CCM.0b013e3181b6e30a.
- Results publication: PubMed 33548208Piquet 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.
- Individual participant dataSharing planned: No. The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ULKU K SAHIN, PhD principal investigator
Giresun University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with COVID-19 Pandemic, run by Giresun University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength (time frame: an average of 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05874076, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.