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Rehabilitation for People With Post COVID-19 Syndrome

Primary Purpose

Post-COVID-19 Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multidimensional intervention
Control intervention
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-COVID-19 Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients of both sexes.
  • Agreed to participate.
  • Post COVID-19 patients meeting the WHO definition for this disease.

Exclusion Criteria:

  • Neurological or orthopaedic pathologies that limited voluntary movement.
  • Cognitive impairment that prevented them from understanding and answering the questionnaires.
  • Patients suffering from a reinfection with SARS-CoV-2.
  • Patients who had been hospitalized due to COVID-19 infection.
  • Patients who had pre-existing chronic pain according to the current IASP definition.

Sites / Locations

  • Faculty of Health Sciences. University of Granada.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-management support group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Perceived health-related quality of life
Health-related quality of life was assessed with the EQ-5D-5L. This is a questionnaire consisting of 5 dimensions ("mobility", "self-care", "usual activities", "pain or discomfort", and "anxiety or depression") which is widely used. Each of the dimensions has 5 possible levels. In addition, a visual analogue scale (VAS) with values ranging from 0 (worst imaginable state of health) to 100 (best imaginable state of health) is included to assess the perceived health status.
Perceived health-related quality of life
Health-related quality of life was assessed with the EQ-5D-5L . This is a questionnaire consisting of 5 dimensions ("mobility", "self-care", "usual activities", "pain or discomfort", and "anxiety or depression") which is widely used. Each of the dimensions has 5 possible levels. In addition, a visual analogue scale (VAS) with values ranging from 0 (worst imaginable state of health) to 100 (best imaginable state of health) is included to assess the perceived health status.

Secondary Outcome Measures

Change in activity levels
Activity levels will be evaluated with the International Physical Activity Questionnaire. It assess the frequency and time spent on vigorous, moderate-intensity activities and walking time for each category. Higher values indicate higher activity levels.
Change in activity levels
Activity levels will be evaluated with the International Physical Activity Questionnaire. It assess the frequency and time spent on vigorous, moderate-intensity activities and walking time for each category. Higher values indicate higher activity levels.
Changes in pain knowledge
The Neurophysiology of Pain Questionnaire was used to assess pain knowledge. It consists of 19 items with a false, true or undecided response option. For each correct answer a point is added, the maximum score being 19. The higher the score, the greater the knowledge of pain. The questions refer to the biological mechanisms of pain or how and why pain is perceived.
Changes in pain knowledge
The Neurophysiology of Pain Questionnaire was used to assess pain knowledge. It consists of 19 items with a false, true or undecided response option. For each correct answer a point is added, the maximum score being 19. The higher the score, the greater the knowledge of pain. The questions refer to the biological mechanisms of pain or how and why pain is perceived.
Changes in perceived health status
The PROMIS-29 questionnaire is divided into seven core domains (physical function, pain interference, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities) and a separate item on pain intensity. Each of the items has 5 response options except the pain intensity item which have a numerical rating scale from 0 to 10. Total scores for each domain are expressed as T-scores with a mean of 50 and a standard deviation of 10 for the U.S. reference population. Higher T-scores indicate a higher level of the underlying construct.
Changes in perceived health status
The PROMIS-29 questionnaire is divided into seven core domains (physical function, pain interference, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities) and a separate item on pain intensity. Each of the items has 5 response options except the pain intensity item which have a numerical rating scale from 0 to 10. Total scores for each domain are expressed as T-scores with a mean of 50 and a standard deviation of 10 for the U.S. reference population. Higher T-scores indicate a higher level of the underlying construct.
Changes in pain intensity and pain interference
Pain intensity and interference were measured with the Brief Pain Inventory (BPI). The pain intensity section of the BPI is composed of four items and the pain interference section is composed of seven items. For the intensity section the responses range from 0 (no pain) to 10 (worst pain) and for the interference section the responses range from 0 (no interference) to 10 (total interference). To obtain the severity and interference index, the mean of the corresponding items is calculated, obtaining values between 0 and 10, with a higher score reflecting greater pain intensity and interference. The BPI has been established as a reliable and valid tool for assessing pain severity and interference.
Changes in pain intensity and pain interference
Pain intensity and interference were measured with the Brief Pain Inventory (BPI). The pain intensity section of the BPI is composed of four items and the pain interference section is composed of seven items. For the intensity section the responses range from 0 (no pain) to 10 (worst pain) and for the interference section the responses range from 0 (no interference) to 10 (total interference). To obtain the severity and interference index, the mean of the corresponding items is calculated, obtaining values between 0 and 10, with a higher score reflecting greater pain intensity and interference. The BPI has been established as a reliable and valid tool for assessing pain severity and interference.

Full Information

First Posted
July 26, 2022
Last Updated
July 26, 2022
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT05475743
Brief Title
Rehabilitation for People With Post COVID-19 Syndrome
Official Title
Multidimensional Intervention for People With Post COVID-19 Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
September 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

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
Patients who have undergone COVID-19 infection often have long-term sequelae. One of the most prevalent sequelae is pain. The main objective of this research is to investigate the efficacy of chronic pain multidimensional intervention in patients with post-COVID-19 syndrome on health-related quality of life, activity levels, pain knowledge and pain intensity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19 Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-management support group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Multidimensional intervention
Intervention Description
The treatment protocol was 6 weeks in duration with two visits per week. One of the two visits was 1.5 hours long and was in a group format. During these group sessions patients received pain and self-management education. The second session was an individual session lasting 45 minutes. This second session was tailored specifically to each patient. Its main objective was to develop a global mobility program adapted to the physical capacity of each patient. In addition, this second session supported the implementation of self-management.
Intervention Type
Other
Intervention Name(s)
Control intervention
Intervention Description
Patients received an informational brochure in a consultation with a health professional. The brochure explained the importance of physical activity to improve the health condition of these patients. Patients had the opportunity to ask any questions to the healthcare professional.
Primary Outcome Measure Information:
Title
Perceived health-related quality of life
Description
Health-related quality of life was assessed with the EQ-5D-5L. This is a questionnaire consisting of 5 dimensions ("mobility", "self-care", "usual activities", "pain or discomfort", and "anxiety or depression") which is widely used. Each of the dimensions has 5 possible levels. In addition, a visual analogue scale (VAS) with values ranging from 0 (worst imaginable state of health) to 100 (best imaginable state of health) is included to assess the perceived health status.
Time Frame
Baseline
Title
Perceived health-related quality of life
Description
Health-related quality of life was assessed with the EQ-5D-5L . This is a questionnaire consisting of 5 dimensions ("mobility", "self-care", "usual activities", "pain or discomfort", and "anxiety or depression") which is widely used. Each of the dimensions has 5 possible levels. In addition, a visual analogue scale (VAS) with values ranging from 0 (worst imaginable state of health) to 100 (best imaginable state of health) is included to assess the perceived health status.
Time Frame
At 6 weeks at the end of the intervention
Secondary Outcome Measure Information:
Title
Change in activity levels
Description
Activity levels will be evaluated with the International Physical Activity Questionnaire. It assess the frequency and time spent on vigorous, moderate-intensity activities and walking time for each category. Higher values indicate higher activity levels.
Time Frame
Baseline
Title
Change in activity levels
Description
Activity levels will be evaluated with the International Physical Activity Questionnaire. It assess the frequency and time spent on vigorous, moderate-intensity activities and walking time for each category. Higher values indicate higher activity levels.
Time Frame
At 6 weeks at the end of the intervention
Title
Changes in pain knowledge
Description
The Neurophysiology of Pain Questionnaire was used to assess pain knowledge. It consists of 19 items with a false, true or undecided response option. For each correct answer a point is added, the maximum score being 19. The higher the score, the greater the knowledge of pain. The questions refer to the biological mechanisms of pain or how and why pain is perceived.
Time Frame
Baseline
Title
Changes in pain knowledge
Description
The Neurophysiology of Pain Questionnaire was used to assess pain knowledge. It consists of 19 items with a false, true or undecided response option. For each correct answer a point is added, the maximum score being 19. The higher the score, the greater the knowledge of pain. The questions refer to the biological mechanisms of pain or how and why pain is perceived.
Time Frame
At 6 weeks at the end of the intervention
Title
Changes in perceived health status
Description
The PROMIS-29 questionnaire is divided into seven core domains (physical function, pain interference, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities) and a separate item on pain intensity. Each of the items has 5 response options except the pain intensity item which have a numerical rating scale from 0 to 10. Total scores for each domain are expressed as T-scores with a mean of 50 and a standard deviation of 10 for the U.S. reference population. Higher T-scores indicate a higher level of the underlying construct.
Time Frame
Baseline
Title
Changes in perceived health status
Description
The PROMIS-29 questionnaire is divided into seven core domains (physical function, pain interference, anxiety, depression, fatigue, sleep disturbance, and ability to participate in social roles and activities) and a separate item on pain intensity. Each of the items has 5 response options except the pain intensity item which have a numerical rating scale from 0 to 10. Total scores for each domain are expressed as T-scores with a mean of 50 and a standard deviation of 10 for the U.S. reference population. Higher T-scores indicate a higher level of the underlying construct.
Time Frame
At 6 weeks at the end of the intervention
Title
Changes in pain intensity and pain interference
Description
Pain intensity and interference were measured with the Brief Pain Inventory (BPI). The pain intensity section of the BPI is composed of four items and the pain interference section is composed of seven items. For the intensity section the responses range from 0 (no pain) to 10 (worst pain) and for the interference section the responses range from 0 (no interference) to 10 (total interference). To obtain the severity and interference index, the mean of the corresponding items is calculated, obtaining values between 0 and 10, with a higher score reflecting greater pain intensity and interference. The BPI has been established as a reliable and valid tool for assessing pain severity and interference.
Time Frame
Baseline
Title
Changes in pain intensity and pain interference
Description
Pain intensity and interference were measured with the Brief Pain Inventory (BPI). The pain intensity section of the BPI is composed of four items and the pain interference section is composed of seven items. For the intensity section the responses range from 0 (no pain) to 10 (worst pain) and for the interference section the responses range from 0 (no interference) to 10 (total interference). To obtain the severity and interference index, the mean of the corresponding items is calculated, obtaining values between 0 and 10, with a higher score reflecting greater pain intensity and interference. The BPI has been established as a reliable and valid tool for assessing pain severity and interference.
Time Frame
At 6 weeks at the end of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients of both sexes. Agreed to participate. Post COVID-19 patients meeting the WHO definition for this disease. Exclusion Criteria: Neurological or orthopaedic pathologies that limited voluntary movement. Cognitive impairment that prevented them from understanding and answering the questionnaires. Patients suffering from a reinfection with SARS-CoV-2. Patients who had been hospitalized due to COVID-19 infection. Patients who had pre-existing chronic pain according to the current IASP definition.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Carmen Valenza, PhD
Phone
958 248035
Email
cvalenza@ugr.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences. University of Granada.
City
Granada.
State/Province
Granada
ZIP/Postal Code
18071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PT
Phone
958 248035
Email
cvalenza@ugr.es
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PT, PhD

12. IPD Sharing Statement

Learn more about this trial

Rehabilitation for People With Post COVID-19 Syndrome

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