Rehabilitation for People With Post COVID-19 Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Multidimensional Intervention for People With Post COVID-19 Syndrome

Conditions
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Post-COVID-19 Syndrome

Intervention / Treatment
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* Other: Multidimensional intervention
* Other: Control intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-management support group<br> | Other: Multidimensional intervention<br>* 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.<br>|
| Active Comparator: Control group<br> | Other: Control intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | At 6 weeks at the end of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | At 6 weeks at the end of the intervention | 
| 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. | Baseline | 
| 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. | At 6 weeks at the end of the intervention | 
| 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. | Baseline | 
| 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. | At 6 weeks at the end of the intervention | 
| 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. | Baseline | 
| 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. | At 6 weeks at the end of the intervention |