Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05765591
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2023-03-09
Brief Title:
Balneotherapy for Patients With Post-acute Coronavirus Disease COVID Syndrome
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
Effects of Balneotherapy for Patients With Post-COVID Syndrome
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized controlled study is to evaluate the effects of balneotherapy BT and aquatic exercises in patients with post-acute COVID syndrome PACS The main question it aims to answer are
Does BT and aquatic exercises alleviate some of the most prevalent features that characterize post-acute COVID syndrome
Participants allocated to the intervention group will undergo 3 weekly sessions of BT and aquatic exercises on alternate days in groups of 8 during 4 weeks Prior the beginning of the intervention patients were asked to complete an array of validated self-reported questionnaires that covered an important part of PACS symptomatology These patients were asked to complete these same questionnaires immediately after completing the intervention and one month after They were also asked to report adverse events associated to the intervention
Patients allocated to the control group were asked to complete the same questionnaires at baseline and one and two months post-baseline They were instructed to not enroll in any kind of BT-related activities during the duration of the study
Questionnaires were analyzed and compared between groups to assess the effects of the intervention
Does BT and aquatic exercises alleviate some of the most prevalent features that characterize post-acute COVID syndrome
Participants allocated to the intervention group will undergo 3 weekly sessions of BT and aquatic exercises on alternate days in groups of 8 during 4 weeks Prior the beginning of the intervention patients were asked to complete an array of validated self-reported questionnaires that covered an important part of PACS symptomatology These patients were asked to complete these same questionnaires immediately after completing the intervention and one month after They were also asked to report adverse events associated to the intervention
Patients allocated to the control group were asked to complete the same questionnaires at baseline and one and two months post-baseline They were instructed to not enroll in any kind of BT-related activities during the duration of the study
Questionnaires were analyzed and compared between groups to assess the effects of the intervention
Detailed Description:
Participants were recruited in the multidisciplinary Post-COVID unit of the Hospital del Mar or in a primary care center in Barcelona Spain In addition Caldes de Montbuis City Council also advertised the project for patient recruitment on its public website Inclusion criteria were individuals 18 years old with a PACS diagnosis provided by a physician
Exclusion criteria included patients with preexisting disorders to the severe acute respiratory syndrome SARS coronavirus CoV 2 infection that displayed an important clinical overlap with PACS ie fibromyalgia FM chronic fatigue syndrome chronic pain and generalized anxiety disorder andor depression that required pharmacological treatment Patients with chronic debilitating conditions that required active treatment were also excluded ie cancer chronic viral infections systemic autoimmune diseases epilepsy uncontrolled endocrine disorders etc Patients with fear of water incontinence severe venous insufficiency physical disabilities that hindered performance of Balneotherapy BTaquatic exercises and those who reported a tendency for symptomatic low blood pressure were also excluded Blood tests performed within 4 months or less before the initial visit were mandatory for preselection and were reviewed patients with anaemia chronic kidney disease CKD stage 4 or less chronic liver insufficiency thyroid function abnormalities and in general any significant blood test abnormality that could be associated with PACS-related symptomatology were excluded
Included patients underwent initial visit in which clinical data was reviewed and registered Participants were randomly assigned to the intervention or control group through a lottery method Patients were asked to not vary their usual care or initiate any other kind of therapy during the duration of the study Post-Acute COVID symptoms At the time of the initial visit several clinical parameters were registered including age sex Body Mass Index BMI date of SARS-CoV-2 infection admission into the Intensive Care Unit yesno Visual Analogue Scale VAS and a large array of PACS-related symptomsyesno that were classified according to the systemorgan affected
Study design The study was designed as a prospective randomized controlled study Data was collected at 3 time points 1 initial visit baseline 2 at the end of BT or one month after baseline in control group and 3 one month after BT finalization or two months after baseline in control group Balneotherapy BT intervention The BT intervention consisted of 3 weekly sessions on alternate days in groups of 8 during 4 weeks ie 12 sessions in total The weekly planning was structured as following
1 st day Pool shower inhalation and aquatic exercise 2 nd day Pool shower inhalation 3 rd day Pool shower inhalation and aquatic exercise The exercise program was designed by qualified specialists from the Caldes de Montbui spa Exercises were performed in the thermal water pool at 32C during 2 hours At the start of the session patients were instructed to inhale thermal water vapor for 10 minutes alternating between nose and mouth Subsequently they underwent a circular shower during 10 minutes with a very fine jet that ran from the ankles to the neck to activate circulation The temperature of the water and the power of the jet was set by the patient
Next they started the exercise program which lasted 15 minutes and was structured as follows
1 Ankle joints workout knee flexions and abductors workout
2 Waist and arm rotation
3 Arm raise exercises arms were raised and lowered from legs to mid-waist Subsequently the same exercise was repeated but raising concomitantly knees and if possible clapping hands above the head
4 Hand exercises patients were instructed to open and close their hands first and then repeated the same exercise but alternating hiding or exposing their thumbs
5 Lateral neck movements
6 Cycling and rowing movements while holding onto the pools wall
7 Walking 2 laps around the pool During the last 15-20 minutes patients were allowed to relax in the whirlpool
Control group Patients from the control group were instructed to not participate in any BT-related activity during the duration of the study and to continue with usual care and activities
Primary Outcome To evaluate the effects of BT we employed an array of validated self-reported questionnaires that covered an important part of PACS symptomatology The primary outcome of the study was to evaluate differences in questionnaire scores from baseline between both groups The following scales and questionnaires were employed
1 Post-COVID-19 functional status scale PCFS
2 Modified Medical Research Council mMRC Dyspnoea Scale
3 Short Form-36 Health Survey SF-36 to evaluate generic health-related quality of life HRQL
4 Pittsburgh Sleep Quality Index PSQI
5 Hospital Anxiety and Depression Scale HADS
6 Memory failures in everyday life following severe head injury MFE-30
7 Visual Analogic Scale VAS Secondary outcomes The percentage of individuals within each group that showed any improvement in the questionnaires scores at timepoints 2 and 3 compared to baseline were also calculated and compared between groups
Statistical methods Descriptive statistics were used for demographic and clinical characteristics related to PACS Comparisons between groups for quantitative variables were performed by t-test and chi-square tests were used for qualitative variables Questionnaire scores were analysed using the intra-individual absolute change between baseline and post-BT or one month after baseline control group and between baseline and one month after completing BT or two months after baseline control group One-way ANOVA or chi-square were used for comparisons between groups The change between time points was also categorized according to whether score improvement was observed yesno
Chi-square test was used to perform the corresponding comparisons between groups
Finally univariate General Linear Model GLM or multinomial logistic regression were used for group comparisons adjusted by age and BMI Statistical analysis was done with Statistical Package for the Social Sciences SPSS Statistics version 220 P values lower than 005 were considered significant
Exclusion criteria included patients with preexisting disorders to the severe acute respiratory syndrome SARS coronavirus CoV 2 infection that displayed an important clinical overlap with PACS ie fibromyalgia FM chronic fatigue syndrome chronic pain and generalized anxiety disorder andor depression that required pharmacological treatment Patients with chronic debilitating conditions that required active treatment were also excluded ie cancer chronic viral infections systemic autoimmune diseases epilepsy uncontrolled endocrine disorders etc Patients with fear of water incontinence severe venous insufficiency physical disabilities that hindered performance of Balneotherapy BTaquatic exercises and those who reported a tendency for symptomatic low blood pressure were also excluded Blood tests performed within 4 months or less before the initial visit were mandatory for preselection and were reviewed patients with anaemia chronic kidney disease CKD stage 4 or less chronic liver insufficiency thyroid function abnormalities and in general any significant blood test abnormality that could be associated with PACS-related symptomatology were excluded
Included patients underwent initial visit in which clinical data was reviewed and registered Participants were randomly assigned to the intervention or control group through a lottery method Patients were asked to not vary their usual care or initiate any other kind of therapy during the duration of the study Post-Acute COVID symptoms At the time of the initial visit several clinical parameters were registered including age sex Body Mass Index BMI date of SARS-CoV-2 infection admission into the Intensive Care Unit yesno Visual Analogue Scale VAS and a large array of PACS-related symptomsyesno that were classified according to the systemorgan affected
Study design The study was designed as a prospective randomized controlled study Data was collected at 3 time points 1 initial visit baseline 2 at the end of BT or one month after baseline in control group and 3 one month after BT finalization or two months after baseline in control group Balneotherapy BT intervention The BT intervention consisted of 3 weekly sessions on alternate days in groups of 8 during 4 weeks ie 12 sessions in total The weekly planning was structured as following
1 st day Pool shower inhalation and aquatic exercise 2 nd day Pool shower inhalation 3 rd day Pool shower inhalation and aquatic exercise The exercise program was designed by qualified specialists from the Caldes de Montbui spa Exercises were performed in the thermal water pool at 32C during 2 hours At the start of the session patients were instructed to inhale thermal water vapor for 10 minutes alternating between nose and mouth Subsequently they underwent a circular shower during 10 minutes with a very fine jet that ran from the ankles to the neck to activate circulation The temperature of the water and the power of the jet was set by the patient
Next they started the exercise program which lasted 15 minutes and was structured as follows
1 Ankle joints workout knee flexions and abductors workout
2 Waist and arm rotation
3 Arm raise exercises arms were raised and lowered from legs to mid-waist Subsequently the same exercise was repeated but raising concomitantly knees and if possible clapping hands above the head
4 Hand exercises patients were instructed to open and close their hands first and then repeated the same exercise but alternating hiding or exposing their thumbs
5 Lateral neck movements
6 Cycling and rowing movements while holding onto the pools wall
7 Walking 2 laps around the pool During the last 15-20 minutes patients were allowed to relax in the whirlpool
Control group Patients from the control group were instructed to not participate in any BT-related activity during the duration of the study and to continue with usual care and activities
Primary Outcome To evaluate the effects of BT we employed an array of validated self-reported questionnaires that covered an important part of PACS symptomatology The primary outcome of the study was to evaluate differences in questionnaire scores from baseline between both groups The following scales and questionnaires were employed
1 Post-COVID-19 functional status scale PCFS
2 Modified Medical Research Council mMRC Dyspnoea Scale
3 Short Form-36 Health Survey SF-36 to evaluate generic health-related quality of life HRQL
4 Pittsburgh Sleep Quality Index PSQI
5 Hospital Anxiety and Depression Scale HADS
6 Memory failures in everyday life following severe head injury MFE-30
7 Visual Analogic Scale VAS Secondary outcomes The percentage of individuals within each group that showed any improvement in the questionnaires scores at timepoints 2 and 3 compared to baseline were also calculated and compared between groups
Statistical methods Descriptive statistics were used for demographic and clinical characteristics related to PACS Comparisons between groups for quantitative variables were performed by t-test and chi-square tests were used for qualitative variables Questionnaire scores were analysed using the intra-individual absolute change between baseline and post-BT or one month after baseline control group and between baseline and one month after completing BT or two months after baseline control group One-way ANOVA or chi-square were used for comparisons between groups The change between time points was also categorized according to whether score improvement was observed yesno
Chi-square test was used to perform the corresponding comparisons between groups
Finally univariate General Linear Model GLM or multinomial logistic regression were used for group comparisons adjusted by age and BMI Statistical analysis was done with Statistical Package for the Social Sciences SPSS Statistics version 220 P values lower than 005 were considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None