An interventional study of Walking APP Group and Functional APP group in Coronavirus Infection and Respiratory Disease, sponsored by University of Valencia. Completed at 1 site in Spain. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-10-17.
Sponsored by University of Valencia · Not applicable, Interventional, and Treatment
The syndrome characterized by the persistence of symptoms typical of COVID-19, beyond 4 weeks after discharge, is called long COVID. Long COVID affects a high percentage of patients who have suffered from COVID-19, regardless of its severity. The various symptoms present in that patients affect the functionality and physical, mental and psychological capacities of patients. Therefore, it is necessary to implement therapeutic programs, based on exercises and techniques of physiotherapy, to help affected people to resume their work, family, social and sports activities; prior to illness. Given the context in which these programs must be developed, telecare is positioned as the most recommended care method to carry out the rehabilitation of these patients. The general objective of this study is to evaluate the effectiveness of a cardiorespiratory tele-rehabilitation program in persistent COVID-19 patients. Study participants (n=60) will be randomly assigned to one of two intervention groups. Group 1 will combine breathing exercises with aerobic exercise: walk; and group 2 will perform functional exercises in addition to respiratory physiotherapy with. All participants will be evaluated at the beginning of the intervention, at the end of it.
7,641 studies on the registry are indexed under COVID-19; 487 are open to participants now.
This study's enrollment of 70 is below the median of 100 across 4,100 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Walking APP Group
Procedure: Functional APP group
The participants of this group will be explained their treatment plan by a physiotherapist who will contact them through a video call. This treatment will consist of breathing exercises (abdominodiaphragmatic and pursed lips breathing) and 3 days of aerobic exercise: walking. Participants will consult their treatment plan through an application that will be installed on their mobile phone. They will start with 25 minutes of walking and will increase progressively until they reach 45 minutes. A biweekly follow-up will be carried out through a phone call by the research team to find out their health status and evolution with the assigned treatment. Participants must perform the proposed exercises, 5 days a week, once a day In addition to the respiratory physiotherapy guideline, they will be given the health education manual.
The participants of this group will be explained their treatment regimen by a physiotherapist who will contact them through a video call. This treatment planwill consist of breathing exercises (abdominodiaphragmatic and pursed lips breathing) and 3 days of functional exercise which involve the activation and performance of large muscle groups. Participants will consult their treatment plan through an application that will be installed on their mobile phone. A biweekly follow-up will be carried out through a phone call by the research team to find out their health status and evolution with the assigned treatment.
Quality of life (EQ-5D-5L)
The EQ-5D-3L is a short and simple scale consisting of 2 parts. In the first of the pages, a total of 5 questions allow evaluating five different dimensions: mobility, self-care, habitual activities, pain / discomfort and anxiety / depression. In the second part, through a Visual Analogue Pain Scale (VAS), the patient can quantify, from 0 to 100, her perceived health status at the time of evaluation
Time frame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Quality of life (EQ-5D-5L) Change from Baseline PostCovid-19 Functional Satatus Scale at five months (PCFSS)
The PCFS items assess the functional limitations that post-COVID-19 patients The EQ-5D-3L is a short and simple scale consisting of 2 parts. In the first of the pages, a total of 5 questions allow evaluating five different dimensions: mobility, self-care, habitual activities, pain / discomfort and anxiety / depression. In the second part, through a Visual Analogue Pain Scale (VAS), the patient can quantify, from 0 to 100, her perceived health status at the time of evaluation
Time frame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Fatigue Assessment Scale (FAS)
The scale consists of 10 items through which the fatigue experienced by the subject can be assessed at two levels: physical and mental. Participants in this study must answer how often the situations described in each item on the scale occur. To do this, they must quantify each statement with a number from 1 to 5, where 1 is never; and 5, always.
Time frame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
London Chest Activity of Daily Living Scale (LCADL)
The LCADL was designed with the purpose of assessing the level of dyspnea, reported by patients with pulmonary pathology, during the performance of ADL. The LCADL scale therefore makes it possible to assess and adequately monitor the functional deterioration that patients experience as a consequence of their dyspnea. Throughout its development, this scale explores 4 different dimensions: self-care, home activities, physical activity and leisure activities.
Time frame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Hospital Anxiety and Depression Scale (HADS)
The HADS scale is a widely used instrument to assess the degree of emotional distress suffered by people with pathology. The scale consists of 14 items that consider cognitive, affective and behavioral aspects; but not somatic. The original version of the HADS has been validated and translated into different languages, including Spanish
Time frame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Perceived Stress Scale (PSS)
The PSS allows evaluating the level of stress perceived by patients during the last month It is made up of 14 items that explore the thoughts and feelings of the respondent that can be related to high levels of stress. The higher the score, the higher the level of perceived stress.
Time frame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Beck Depression Inventory (BDI-2)
The BDI-2, through its 21 items, aims to help the health professional to identify and measure the severity of symptoms, typical of a depressive process, in the adult population
Time frame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Exercise tolerance. Thirty Seconds Sit-To-Stand
Exercise tolerance will be assessed using the Thirty Seconds Sit-To-Stand test (30stst), as it has proven to be a useful test to evaluate the strength and endurance of the lower limbs and determine the patient's tolerance to physical activity
Time frame: It will be evaluated in two moments: Pre intervention: before starting the exercise program Post intervention: after 8 weeks of physiotherapy intervention
Plan to share: No — IPD are not to be shared with other researchers
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Valencia