Protocol Effects of an app-based physical training for long- and post-COVID treatment A PILOT study, 2025, Krieg+

Effects of an app-based physical training for long- and post-COVID treatment A PILOT study: protocol for a multicentre randomised controlled trial
Sarah Isabel Krieg, Lynn Matits, Lennart Mentz, Johannes Kirsten, Birgit Friedmann-Bette, Andreas Niess, Peter Deibert, Philipp Maier, Michèle Natale, Gunnar Erz, Daniel Alexander Bizjak, Jana Schellenberg

Long-and post-COVID syndrome (PCS) affect at least 65 million individuals globally, with an estimated incidence of 10% among over 651 million documented cases of SARS-CoV-2 infection. PCS impacts nearly every organ system, posing significant challenges for healthcare systems and patients. Despite this, effective guidelines for multimodal training or rehabilitation remain absent.

The app-based physical intervention for long-and post-COVID treatment (A PILOT) study is a prospective, multicentre, two-armed, randomised controlled trial to evaluate the effectiveness of an app-based multimodal training intervention in patients with PCS. 100 participants will be randomly assigned to an intervention group (IG) or a control group (CG). Over 2 months, the IG will follow a standardised app-based intervention programme incorporating breathing exercises, endurance and strength training and progressive muscle relaxation. The CG will adhere to general WHO exercise recommendations during the waiting period and gain access to the app after the study concludes.

Comprehensive assessments, including physical examinations, blood tests, psychological questionnaires, transthoracic echocardiography, electrocardiography and cardiopulmonary exercise testing, will be conducted pre-and post-intervention. The primary endpoints are the effects of app-based multimodal training on physical performance, neurocognitive function and health-related quality of life. Secondary endpoints include mental health outcomes (eg, depression, perceived stress, sleep quality and daytime sleepiness), echocardiographic and anthropometric measures and alterations in inflammatory markers and metabolites of the kynurenine pathway.
This study aims to provide critical insights into structured app-based programmes, potentially establishing a framework for improving recovery in PCS patients.

Link | PDF (BMJ Open Sport & Exercise Medicine) [Open Access]

 

a gradual, individualised approach to physical activity.

Straight from the BPS bible. They have learned nothing, and have no intention of doing so.

 

The usual problems, here's some:

Lack of a homogenous sample (worse than the Fukuda 'CFS' problem - any persistent symptoms will do)

Wait list control -

No followup and treatment is too short
The treatment is two months long, then the wait list controls get a go. So, there's no way to know if the benefits are sustained or if there are harms, relative to the controls.

There doesn't appear to be any activity monitoring, so it won't be clear if people have in fact increased their activity.

 

Yes, and not tracking what exercise the participants actually do, and after only 2 months allowing switching from control exercise to treatment exercise, so no long term followup is possible.
Apart from the fact that those with PEM are at risk of harm, the whole thing is a nonsense.

 

There is no reference for the two mentions of the WHO guidelines I have seen so far. It's not at all clear what the guidelines are for (general exercise for health; rehabilitation for Long Covid?) or what they say.

There's this:

but ref 17 is
Al-Nasser A-AN, El-Shabrawy Aboul-Enein M, Al-Aska A-K, et al. Systemic Lupus Erythematosus in Riyadh, Saudi Arabia. J R Soc Health 1988; 108:90–3.

 

As far as I can see, the PatientConcept app is not an activity monitor. It's installed on a phone. It seems to act as a compliance and instruction tool. Here's an AI description of how it works:

But the protocol says step count and overall daily activity data is recorded on the app. I'm assuming those are recoded manually by the participant.

 

I suppose they just keep on recruiting until they get enough people who can and do stick with the program.

That's really terrible. That's a fatal flaw there. I don't think they say anything about reporting drop outs.

 

I'd expect they'd rely on the phone itself to background record steps and activity. I'm assuming the app is the one described here.

PatientConcept App: Key Characteristics, Implementation, and its Potential Benefit (2019)
Lang, Michael; Mayr, Martin; Ringbauer, Stefan; Cepek, Lukas

Spoiler: Abstract

INTRODUCTION
In addition to a wide range of disease-related burdens, patients with multiple sclerosis (MS) are challenged by long-term medication and complex disease management plans, often leading to decreased adherence. Earlier studies have indicated that patient support through intensified communication can positively impact adherence. During recent years, the use of mobile health applications has gained importance in patient communication and disease management.

OBJECTIVE
Our objective was to describe a novel software application providing innovative features that engage patient–physician contact and to evaluate users’ acceptance.

METHODS
A novel software application ensuring data security was developed. Various innovative modules have been implemented, enabling bidirectional communication between treating physicians and patients, supporting therapy monitoring and management, and allowing the collection of large sets of anonymous patient data. The currently conducted FASTER study will analyze the acceptance of patients and physicians using this novel application.

RESULTS
PatientConcept is a free app available for download since 2016. Meanwhile, it has been successfully implemented. First preliminary results indicate high acceptance among users. The clinical benefit will have to be tested in larger patient populations.

CONCLUSION
This ID-associated application may provide a secure, feasible, and cost-optimized possibility to intensify and simplify the communication between patients and their treating physicians, thus promising an exceptional benefit to both.

Link | PDF (Neurology and Therapy) [Open Access]

 

So, the participants would have to have their phone on them all day?

It's a little bit frightening. All the data gets stored in Germany somewhere.

 

Can we see in that register what the protocol at the time of the ethics approval was? It would be easy to adjust that % of the program completed number in order to produce the desired result.

Ah, Table 1 shows that step counts and daily activity are secondary outcomes. They are said to be 'tracked by the app'. If the tracking is accurate and automatically recorded, then that is good, and it will be interesting to see results. But, two months is too short to know if the level of activity can be sustained.