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]

 

I can barely imagine how many ways this can go wrong. The only good news is if they do a subgroup breakdown on post intervention cardiovascular exercise testing. My guess is this whole approach will be invalidated.

I suspect they will have no issues with finding participants initially. I do wonder how very many will drop out though.

 

They will be comparing exercise against exercise.

 

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]

 

They have already started the study, so the protocol is very delayed..

 

This seems like a step beackwards from smartwatches..

 

Germany has the GDPR through EU. The data isn’t going anywhere anytime soon.

 

Date of ethics committee application:
2023-05-19
Ethics committee number:
82/23
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-06-07

​

I’m trying to figure out how to get a copy of the application, if it’s even possible.

 

There are actually 4 different ethical clearnaces. Only the first one (above) was given before the trial started. The other three were voted on in June, August and October 2024.

 

They don't even know why they're doing this. They talk about this being promising, which actually means they want it to work, and frame it on deconditioning, which is obviously not a problem and has been debunked plenty, while completely misunderstanding what PEM is. As is tradition. Because it's undeniably clear that health care professionals are trained not to listen, but to selectively interpret. So they never actually listen to what people tell them unless it fits with their expectations.

Again the problem is with oversight. There just isn't any. This study is worthless and should not have been approved, yet alone funded. Money is handed several hundred times to do the same thing and expect the same results, in that they expect the results to be indefinitely promising, so they can keep doing small pilot studies while trying to the find the right way to cheat to get a small blip of a signal that they will pretend equals 100% efficacy.

This is fraudulent horseshit, basically.

 

A phone can't do that reliably, it likely has to be logged manually, or they don't mention but it relies on a wrist device for this. And anyway they don't want those records, they give away the lie.