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

[SNT Gatchaman]

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]

 

[SNT Gatchaman]

For PCS patients, exercise represents a promising strategy to counteract deconditioning, improve physical performance and alleviate fatigue. Pulmonary rehabilitation programmes focusing on respiratory and muscular recovery have shown significant benefits, improving exercise capacity and reducing dyspnoea in PCS patients. However, the complex pathophysiology of PCS, characterised by symptoms like exercise intolerance and post-exertional malaise, necessitates a gradual, individualised approach to physical activity.

 

[Sean]

a gradual, individualised approach to physical activity.

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

 

[alex3619]

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.

 

[Hutan]

The usual problems, here's some:

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

Eligible participants include female and male patients aged 18 to 65 with persistent symptoms following SARS-CoV-2 infection.

Wait list control -

The control group (CG) will follow general exercise recommendations based on WHO guidelines during the waiting period and will gain access to the app-based programme after study completion

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.

 

[Utsikt]

The CG will adhere to general WHO exercise recommendations during the waiting period and gain access to the app after the study concludes.

They will be comparing exercise against exercise.

 

[Trish]

They will be comparing exercise against exercise.

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.

 

[Hutan]

In contrast, CG receives general physical activity recommendations per WHO guidelines during the baseline examination.

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:

The WHO highlights the importance of personalised exercise programmes tailored to patients’ symptoms to restore muscle strength and endurance.17

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.

 

[Hutan]

Exercise monitoring
In the IG, daily physical activity will be monitored using the PatientConcept app (NeuroSys GmbH, Ulm, Germany) throughout the study period. The app complies with the General Data Protection Regulation requirements and the European Data Protection Regulation 2016/679. According to the Medical Device Directive 92/43/EWG, it is also certified as a Class I medical device. Participants randomised to the IG will receive access to the app and detailed usage instructions during the baseline examination. The app will record data on the step count and overall daily activity, while adherence to the prescribed exercise sessions will also be tracked. These metrics will provide valuable insights into individual progress and trends in development throughout the study.

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:

The PatientConcept app is a smartphone app that provides exercise training programs for patients with Parkinson's disease. The app offers short videos that focus on balance, flexibility, strength, and more.
How does it work?

• A therapist chooses a program for each patient based on their symptoms and physical condition
• Patients include the exercises in their daily routine
• Patients provide feedback about their condition, mood, and training status
• Therapists supervise patients' progress and can be contacted directly
• Therapists call patients every 2–3 weeks for assessments and adjustments

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.

 

[Hutan]

Statistical considerations
... Inclusion in the final analysis will require participants to demonstrate adherence to at least 70% of the prescribed intervention, encompassing both training volume and intensity, and completion of at least 70% of the overall training programme.

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.

 

[SNT Gatchaman]

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]

 

[Utsikt]

The study has received approval from the local ethics committees of Ulm University (Number 82/23) and is registered at the German Clinical Trials Register (DRKS00034476). The first study participant was included at the University Hospital Ulm on 6 March 2024. Results will be published after the completion of the study, which is expected after July 2025

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

 

[Hutan]

I'd expect they'd rely on the phone itself to background record steps and activity.

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

and allowing the collection of large sets of anonymous patient data

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

 

[Utsikt]

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]

In addition, the app can provide patients’ mobility data (given the patients’ consent), using step tracking recorded via smartphone (data collected from health containers) to monitor patient mobility over a longer range of time. Diaries completed by the patient to capture migraine attacks, spasticity, blood sugar level, pregnancy, quality of life, depression, and fatigue further extend the possibilities of patient monitoring.

This seems like a step beackwards from smartwatches..

 

[Hutan]

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

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.

 

[Utsikt]

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

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

 

[Utsikt]

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.

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.

 

[Utsikt]

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.

 

[rvallee]

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.

 

[rvallee]

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.

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.