Additional effects of group training and online exercise to a 12-week [...] module on [HRQoL] in [adults] with post COVID-19: [RCT], 2026, Gartemann+

[forestglip]

Additional effects of group training and online exercise to a 12-week online pacing and education module on health-related quality of life in adult patients with post COVID-19: a randomized controlled trial

Gartemann, Sophie; Luedtke, Kerstin

Abstract
This study assessed the effectiveness of a rehabilitation program on health-related quality of life (QoL) in adults with post COVID-19.

This randomized controlled trial included 78 participants assigned to an intervention group (IG, n = 38) or control group (CG, n = 40). The IG received a hybrid 12-week intervention including group training, guided conversations, and an online course with training and educational content. The CG received a passive intervention containing online education.

The primary outcome was QoL measured by the PROMIS–Preference Score (PROPr). Secondary outcomes included the PROMIS-29 Profile v2.1, cognitive function, functional status, fatigue, post-exertional malaise, dyspnea, and work productivity at six, 12, and 18 weeks.

After 12 weeks, QoL improved significantly in the IG (+ 0.06, p = 0.05) and decreased in the CG (− 0.005, p = 0.83). Ability to participate (+ 3.5, p = 0.015 vs. + 1.51, p = 0.0495) and fatigue (− 0.33, p = 0.035 vs. − 0.33, p = 0.02) improved in both groups. Cognitive function (+ 2.42, p = 0.03) improved in the IG. Sleep disturbance worsened in the CG (+ 3.22, p = 0.01).

Between-group differences were significant for physical function (p = 0.036, ε2 = 0.068), anxiety (p = 0.018, ε2 = 0.085), and sleep disturbance (p = 0.033, ε2 = 0.07), with improvements in physical function and sleep disturbance in the IG, while anxiety improved in both.

Both groups showed improvements; however, the combination of group training and home-based exercises demonstrated some advantages over online education in QoL, physical function, anxiety, and sleep disturbance.

Trial registration
https://doi.org/10.17605/OSF.IO/2UHTZ (May 16, 2023).

Web | DOI | PDF | Sport Sciences for Health | Paywall

 

[forestglip]

Secondary outcomes included the PROMIS-29 Profile v2.1, cognitive function, functional status, fatigue, post-exertional malaise, dyspnea, and work productivity at six, 12, and 18 weeks.

No mention of the result for work productivity in the abstract. I wonder what exactly that's measuring.

 

[Utsikt]

Protocol:

Sample size​

Out target sample size is 160 participants. We will attempt to recruit up to 200, assuming that not all will complete the total task. Up to 80 people can be enclosed within one run. Up to four runs can be implemented within the study period.

Abstract:

This randomized controlled trial included 78 participants assigned to an intervention group (IG, n = 38) or control group (CG, n = 40).

They didn’t even get half of their target.

No mention of the result for work productivity in the abstract. I wonder what exactly that's measuring.

Seems like it’s something called WPAI:GH or Work Productivity and Activity Impairment Questionnaire–General Health

Measured variables​

The primary outcome will be health-related quality of life measured by the PROMIS-29 Profile v2.1. Additionally, some secondary outcomes will be collected: load tolerance (DePaul Symptom Questionnaire Subscale), fatigue (Fatigue Severity Scale), work productivity (WPAI:GH), functional status (PCFS), cognitive function (PROMIS Cognitive Function Short Form 4a) and dyspnea (PROMIS Dyspnea Severity Short Form 10a).

The protocol also says this:

The results are considered significant if p < 0.05 (CI 95%) and a clinically relevant improvement value are present.

The abstract doesn’t say anything about that, and I wouldn’t be surprised if the differences were too small to matter.

 

[NelliePledge]

Someone should add up all these endless studies of various flavours of CBT for long Covid worldwide and cost out just how much has been spent trying to prove it works…..

 

[Turtle]

The authors address the health providers: "Look here we can do whole groups together and up to 12 weeks it works a little.

Had they to address the participants: : "Sorry folks is didn't last beyond 12 weeks, at least not worth mentioning in the abstract".

 

[rvallee]

Someone should add up all these endless studies of various flavours of CBT for long Covid worldwide and cost out just how much has been spent trying to prove it works…..

A sort of... systematic?... review? Uh, it's a concept worth considering. And all for results that are pretty much pseudo-random with a huge bias. But, really, if someone actually added up all the expenses, even the direct costs are truly staggering, and the indirect ones are at least two orders of magnitude higher, all for a bunch of mediocre nonsense.

 

[NelliePledge]

Y

A sort of... systematic?... review? Uh, it's a concept worth considering. And all for results that are pretty much pseudo-random with a huge bias. But, really, if someone actually added up all the expenses, even the direct costs are truly staggering, and the indirect ones are at least two orders of magnitude higher, all for a bunch of mediocre nonsense.

yes I was just thinking the staggering numbers might actually hit home with funders and their political purse holders

 

[Utsikt]

They could start with all of the trials NICE looked at and deemed too low quality to impact the recommendations in the guideline.

 

[rvallee]

It would be a very useful exercise to simply do a basic overview. No need to review them. Just count them, categorize them at a high level, add the costs and work some general concepts out of it. As long as it's a full, a "systematic", review. Of all the trials. All of them. None of that excluding 90% because they make it look bad nonsense.

Show similarities, differences, conclusions, etc. How everything that's been presented as a thing to do has already been done many times. It wouldn't need to consider anything other than meta details, information about the trials themselves.

But only people interested in pushing psychosomatic BS do this kind of work, so that's unlikely to happen. They want to present them in the best light, and it still comes out mediocre. If someone did this exercise, an executive report mainly, it would be devastating, and that's why it can't happen. The reaction to NICE said everything. I'm not sure why the similar IQWIG review had no such impact in Germany, IIRC they excluded 97% of trials because they were too awful to bother. I think they only kept three, and they were also awful.

 

[Sean]

yes I was just thinking the staggering numbers might actually hit home with funders and their political purse holders

Bean counters can be some of your most powerful allies.

 

[SNT Gatchaman]

The present study did not achieve the desired sample size. A retrospective power analysis revealed a power of 71.6%, suggesting that the study had sufficient but not optimal power to detect a true effect.

Compared with baseline, QoL improved significantly in the IG and decreased in the CG. The improvements between T0-T1 and T0-T2 exceeded the reported minimal clinical difference. However, the effect size was small and the statistical significance borderline (p = 0.05)

The ability to participate and fatigue improved significantly in both groups. Cognitive function improved significantly in the IG. Sleep disturbance worsened significantly in the CG. Between-group differences in physical function, anxiety and sleep disturbance were statistically significant. When considering clinical relevance based on PROMIS criteria (2–6 T-score points), the IG showed clinically meaningful improvements in participation (+ 3.5) and cognitive function (+ 2.42), while the CG experienced a clinically significant deterioration in sleep disturbance (-3.22) and a clinically significant improvement in fatigue (+4.9). However, fatigue improvements were only clinically relevant according to PROMIS; changes measured by the FSS did not meet thresholds for clinical significance.

The participants were asked to complete questionnaires online at baseline, after 6, 12 and 18 weeks (T0, T1, T2, and T3) after the first day of intervention.

The abstract could possibly have mentioned that —

No sustained effect was observed at follow-up (T3), which limits the conclusions regarding long-term efficacy. In terms of a dose–response relationship, it is possible that more frequent sessions (≥ 1–2 times per week), a longer intervention duration of more than twelve weeks, and/or supplementary “booster sessions” beyond the 12-week period could have enhanced and/or prolonged the effect. This would be consistent with the often protracted recovery processes associated with fatigue and cognitive impairments.

In summary, the hybrid approach presents a treatment option that could be implemented on a low-threshold and widespread basis, offering individuals with post COVID-19 and PEM access to guided exercise, knowledge, and opportunities for exchange. However, given the limited effect size and lack of sustained impact, these findings should be interpreted as preliminary. Further clinical research is necessary for a definitive assessment of efficacy and a more robust evaluation of the generalizability of the findings.