Evidence map›Paper›PMID 41066658›Full record

Trial reportJournal of medical Internet research2025

Effectiveness of the Self-Directed mHealth Exercise Intervention re.flex in Patients With Knee Osteoarthritis: Randomized Controlled Trial.

Valerie Dieter, Peter Martus, David Seißler, Lina Maria Serna-Higuita, Pia Janssen, Inga Krauss

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of medical Internet research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Valerie DieterDepartment of Sports Medicine, Medical Clinic, University Hospital Tübingen, Hoppe-Seyler-Str. 6, Tübingen, 72076, Germany, 49 70712986477.ORCID http://orcid.org/0000-0003-1874-115X
Peter MartusDepartment for Clinical Epidemiology and Applied Biostatistics, Medical Clinic, University Hospital Tübingen, Tübingen, Germany.ORCID http://orcid.org/0000-0002-5386-5732
David Seißlerfbeta GmbH, Berlin, Germany.ORCID http://orcid.org/0009-0009-7038-0823
Lina Maria Serna-HiguitaDepartment for Clinical Epidemiology and Applied Biostatistics, Medical Clinic, University Hospital Tübingen, Tübingen, Germany.ORCID http://orcid.org/0000-0001-5182-8295
Pia JanssenDepartment of Sports Medicine, Medical Clinic, University Hospital Tübingen, Hoppe-Seyler-Str. 6, Tübingen, 72076, Germany, 49 70712986477.ORCID http://orcid.org/0009-0009-9965-7566
Inga KraussDepartment of Sports Medicine, Medical Clinic, University Hospital Tübingen, Hoppe-Seyler-Str. 6, Tübingen, 72076, Germany, 49 70712986477.ORCID http://orcid.org/0000-0001-6818-6276

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: About 1 in 2 patients with knee osteoarthritis (OA) receives a referral or recommendation for exercise. Digital health applications could counteract this undersupply. Objective: We aimed to investigate the effectiveness of a 12-week self-directed mobile health exercise intervention (re.flex) when used in addition to usual care compared to a control group receiving usual care only on pain reduction and improvement in physical function in patients with knee OA. Methods: This monocentric, 2-arm, randomized controlled parallel-group trial included patients from Germany with moderate to severe knee OA. Participants were mainly recruited via newspapers. Randomization was 1:1 into an intervention group (re.flex+usual care) and a control group (usual care) using computer-generated blocks. Participants were unmasked to group assignment. The re.flex group conducted a 12-week self-directed app-based and sensor-assisted exercise program with 3 sessions per week in addition to usual care. Primary outcomes were OA-specific knee pain and physical function (using the subscales pain and activities in daily living of the Knee Osteoarthritis Outcome Score, 0-100) at 3 months. Secondary outcomes included adherence and safety. Multiple imputation was used to account for missing data. Intervention effects were calculated using a baseline-adjusted analyses of covariance (ANCOVA). Bonferroni correction with an alpha level of .025 was applied. Results: Between January 25, 2023, and August 11, 2023, a total of 195 participants were enrolled. Of them, 98 participants were allocated to re.flex, and 97 participants to usual care. The primary analysis included 194 participants. The mean age was 61.9 (SD 7.7) years, and the majority were female (132/194, 68%). Pain reduction was significantly larger in re.flex than in usual care, with an adjusted mean difference between study groups of 4.8 (95% CI 0.7-8.9; P=.02; Cohen d=0.35) points. Improvement in physical function was not statistically significant (beta coefficient [β]=3.9 points, 95% CI 0.0-7.9, P=.049). A total of 12 adverse events were linked to re.flex, none of which were serious. Participants adhered to 77% (2705/3528) of all scheduled exercise sessions. Conclusions: The self-directed sensor-based mobile health exercise intervention re.flex demonstrates superiority over usual care for pain reduction and justifies this kind of intervention as an alternative exercise delivery mode for patients with knee OA.

Indexed as

Exercise TherapyOsteoarthritis, KneeTelemedicineAgedFemaleGermanyHumansMaleMiddle AgedMobile Applicationsdigital healthexercise interventionknee osteoarthritisknee painmHealthphysical function

Identifiers

PMID41066658
PMCPMC12510439

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.