Is additional online mindfulness training beneficial in improving exercise capacity among patients with heart diseases, as compared to usual care alone?
Date of publication of the randomized controlled trial: December 2015
Design
Randomized controlled trial (RCT).
Participants
324 adult patients aged 18 and 65 years with diagnosed heart disease (ischemic, valvular, congenital heart disease, or cardiomyopathy, mean age: 43.2 years, male%: 53.7%).
Intervention
12-week structured standardized online program of mindfulness was used as intervention. The mindfulness training program included different meditations, self-reflection and yoga practices. The reviewers did not report frequency and duration of the training session.
Comparator
Comparison: Mindfulness training plus usual care versus usual care alone. Usual care referred to regular outpatient visits, lifestyle advice regarding nutrition, smoking, exercise, stress reduction, medication and other procedures if indicated.
Major Outcomes
Outcome 1: Post-intervention exercise capacity as measured by 6-minute walking test (6MWT).
Settings
This study was performed in an outpatient setting.
Comparison    Mindfulness training plus usual care versus usual care alone
Main Results
Compared to usual care alone, additional mindfulness training showed significant effect in improving 6MWT (mean difference (MD): not reported, 95% CI: -0.02 to 26.4).
Comparison: Mindfulness training plus usual care versus usual care alone in patients with heart diseases
Outcome (unit) No. of studies (Total number of participants) Mean value (SD)/No. of participants Heterogeneity test (I2) MD (95% CI) Overall quality of evidence*
Intervention Comparator
1 (m) 1 (324) 10.42 (49.0)/ 215 -4.0 (55.6)/ 109 Not applicable as there is only 1 study. Not reported (-0.02 to 26.4) Very high
Keys: SD: standard deviation; MD: mean difference; CI: confidence interval.
Comparison    Mindfulness training plus usual care versus usual care alone
Main Results
Compared to usual care alone, additional mindfulness training showed significant effect in improving 6MWT (mean difference (MD): not reported, 95% CI: -0.02 to 26.4).
Comparison: Mindfulness training plus usual care versus usual care alone in patients with heart diseases
Outcome (unit) 1 (m)
No. of studies (Total number of participants) 1 (324)
Mean value (SD)/No. of participants Intervention 10.42 (49.0)/ 215
Comparator -4.0 (55.6)/ 109
MD (95% CI) Not reported (-0.02 to 26.4)
Overall quality of evidence* Very high
Keys: SD: standard deviation; MD: mean difference; CI: confidence interval.
Conclusion
Benefits
Compared to usual care alone, additional mindfulness training improves exercise capacity among patients with heart disease. For outcome 1, the overall quality of evidence is very high. Further research is most unlikely to have an important impact on our confidence in this estimate of effect.
Harms
The authors did not report adverse events of the intervention.
Link to Original Article
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671576/
The synopsis is based on the following article:
Younge JO, Wery MF, Gotink RA, Utens EM, Michels M, Rizopoulos D, van Rossum EF, Hunink MM, Roos-Hesselink JW. Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial. PloS one. 2015 Dec 7;10(12):e0143843.


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.