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Meta-Analysis
. 2021 May 7;5(5):CD010876.
doi: 10.1002/14651858.CD010876.pub3.

Exercise-based cardiac rehabilitation for adults after heart valve surgery

Affiliations
Meta-Analysis

Exercise-based cardiac rehabilitation for adults after heart valve surgery

Lizette N Abraham et al. Cochrane Database Syst Rev. .

Abstract

Background: The impact of exercise-based cardiac rehabilitation (CR) following heart valve surgery is uncertain. We conducted an update of this systematic review and a meta-analysis to assess randomised controlled trial evidence for the use of exercise-based CR following heart valve surgery.

Objectives: To assess the benefits and harms of exercise-based CR compared with no exercise training in adults following heart valve surgery or repair, including both percutaneous and surgical procedures. We considered CR programmes consisting of exercise training with or without another intervention (such as an intervention with a psycho-educational component).

Search methods: We searched the Cochrane Central Register of Clinical Trials (CENTRAL), in the Cochrane Library; MEDLINE (Ovid); Embase (Ovid); the Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO); PsycINFO (Ovid); Latin American Caribbean Health Sciences Literature (LILACS; Bireme); and Conference Proceedings Citation Index-Science (CPCI-S) on the Web of Science (Clarivate Analytics) on 10 January 2020. We searched for ongoing trials from ClinicalTrials.gov, Clinical-trials.com, and the World Health Organization International Clinical Trials Registry Platform on 15 May 2020.

Selection criteria: We included randomised controlled trials that compared exercise-based CR interventions with no exercise training. Trial participants comprised adults aged 18 years or older who had undergone heart valve surgery for heart valve disease (from any cause) and had received heart valve replacement or heart valve repair. Both percutaneous and surgical procedures were included.

Data collection and analysis: Two review authors independently extracted data. We assessed the risk of systematic errors ('bias') by evaluating risk domains using the 'Risk of bias' (RoB2) tool. We assessed clinical and statistical heterogeneity. We performed meta-analyses using both fixed-effect and random-effects models. We used the GRADE approach to assess the quality of evidence for primary outcomes (all-cause mortality, all-cause hospitalisation, and health-related quality of life).

Main results: We included six trials with a total of 364 participants who have had open or percutaneous heart valve surgery. For this updated review, we identified four additional trials (216 participants). One trial had an overall low risk of bias, and we classified the remaining five trials as having some concerns. Follow-up ranged across included trials from 3 to 24 months. Based on data at longest follow-up, a total of nine participants died: 4 CR versus 5 control (relative risk (RR) 0.83, 95% confidence interval (CI) 0.26 to 2.68; 2 trials, 131 participants; GRADE quality of evidence very low). No trials reported on cardiovascular mortality. One trial reported one cardiac-related hospitalisation in the CR group and none in the control group (RR 2.72, 95% CI 0.11 to 65.56; 1 trial, 122 participants; GRADE quality of evidence very low). We are uncertain about health-related quality of life at completion of the intervention in CR compared to control (Short Form (SF)-12/36 mental component: mean difference (MD) 1.28, 95% CI -1.60 to 4.16; 2 trials, 150 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD 2.99, 95% CI -5.24 to 11.21; 2 trials, 150 participants; GRADE quality of evidence very low), or at longest follow-up (SF-12/36 mental component: MD -1.45, 95% CI -4.70 to 1.80; 2 trials, 139 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD -0.87, 95% CI -3.57 to 1.83; 2 trials, 139 participants; GRADE quality of evidence very low). AUTHORS' CONCLUSIONS: Due to lack of evidence and the very low quality of available evidence, this updated review is uncertain about the impact of exercise-CR in this population in terms of mortality, hospitalisation, and health-related quality of life. High-quality (low risk of bias) evidence on the impact of CR is needed to inform clinical guidelines and routine practice.

Trial registration: ClinicalTrials.gov NCT03270124 NCT03966417 NCT04166682 NCT03709511 NCT03801460 NCT02805309 NCT03470246 NCT00860678.

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Conflict of interest statement

Lizette Abraham declares no conflict of interest.

Kirstine L Sibilitz, Selina K Berg, Lars H Tang, Signe S Risom, Britt Borregaard, Jane Lindschou, Rod Taylor, and Ann‐Dorthe Zwisler are involved in conducting previous and/or current randomised clinical trials (including the included trial of Sibilitz et al) investigating the effects of cardiac rehabilitation for different cardiac populations. None of these trials were or are industry sponsored, but studies were sponsored by private and public funding. None of the founders had any involvement in analyses, collection of data, or interpretation of trial results.

Kirstine L Sibilitz and Ann‐Dorthe Zwisler are currently co‐authoring other Cochrane Reviews of cardiac rehabilitation.

Rod S Taylor is an author on previous Cochrane Reviews on cardiac rehabilitation and is the Chief Investigator for ongoing trials (REACH‐HFpEF, SCOT:REACH‐HF, DK:REACH‐HF) assessing the clinical effectiveness and cost‐effectiveness of home‐based self‐directed exercise‐based cardiac rehabilitation interventions for patients with heart failure and their carers.

Ann‐Dorthe Zwisler declares financial support for expert testimony as part of her employment as professor.

Figures

1
1
Updated study flow diagram.
1.1
1.1. Analysis
Comparison 1: Exercise versus no exercise, Outcome 1: All‐cause mortality at longest follow‐up
1.2
1.2. Analysis
Comparison 1: Exercise versus no exercise, Outcome 2: All‐cause mortality: best/worst‐case scenario
1.3
1.3. Analysis
Comparison 1: Exercise versus no exercise, Outcome 3: All‐cause mortality: worst/best‐case scenario
1.4
1.4. Analysis
Comparison 1: Exercise versus no exercise, Outcome 4: All‐cause hospitalisation at longest follow‐up
1.5
1.5. Analysis
Comparison 1: Exercise versus no exercise, Outcome 5: HRQoL (mental component) at end of intervention
1.6
1.6. Analysis
Comparison 1: Exercise versus no exercise, Outcome 6: HRQoL (physical component) at end of intervention
1.7
1.7. Analysis
Comparison 1: Exercise versus no exercise, Outcome 7: HRQoL (mental component) at maximum follow‐up
1.8
1.8. Analysis
Comparison 1: Exercise versus no exercise, Outcome 8: HRQoL (physical component) at maximum follow‐up
1.9
1.9. Analysis
Comparison 1: Exercise versus no exercise, Outcome 9: Exercise capacity (direct: VO2 max) at end of intervention
1.10
1.10. Analysis
Comparison 1: Exercise versus no exercise, Outcome 10: Exercise capacity (direct: VO2 max) at longest follow‐up
1.11
1.11. Analysis
Comparison 1: Exercise versus no exercise, Outcome 11: Exercise capacity (maximum measures) at end of Intervention
1.12
1.12. Analysis
Comparison 1: Exercise versus no exercise, Outcome 12: Exercise capacity (maximum measures) at longest follow‐up
1.13
1.13. Analysis
Comparison 1: Exercise versus no exercise, Outcome 13: Exercise capacity (indirect/submaximal: 6MWT) at end of Intervention
1.14
1.14. Analysis
Comparison 1: Exercise versus no exercise, Outcome 14: Exercise capacity (indirect/submaximal: 6MWT) at longest follow‐up
1.15
1.15. Analysis
Comparison 1: Exercise versus no exercise, Outcome 15: Serious adverse events
1.16
1.16. Analysis
Comparison 1: Exercise versus no exercise, Outcome 16: Return to work

Update of

References

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References to ongoing studies

ACTIVE AFTER TAVR 2017 {published data only}
    1. NCT03270124. A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement (ACTIVE AFTER TAVR): a pilot study. https://clinicaltrials.gov/ct2/show/NCT03270124 (first received 1 September 2017).
Exercise Training After TAVI {unpublished data only}
    1. NCT03966417. Exercise training after transcatheter aortic valve implantation (FitTAVI). clinicaltrials.gov/show/NCT03966417 (first received 29 May 2019).
Feng 2019 {published data only}
    1. ChiCTR‐IPR‐17011445. The effects of I stage cardiac rehabilitation on cardiopulmonary function in patients undergoing open heart surgery: a randomized controlled study. www.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR-IPR-17011445 (first received 2019).
HBCR‐TAVR 2019 {published data only}
    1. NCT04166682. Impact of home-based cardiac rehabilitation on outcomes after TAVR (HBCR-TAVR). https://clinicaltrials.gov/ct2/show/NCT04166682 (first received 18 November 2019).
Post Cardiac Valvular Surgery Rehabilitation (PORT {published data only}
    1. NCT03709511. Post cardiac valvular surgery rehabilitation (PORT). https://clinicaltrials.gov/ct2/show/NCT03709511 (first received 17 October 2018).
PREPARE TAVR Pilot Study {unpublished data only}
    1. NCT01504737. Rehabilitation in the form of exercise training in aortic stenosis patients (RASP). http://clinicaltrials.gov/show/NCT01504737 (first received 5 January 2012).
REHAB‐TAVR 2017 {published data only}
    1. NCT02805309. Home-based exercise program for recovery after transcatheter aortic valve replacement: a pilot study. https://clinicaltrials.gov/ct2/show/NCT02805309 (first received 20 June 2016).
The PACO Trial {published data only}
    1. Vasankari V, Jari Husu PY, Henri Tokola K, Jaana Sievanen H, Vesa Airaksinen J, Tommi Hartikainen J. Personalised eHealth intervention to increase physical activity and reduce sedentary behaviour in rehabilitation after cardiac operations: study protocol for the PACO randomised controlled trial. BMJ Open Sport & Exercise Medicine 2019;5(1):e000539. - PMC - PubMed
Valve‐ex 2009 {published data only}
    1. NCT00860678. Physical activity in patients after aortic valve replacement (Valve-ex). clinicaltrials.gov/ct2/show/NCT00860678 (first received 12 March 2009).
Wang 2019 {published data only}
    1. NCT04166682. Impact of home-based cardiac rehabilitation on outcomes after TAVR (HBCR-TAVR) [A study of the impact of home-based cardiac rehabilitation on outcomes after transcatheter aortic valve replacement (TAVR)]. clinicaltrials.gov/ct2/show/NCT04166682 (first received 18 November 2019).

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References to other published versions of this review

Sibilitz 2013b
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