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. 2017 Jul 14;2017(7):CD012015. doi: 10.1002/14651858.CD012015.pub2

Yoga for improving functional capacity, quality of life and cardiovascular outcomes in people with heart failure

Mahalaqua Nazli Khatib 1,✉, Richard Kirubakaran 2, Shilpa Gaidhane 3, Anuraj H Shankar 4, Zahiruddin Quazi Syed 5
PMCID: PMC6483289

Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To assess the efficacy and safety of yoga therapy on mortality, functional capacity, quality of life (QoL) and cardiovascular outcomes in people with heart failure.

Background

Description of the condition

Heart failure (HF) is a complex clinical condition that develops as a consequence of structural or functional impairment of ventricular filling or ventricular ejection of blood (Yancy 2013). It affects over 23 million people worldwide and is expected to become a major public health issue in low‐ and middle‐income countries (Go 2013; Khatib 2014a; Khatib 2014b; Khatibzadeh 2013). The burden of HF is high in East Asia with a prevalence of 1.3% to 6.7% (Guo 2013). In developed countries, approximately 1% to 2% of the adult population suffers from HF (McMurray 2012). Data from the Framingham Heart Study indicates that the incidence of HF increases with age (Ho 1993; Yancy 2013). It increases from approximately 20/1000 individuals between 65 to 69 years of age to more than 80/1000 individuals among those over 85 years of age (Curtis 2008; Yancy 2013). Although survival of people with HF has improved, the mortality rates within five years of diagnosis still remain approximately 50% (Yancy 2013). Apart from significant mortality, HF has high readmissions morbidity and high health costs (Khatib 2015a; Lee 2012). It is the primary diagnosis in more than one million hospitalisations annually with high readmission rates and prolonged inpatient stays which places a substantial burden on the healthcare system (Go 2013; Krumholz 2009; Yancy 2013). In many high‐income countries; HF typically consumes 1% to 2% of the healthcare resources (Bui 2011; Go 2013; Liao 2008; NICE Clinical Guidelines 2010; Stewart 2002). Analysis of 197 countries; covering approximately 98.7% of the world's population estimated the overall economic cost of HF in 2012 as 108 billion USD per annum (Cook 2014). Spending on HF varies widely between low‐income, middle‐income and high‐income countries (Cook 2014). Epidemiology and costs of HF still remain poorly described in most regions of the world (Bui 2011; Khatibzadeh 2013).

People with HF usually experience worsening of symptoms over time punctuated by episodes of frank decompensation between periods of stability (Huang 2010; McMurray 2012). HF is characterised by physical symptoms of dyspnoea and fatigue. This causes exercise intolerance and retention of fluid thereby leading to pulmonary or splanchnic congestion or peripheral oedema, or a combination of these conditions (Yancy 2013). These physical symptoms cause limitations in several aspects of people’s daily lives and negatively influences health‐related quality of life (HRQoL) (Carlson 2001; Gorkin 1993; Heo 2008; Todero 2002). About 80% of people with HF exhibit dyspnoea and fatigue during daily activities, and about 20% have dyspnoea and fatigue even at rest (Lainscak 2003). More specific symptoms like orthopnoea and paroxysmal nocturnal dyspnoea are less common (McMurray 2012). Therefore, goals in the treatment of HF should be to increase survival, relieve symptoms, increase functional capacity, improve prognosis, prevent hospital admission and improve quality of life.

Current therapy for HF comprises an array of drugs, devices and cardiac rehabilitation (Taylor 2014). Decades of clinical research on reducing hospitalisation and mortality associated with HF have finally included these therapies in international guidelines (Clinical Practice Guidelines 2014; McMurray 2012; NHFA 2011; NICE Clinical Guidelines 2010; Rajadurai 2014; Reddy 2010; SIGN 2007; Yancy 2013). Though these agents have improved the symptoms of HF, the mortality rate still remains high, prognosis is still poor and quality of life is still significantly impaired.

Description of the intervention

With a need for alternative or further treatment strategies, several non‐pharmacological interventions have surfaced and have created a new challenge in the treatment of HF (Gomes‐Neto 2014; McMurray 2012; Pan 2013). One such non‐pharmacological intervention is yoga. It is a psychosomatic‐spiritual discipline with mind‐body (psychological and physical) techniques characterised by integration of physical poses (asanas), breathing exercises (pranayama) and meditation (dhyana) that can be efficiently used to promote physical and mental well‐being i.e. a 'healthy body with a sound mind' (Büssing 2012; Gangadhar 2015; Lin 2015). Practising asanas improves flexibility and strength of the muscles. Pranayama is an important component of relaxation and a regulator of autonomic nervous function (Krishna 2014b; Sinha 2013). Practising meditation has been shown to calm the mind (Balaji 2012). The concept of yoga was founded in India over 5000 years ago and is now not only popular in India but also in Western countries (Balaji 2012).

Yoga practices have shown diverse medical benefits. It has been used in the treatment of stroke (Desveaux 2015; Immink 2014; Lazaridou 2013; Schmid 2012); chronic obstructive pulmonary disease (Desveaux 2015; Fulambarker 2012; Soni 2012); asthma (Glickman‐Simon 2013; Kant 2014; Sodhi 2014); depression (Battle 2015; Desveaux 2015; Falsafi 2015); breast cancer (Long 2015; Peppone 2015; Rahmani 2015; Rao 2015; Yagli 2015); diabetes mellitus (Chimkode 2015); metabolic syndrome (Anderson 2011; Kanaya 2014; Siu 2015); low back pain (Aboagye 2015; Crow 2015; Lee 2014); mood disorders (Pascoe 2015).

Yoga therapy also demonstrates a range of beneficial effects in cardiovascular diseases (Cramer 2014; Manchanda 2014; Natarajan 2015). When combined with other lifestyle modifications, it has shown promising results in improving lipid profiles (Raghuram 2014; Wiwanitkit 2011; Yadav 2014); hypertension (Thiyagarajan 2015; Tyagi 2014; Wolff 2013); coronary heart disease (Pal 2013; Yadav 2015); cardiac dysrhythmia (Dabhade 2012; Lakkireddy 2013); and heart failure (Cramer 2015; Howie‐Esquivel 2010; Krishna 2014a; Krishna 2014b; Kubo 2011; Pullen 2008; Pullen 2010; Selman 2015).

How the intervention might work

A range of significant benefits of yoga on physiological, behavioural and psychological factors have been proposed (Balaji 2012). Clinical trials on people with HF have demonstrated supplementary advantage of Yoga therapy along with standard medical therapy (SMT). These trials have shown that yoga, in addition to providing symptom stability for people with HF (Howie‐Esquivel 2010), improves exercise tolerance (Pullen 2008), cardiovascular endurance (Pullen 2010; Lau 2015), cardiac function (Krishna 2014b), autonomic function (Krishna 2014a), inflammatory markers (Pullen 2008; Pullen 2010), and quality of life (QoL) (Gomes‐Neto 2014; Kubo 2011; Pullen 2008; Pullen 2010). It also reduces myocardial stress (Krishna 2014b); and depression (Kubo 2011). Overall, yoga promotes health‐related quality of life by improving psychological and physical symptom status.

Regardless of the cause, HF is associated with neuro‐hormonal, musculoskeletal and haemodynamic abnormalities. Increased neuro‐hormonal activation via the sympathetic nervous system and renin‐angiotensin system has been implicated in the progression of HF. Postural exercises, controlled breathing and meditation components of yoga have been shown to reduce reactivity of the sympathoadrenal system (Innes 2007), modulate the hypothalamic‐pituitary‐adrenal system (Innes 2007; Pascoe 2015), and improve baroreflex sensitivity (Krishna 2014b). Pranayamic breathing exercises stretch the lung tissue. Stretching of alveoli stimulates the slowly adapting stretch receptors of the lungs which sends inhibitory signals to the cardio‐inhibitory area in the medulla oblongata. Inhibitory signals involve the vagus nerve with resultant dominance of parasympathetic activity (Jerath 2006; Sinha 2013). Other possible mechanisms include counteracting an aroused autonomic nervous system activity and putting it back to a relaxed state (Michalsen 2005). Thus yoga may cause physio‐psychological changes by shifting the autonomic equilibrium towards parasympathetic dominance and improving baroreflex sensitivity thereby leading to reduction in heart rate and blood pressure, which significantly impacts HF (Krishna 2014b; Sinha 2013).

Yogic practices have been shown to decrease ventricular filling pressures (Pullen 2010), and reduce stress on the myocardium (Krishna 2014b). Improvement in cardiac function and myocardial stress can translate into reduced mortality rates. Better functioning of the intercostal muscles resulting from increased muscular endurance by yoga enhances VO₂max and facilitates effective extraction of oxygen by the peripheral tissues (Lau 2015).

Studies have demonstrated the feasibility of the yoga programme by high attendance rate and positive feedback from participants, thereby suggesting that yoga may be an alternative modality for health enhancements (Howie‐Esquivel 2010; Lau 2015).

Why it is important to do this review

Despite widespread clinical acceptance and demonstration of therapeutic potential of yoga, there is uncertainty about its precise therapeutic efficacy. Also, the quality of evidence for incorporating it in the management of HF has not been established and it is not included in therapeutic guidelines for HF. Systematic reviews focusing on prevention of cardiovascular diseases have been published (Cramer 2014; Hartley 2014). Cramer 2015 examined the quality of evidence and strength of recommendations for yoga on outcomes of mortality, exercise capacity and HRQoL in people with HF. However, in our review, apart from the outcomes reported by Cramer 2015 we intend to explore the efficacy of yoga on outcomes of HF‐related hospitalisations, adverse events, cardiovascular biomarkers, NYHA functional classification of clinical status, cardiovascular outcomes, and costs. The systematic review by Lau 2012 and its update by Kwong Kwong 2015 have been published in the Cochrane Database of Systematic Reviews (CDSR) with an objective of determining the effect of yoga for prevention of mortality, morbidity and HRQoL in people with coronary heart diseases.

There is still a need for a comprehensive systematic review to critically evaluate up‐to‐date evidence and determine whether yoga is effective in people with HF. In this review, we intend to summarise all the available literature and determine the safety and efficacy of yoga in improving functional capacity, quality of life and cardiovascular outcomes in people with HF. This review can be of help to policy‐makers, heart associations and physicians to decide whether yoga can be incorporated as a complementary therapy for HF. If the quality of evidence proves insufficient, this review will explore the grey area of research as a basis for future clinical trials.

Objectives

To assess the efficacy and safety of yoga therapy on mortality, functional capacity, quality of life (QoL) and cardiovascular outcomes in people with heart failure.

Methods

Criteria for considering studies for this review

Types of studies

We will include parallel or cross‐over randomised controlled trials (RCTs) examining the beneficial or harmful effects of any type of yoga in people with HF. We will not restrict study eligibility by language or publication status.

Types of participants

We will include studies on individuals of 18 years and over satisfying New York Heart Association (NYHA) or Framingham criteria for HF. We will consider including people regardless of NYHA stage and also people newly diagnosed with HF. We will include people with HF regardless of its primary cause (rheumatic/valvular) and type (systolic/diastolic HF; acute/chronic HF). People with HF alone as well as with other co‐morbidities will be included in the review. We will not apply restrictions on gender or ethnicity.

Types of interventions

We will include studies of any type of yoga intervention as an adjunct to standard medical care for HF compared to a control group receiving standard medical care alone (without yoga) or an intervention other than yoga. Studies with any standard medical care for HF would be acceptable for inclusion in the review.

We will not restrict studies according to the type of yoga. We will focus on length of yoga of two months or more and follow‐up period of two months or more. The rationale for choosing two months' intervention and follow‐up is taken from the Guidelines for Developing Yoga Interventions for Randomized Trials (Sherman 2012).

We will include studies comparing yoga plus standard care versus standard care alone. Concomitant interventions will be permitted as long as they are provided in both the intervention and control group.

(The standard medical therapy for people with HF (both with preserved ejection fraction and with reduced ejection fraction) includes disease‐modifying therapies like angiotensin‐converting enzyme inhibitors (ACE‐I) or angiotensin receptor blocker (ARBs), beta‐blockers, mineralocorticoid receptor blocker (aldosterone antagonist) and diuretics (Yancy 2013). Additionally, drugs may also be used to treat other co‐morbid conditions that may lead to, or contribute to, HF, such as obesity, diabetes mellitus and hypertension.)

Types of outcome measures

Primary outcomes

The main outcome measure will be improvement of HF reflected by reduction in:

  1. Cardiovascular mortality

  2. Heart failure‐related hospitalisation; and

  3. Number of adverse events reported.

Secondary outcomes

The secondary outcomes in the review will be:

  1. Cardiovascular biomarkers like changes in brain natriuretic peptide (BNP) levels, N‐terminal pro B‐type natriuretic peptide (NT‐proBNP) and cardiac troponin levels and ghrelin levels.

  2. Functional capacity as measured by 6 minutes' walk test (6MWT).

  3. NYHA functional classification of clinical status.

  4. Cardiovascular outcomes like changes in heart rate (HR in beats/min), arterial blood pressure (systolic blood pressure, diastolic blood pressure and mean arterial blood pressure in mmHg) and left ventricular fraction (LVEF in %).

  5. Quality of life (QoL) as measured by The Minnesota Living with Heart Failure questionnaire (MLWHFQ).

  6. Costs

Reporting of any of these outcome measures will not form part of the criteria for including studies in a review.

Search methods for identification of studies

Electronic searches

We will identify trials through systematic searches of the following bibliographic databases:

  • Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library

  • MEDLINE (Ovid)

  • EMBASE (Ovid)

  • PsycINFO (Ovid)

We will use Medical Subject Headings (MeSH) and text word terms and tailor the search to individual databases. The preliminary search strategy for MEDLINE (Ovid) (Appendix 1) will be adapted for use in the other databases. We will use keywords and synonyms to sensitise the search.

We will search the Indian medical literature via the Indian Council of Medical Research (ICMR) and IndMED database. We will also conduct a search of clinical trials registers (www.ClinicalTrials.gov), the WHO International Clinical Trials Registry Platform (ICTRP) Search Portal (http://apps.who.int/trialsearch/) and websites of the Yoga Biomedical Trust (http://yogatherapy.org/), Research Council for Complementary Medicine (http://www.rccm.org.uk/) and Ministry of AYUSH (www.indianmedicine.nic.in).

We will search all databases from their inception to the present, and we will impose no restriction on language of publication status.

Searching other resources

We plan to carry out handsearches for international abstracting publications of conference proceedings (traditional and alternative medicines, mind‐body medicine) and medical journals (Journal of Yoga and Physical Therapy; International Journal of Yoga Therapy; Yoga). We will check reference lists of all primary studies and review articles for additional references. We will contact yoga experts to find out any unpublished studies or published studies in non‐indexed journals and details of ongoing trials on yoga interventions for people with HF. We also intend to search for trial information on websites of relevant yoga centres like Central Council for Research in Yoga and Naturopathy (www.ccryn.org), Central Council for Research in Ayurvedic Sciences (http://www.ccras.nic.in/), Siddha Central Research Institute (www.crisiddha.tn.nic.in), Iyengar Yoga Centre (http://iyi.org.uk/), International Sivananda Yoga Vedanta Centres (http://www.sivananda.org/), The Yoga Institute, Mumbai (http://theyogainstitute.org/), International Centre for Yoga Education and Research (http://www.icyer.com/).

Data collection and analysis

Selection of studies

Two review authors (MNK, SG) will independently screen titles and abstracts for inclusion of all the potential studies identified as a result of the search. We intend to use Rayyan online screening tool (Rayyan 2014). If there are any disagreements about the eligibility of the retrieved study, a third author (ZQS) will be asked to arbitrate. We will retrieve the full‐text publication and two review authors (MNK, SG) will independently screen the full‐text, identify studies for inclusion, and identify and record reasons for exclusion of the ineligible studies. We will resolve any disagreement through discussion or consultation with a third reviewer (ZQS). We will identify and exclude duplicates and collate multiple reports of the same study so that each study rather than each report is the unit of interest in the review. We will record the selection process in sufficient detail to complete a PRISMA flow diagram and 'Characteristics of excluded studies' table.

Data extraction and management

For studies that meet the inclusion criteria, we will abstract data using a data collection form for study characteristics and outcome data which has been piloted on at least one study in the review. Two review authors (MNK, SG) will extract study characteristics from included studies. We will extract the following study characteristics:

  1. Methodological/trial design: study design, method of randomisation, method of allocation concealment, total duration of study, details of any 'run‐in' period, study setting, withdrawals, duration of treatment period, duration of follow‐up, information on sponsorship/funding.

  2. Participants: number of participants allocated to each treatment group, mean age/age range, gender distribution, diagnostic criteria, severity of HF, inclusion and exclusion criteria.

  3. Interventions: total number of intervention groups with number of participants in each group, type, duration and frequency of intervention, presence of supervision, comparison, concomitant medications and excluded medications.

  4. Outcomes: number of participants with each outcome per group will be noted. Primary and secondary outcomes will be specified and collected, and time points will be reported.

The details of included health economics studies will be extracted and described in the ‘Characteristics of included studies’ table. We will state the currency and price year alongside estimates of costs.

Two review authors (MNK, SG) will independently extract outcome data from included studies. We will resolve disagreements by consensus or by involving a third person (AS). One review author (MNK) will transfer data into the Review Manager 5 (RevMan 2014) file. We will double‐check that data is entered correctly by comparing the data presented in the systematic review with the study reports. A second review author (ZQS) will spot‐check study characteristics for accuracy against the trial report.

Assessment of risk of bias in included studies

Two review authors (MNK, RK) will independently assess risk of bias for each study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We will resolve any disagreements by discussion or by involving another author (AS). We will assess the risk of bias according to the following domains:

  1. Random sequence generation.

  2. Allocation concealment.

  3. Blinding of outcome assessment.

  4. Incomplete outcome data.

  5. Selective outcome reporting.

  6. Other bias.

Since blinding of participants and personnel is not applicable for yoga, we will not include this in the risk of bias. We will grade each potential source of bias as "high", "low" or "unclear" and provide a quote from the study report together with a justification for our judgment in the 'Risk of bias' table. We will summarise the risk of bias judgments across different studies for each of the domains listed. Where information on risk of bias relates to unpublished data or correspondence with a trialist, we will note this in the 'Risk of bias' table. When considering treatment effects, we will take into account the risk of bias for the studies that contribute to that outcome.

Assessment of bias in conducting the systematic review

We will conduct the review according to this published protocol and report any deviations from it in the 'Differences between protocol and review' section of the systematic review.

Measures of treatment effect

We will conduct meta‐analysis for individual studies and report pooled statistics as odds ratios or risk ratios with 95% confidence intervals (CI) for dichotomous data and mean difference or standardised mean difference with 95% CI for continuous data. We will enter data presented as a scale with a consistent direction of effect. We will narratively describe skewed data reported as medians and interquartile ranges.

Unit of analysis issues

Cross‐over and parallel RCTs will be included in the review. While incorporating cross‐over trials into a meta‐analysis; we will follow the approach suggested by Elbourne 2002.

Dealing with missing data

We will contact investigators or study sponsors in order to verify key study characteristics and obtain missing numerical outcome data where possible (e.g. when a study is identified as abstract only). Where this is not possible, and the missing data are thought to introduce serious bias, we will explore the impact of including such studies in the overall assessment of results by a sensitivity analysis.

Assessment of heterogeneity

We will analyse statistical heterogeneity through Chi² test (P value < 0.10) and use I² statistic to measure heterogeneity among the trials in each analysis. Heterogeneity will be regarded as considerable if I² is more than 75%; substantial if it is between 50% to 90%; moderate if it is between 30% to 60%; and mild if less than 40% (Higgins 2011). If we identify substantial or considerable heterogeneity, we will report it and explore possible causes by prespecified subgroup analysis.

Assessment of reporting biases

If we are able to pool more than 10 trials, we will create and examine a funnel plot to explore possible small study biases for the primary outcomes.

Data synthesis

For meta‐analysis, we will use a random‐effects model in the presence of considerable (I² > 50%) or substantial clinical heterogeneity (I² > 75%). In the absence of heterogeneity (I² < 50%), we will apply a fixed‐effect model. We will undertake a meta‐analysis only if participants, interventions, comparisons and outcomes can be judged to be sufficiently similar to ensure an answer that is clinically meaningful. If studies are very heterogenous, we will summarise the data narratively and not pool the results of the included studies. For dichotomous variables, we will compute treatment effects as risk ratios (RR) with 95% CI. For continuous variables, we will calculate differences in means and their 95% CI. If estimates of costs for yoga and its comparator group are available from included studies, then these will be pooled. Cost estimates collected from different studies will be adjusted to a common currency and price year before pooling the data. For analysis, we plan to use RevMan 2014.

Summary of findings table

We will create a 'Summary of findings' table using the following outcomes: cardiovascular mortality; HF‐related hospitalisations; number of adverse events; functional capacity; cardiovascular outcomes; and quality of life (QoL). We will use five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of the body of evidence as it relates to the studies which contribute data to the meta‐analyses for the prespecified outcomes. We will use methods and recommendations described in Section 8.5 and Chapter 12 of the Cochrane Handbook for Systematic Reviews of Interventions using GRADEpro software (Higgins 2011). We will justify all decisions to down‐grade or up‐grade the quality of studies using footnotes and we will make comments to aid the reader's understanding of the review where necessary.

Subgroup analysis and investigation of heterogeneity

We plan to carry out the following subgroup analyses:

  1. Type of yoga

  2. Dose of yoga

  3. HF alone versus HF plus co‐morbidities.

We will use the following outcomes in subgroup analyses:

  1. Functional capacity

  2. Quality of life

  3. Cardiovascular outcomes (heart rate, blood pressure, ejection fraction)

We will use the formal test for subgroup interactions in RevMan 2014.

Sensitivity analysis

We plan to carry out the sensitivity analysis by including studies with a low risk of bias.

Reaching conclusions

We will base our conclusions only on findings from the quantitative or narrative synthesis of included studies for this review. We will avoid making recommendations for practice and our implications for research will suggest priorities for future research and outline what the remaining uncertainties are in the area.

Acknowledgements

We thank Dr Abhay M Gaidhane for editing the protocol.

Appendices

Appendix 1. Preliminary MEDLINE (Ovid) search strategy

Draft MEDLINE strategy

1. Yoga/

2. Relaxation Therapy/

3. yoga.tw.

4. asan*.tw.

5. pranayam*.tw.

6. dhyana.tw.

7. Meditation/

8. meditat*.tw.

9. hatha.tw.

10. ananda.tw.

11. ashtanga.tw.

12. bikram.tw.

13. iyengar.tw.

14. kripalu.tw.

15. kundalini.tw.

16. sivananda.tw.

17. vinyasa.tw.

18. Mind‐Body Therapies/

19. mind body.tw.

20. MBM.tw.

21. Mindfulness/

22. mindful*.tw.

23. or/1‐22

24. exp Heart Failure/

25. ((heart or cardiac) adj2 insuff*).tw.

26. exp Ventricular Dysfunction/

27. ((heart or cardiac or myocard* or ventric*) adj2 fail*).tw.

28. ventric* dysfunction*.tw.

29. (heart adj decompens*).tw.

30. or/24‐29

31. 23 and 30

What's new

Date Event Description
14 July 2017 Amended This protocol has been withdrawn as the author team is unable to progress to the final review stage. This title is not open to a new author team as it is considered low priority.
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Contributions of authors

MNK and ZQS drafted the protocol with clinical and methodological input from RK, SG and AS.

Sources of support

Internal sources

  • Datta Meghe Institute of Medical Sciences, India.

External sources

  • No sources of support supplied

Declarations of interest

MNK: None known

RK: None known

SG: None known

AS: None known

ZQS: None known

Notes

This protocol has been withdrawn as the author team is unable to progress to the final review stage. This title is not open to a new author team as it is considered low priority.

Withdrawn from publication for reasons stated in the review

References

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