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Научни трудове на Съюза на учените в България-Пловдив, серия Г. Медицина, фармация и дентална медицина t.XVI. ISSN 1311-9427. Научна сесия „Медицина и дентална медицина", 31 Октомври - 1 Ноември 2014. Scientific researches of the Union of Scientists in Bulgaria-Plovdiv, series G. Medicine, Pharmacy and Dental medicine, Vol.XVI, ISSN 1311-9427 Medicine and Stomatology Session, 31. October- 1. November 2014.
CONTINIOUS TRAINING MODES IN BULGARIAN CHRONIC HEART FAILURE PATIENTS INVESTIGATING THE EFFECTS OF GROUP BASED HIGH-INTENSIVE AEROBIC INTERVAL AND MODERATE
Jannnis V. Papathanasiou Department of Physical and Rehabilitation Medicine Medical University of Plovdiv, Bulgaria
Introduction
Heart failure continues to be one of the leading causes of morbidity and mortality among adults and its increasing frequency remains a global trend. Despite a lot of evidence in current medical literature concerning group based cardiac-rehabilitation (CR) models upon functional capacity, quality of life (QoL) and cost effectiveness, these training models in Bulgaria rarely apply12.
The interpretations of this phenomenon in Bulgaria it is due to the lack of a coherent health policy over the past 20 years, ignoring the growing cardiologic incidence and deploying its priorities in other areas of public health. On the other hand, the small number of well-organized and modernly equipped outpatient CR centers lead to severe restriction of user access to these services, which greatly limit the ability to conduct randomized controlled studies(RST's), aiming to objectify the effects and the impact of the different CR interventions3.
OBJECTIVE:To evaluate the effect of the application of two different CR interventions on the functional capacity and the QoL in patients with CHF.
TASKS:To achieve the purpose of this thesis the following tasks have to be resolved:
1. Application of a modified high intensive interval aerobic interval CR training program m-Ulleval and a moderate intense continuous training.
2. Comparison of the functional capacity of patients with CHF prior to and after two diverse interventions by considering the actual oxygen consumption during the 6MWT with portable gasexchange analyzers.
3.Investigating the effect of both CR training models upon the level of serum cytokines(TNFa, acute-phase CRP) and adhesion molecules (sICAM, sVCAM).
4. Research of the effects of both CR training modes on the QoL of patients with CHF.
MATERIAL AND METHODS: In our prospective randomized controlled trial (RCT), seventy-five (n=75) eligible patients were included (age: 64,28 ± 6,25 years) with stable CHF, New York Heart Association classes II to IIIB, in a 12-week CR program. Included individuals were on optimal medical treatment consisting of p-blockers and angiotensin-converting enzyme (ACE) inhibitors etc. Ischemic cardiomyopathy (58,7%), hypertensive heart failure (26,7%), and idiopathic dilated cardiomyopathy (14,7%), were the causes of CHF .
The inclusion and exclusion criteria for of patient selection in our study can be are seen in Table 1.
Table ^Inclusion and Exclusion Criteria
Inclusion criteria Exclusion criteria
• Coronary disease (myocardial miarction after its 12th week, chronic stable angina) • LVEF < 40% • Chronic compensated heart failure • 6-MWT < 550m • Aortocoronary bypass surgery • Angioplasty PCI • Replacement of the valve • Heart transplantation • Benign controlled arrhythmia • Patients with pacemakers • Hypertensive patients • Dyslipidemia, obesity • Unstable angina pectoris • Recent myocardial infarction <4 weeks • Resting systolic hypertension > 200 mm Hg • Resting diastolic hypertension > 110 mm Hg • Heart failure IV class NYHA • Uncontrolled ventricular & supraventricular arrhythmias • Average grade or high-grade aortic stenosis • Hypertrophic obstructive cardiomyopathy • Blood glucose <80 . or >300 pg /dl; • Recent pulmonary embolism • Recent thrombophlebitis • Acute chronic infection • Autoimmune disease or immune deficiency
The study was approved by the Regional Committee for Medical Research Ethics. Informed written consent was obtained from all included subjects.
Patients were randomly assigned to two main CR groups: One group (n=38) performed the m-Ullevaal model-high intensive aerobic interval training model (HIAIT) and the second group (n=37) performed moderate intensive continuous training (MICT) in cycle ergometers. In
order to achieve optimal results, each major training group was subdivided into six subgroups consisting of 5 to 8 individuals. All subjects were evaluated at baseline (T1), and after 24 sessions of exercise training (after 12 weeks; T2).The primary outcome was functional capacity, evaluated by the 6-minute walking distance test (6MWDT).
Six minute walk test
The 6MWT is a widely used tool for measuring the response to various CR interventions, due to its easy implementation and better acceptanceby the patients when compared with other field tests (shuttle walking test, and the 200-meter fast walk test)4. The test was performed in a marked corridor 30 m in length, and patients are instructed to walk from one end to another at their own pace, attempting to cover as great distance as possible in 6 minutes. It's proven that the results from the 6MWT is also a strong independent prognostic indicator of one-year free survival and mortality of CHF patients5,6.
Measurements. Gas exchanges were measured during the 6MWT test (V02000 Med Graphis, St Paul, Minnesota, USA). This device provided measurements of peak VO2 AT, RER and VE)78. '
Modified Borg scale
In our study we applied the modified Borg scale described by Kendrick et al. It is a self-assessment scale of perceived exertion with values ranging from 1 to 10 points. During each minute of the 6MWT, the subjects were asked to rate their perceived exertion on the modified Borg scale9. The participants in the m-Ullevaal group during the high-intensity intervals were encouraged to reach 5-7 points on the modified Borg scale, and 2-4 points during the moderate intense intervals.
Quality of Life
Quality of life was assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) as originally designed by Rector et al10. This health related questionnaire consists of 21 items recording patient perceptions of how CHF affects their physical, psychological and socioeconomic lives. The overall scale ranges from 0 to 105 (lower scores indicate a better QoL)11.
The CR Ullevaal model - The CR Ullevaal model is a group based aerobic interval training, widely applied in Scandinavian countries, especially among patients with CHF12-14. Subjects perform simple aerobic dance movements involving upper and lower extremities in order to achieve postural control. Each interval includes coordination exercises. A specialist in physical and rehabilitation medicine (PRM) must be present in the center of the training group while demonstrating the various exercises to the patients 215. The concept and purpose of this model is not only to improve exercise capacity in patients with CHF, but also to improve their psychological and emotional status, as well as to improve their limited activities of daily living (ADL).16
Music: Fifteen specially selected musical pieces where used in m-Ullevaal to support and regulate the intensity of each CR mode.
RESULTS AND DISCUSSION
Our modifications of the CR Ullevaal model
The following modifications have been made to the CR Ulevaal model:
1. We reduced the duration of the model from 16 weeks to 12 weeks.
2. Keeping the same training sessions per week, we reduced the overall duration of training sessions from 50 to 40 minutes.
3. Each training session consists of three high-intensity intervals (HRmax: 90%). We added strength exercises in the high intensity intervals. There were also two intervals of moderate intensity (HRmax: 70%).
4. We kept the mean duration of each interval between 5 and 10 minutes.
5. We optimized the number of participants; each subgroup consisted of 5 to 8 individuals as opposed to 8-12 included in the original model.
6. We applied the modified Borg's scale (CR-10).
7. We reduced the number of consultations (n=12) while we increased the duration of each consultation to 45-60 min.
warm up and cool down intervals: The m-Ullevaal CR model includes a warm up and a cool down intervals. During warm-up intervals, exercises addressed to the large muscle groups are performed, as they are preparing for vigorous exercises performed in subsequent intervals with a maximum range of motion (ROM). Slow and progressive decrease in exercise intensity during the cool down intervals was achieved with slow walking after the third high intensity interval12.
In high intensity intervals we applied the same exercise set as in the original described model, while during the moderate intensive intervals push-ups, curl up, flexed on knees and quadruped exercises were excluded.
Education: As an integral part of the model at the end of each week, a nurse implemented a total of twelve counseling lectures to the group, focused on the control and interpretation of the symptoms of CHF, the physical activity and the proper diet. The duration of each consultation is 30 to 60 minutes. Patients, who have expressed greater interest, received individual consultations17.
Table 2.Training time adherence participants to both CR interventions
CR interventions # of Training Sessions Compliance Total training time (hrs)
MICT 21.04±1.89 87.67% 14.05±1.26
HIAIT (m-Ullevaal) 21.16±1.71 88.17% 14.11±1.14
Compliance (actually performed training sessions divided by possible ones) was 88,17% which corresponds to 21,16 ± 1,71 of scheduled training sessions in the m-Ullevaal group. Respective values in the MICT group were 87,67% and 21,04 ± 1,89 (Table 2).
Our study is the first application of a supervised group-based CR Ullevaal model conducted in Bulgaria. Our results showed that the m-Ullevaal group had a 14.53% improvement in walking
distance (6MWT= (63m) as compared with the 10.06 % improvement (44m) in the MICT group18 (Table 3).
Table3. Functional Capacity (6MWT) in CR groups before and after CR interventions
Training Groups HIAIT (m-Ullevaal) Ullevaal P
Variable Baseline (T1) Follow up (T2) A(%) Baseline (T1) Follow up (T2) A(%)
6MWT (m) 443,2±42,9 506,3±39,3 14,5±4,7 457±77 515±93 (58m) 13% <0,001
Effect of physical training on biomarkers of inflammation
In present randomized control trial (RCT) revealed higher levels of soluble cell adhesion molecules (iCAM -1 and vCAM -1) in all included individuals with CHF NYHA stages II and III, regardless of gender and age (P> 0.05) compared with the reference range given by the manufacturer of the kits used, Bender MedSystems GmbH (Vienna, Austria).
Table 4. The initial serum concentrations of tested parameters in both CR groups
Parameters Initial values Reference range
HIAIT (X±SD) MICT (X±SD)
hsCRP (ng / ml) 816,85 ± 97,61 810,62 ± 99,65 136-800
TNF-a (pg / ml) 59,58 ± 8,99 59,06 ± 8,37 5-66
iCAM-1 (ng / ml) 404,91 ± 38,88 413,85 ± 47,49 129.9-297.4
vCAM-1 (ng / ml) 1291,36 ± 128,50 1295,97 ± 125,96 400.6-1340.8
Significant intra and inter-group changes were observed in proinflammatory marker CRP, at the exprese of higher reported reduction in its levels in HIAIT20. In the beginning of the CR interventions it varies within levels 816.85 ± 97.61 ng/l, and after twelve weeks of high-intensity
CR program the same marker dropped by 5.42%. which was significant (p <0.001 /), (Fig. 1)
I I
1 p<0,001 1
820 n
c<0.00
□ initial value
□ final value
HIAIT
MICT
Figurel. Change in hsCRP in both CR programs - HIAIT and MICT.
Smaller but significant changes were established in hsCRP for the MICT group too, where its levels ranged from 810.62 ± 99.65 ng/l, and its change in percentage was 4.95%, (p <0.001). Another pro-inflammatory marker that has been studied in both CR groups, TNF-a, also showed significant dynamics, both intragroup and betweengroup. Mechanisms for the reduction of the levels of TNF-a are not clarified enough; probably they include reduction of training induced hypoxia21. A significant decrease in its levels were seen in the group performing the HIAIT program, where the changes in this group reached 29.71% and are significantly greater than what the MICT group achieved (22.35%). For both CR interventions the interclass reduction was significant (p <0.001), (Figure 2).
Figure 2. TNF-a changes in both CR interventions - HIAIT and MICT.
Significant increase in the levels of pro-inflammatory cytokines - CRP and TNF-a, was observed more frequently in individuals with dilated cardiomyopathy (P <0.05). Changes in serum levels were observed in the CAMs. A statistically significant reduction was established in the levels of iCAM-1 in both CR models - HIAIT and MICT for a 12 week period, as within-group (iCAM -1 initially - 404.91 ± 38.88ng/ml, iCAM -1 in the 12th week 342.67 ± 39.18 ng/ml, p <0.001), as well as inter-group (p <0.001).Both CR groups - HIAIT and MICT showed statistically significant decrease in vCAM-1 levels for a 12-week period as within-group (HIAIT - vCAM -1 initially -1291.36 ± 128.50ng/ml, iCAM -1 levels in the 12th week 1146.36 ± 128.50ng/ml, p <0.001; MICT - vCAM -1 initially - 1295.97 ± 125.96ng/ml, iCAM -1 in the 12th week 1164.97 ± 125.96 ng / ml, p <0.001), as well as between-group (p <0.001).
Figure 3. Changes in iCAM-1 in both CR interventions - HIAIT and MICT.
1350 1300 [250 [200 [150 [100 1050
P<0jQDl
1
f-JU.yjl
—
-
p initial us
HIAIT
MICT
Figure 4.Changes in vCAM-1 in both CR interventions - HIAIT and MICT.
Quality of Life
All the included individuals (n = 75) of our study completed twice the MLHFQ - at the first and at the last training session of the 12-week CR program. Non-statistically significant data from this study show that the MLHFQ scores in the initial period of the two CR groups were different in comparison to those obtained in the final training period.The MLHFQ scores in both groups showed improvement by 17.26% ± 3.78 and 6.42% ± 3.06, respectively.The initial MLHFQ scores obtained by the study in the HIAIT group were; 37.37 ± 6.66, and in the MICT group - 38.27 ± 8.44. In the final training period as a result of the ongoing CR interventions the MLHFQ scores obtained were; 30.92 ± 6.54 for HIAIT and 35.81 ± 8.56 for MICT, respectively. Improving the QoL was statistically significant in both groups, but for the HIAIT group it is several times greater (P <0.001) (Table 5).
Table 5.Improvement in Qol and 6MWT
Training Groups HIAIT A (%) MICT A (%) P value
Variable Baseline (T1) Follow-up A (%) Baseline (T1) Follow-up <0.001
MLHFQ score 37,37±6,66 30,92±6,54 - 17,26±3,78 38,27±8,44 35,81±8,56 - 6,42±3,06 <0.001
The nominal change of MLHFQ scores for the two CR groups show an overall average increase of 6.45 points in the HIAIT group and 2.46 points in the MICT group. According to T.S. Rector, change in assessment scores by 5 points can be considered clinically significant, allowing conclusions to be drawn about the clinical relevance and effectiveness of HIAIT10. Significant improvement in QoL by HIAIT is confirmed by the obtained MLHFQ scores, which is analogous to the objective measure 6MWT, in which the individuals covered more than 500 m upon completion of the CR intervention.The results show that significant and strong influence was mainly exerted by the CR mode of intervention (r = 0.726, p <0.001). Single-factor analysis of variance (ANOVA) shows that it is a significant factor in the changes in scores for QoL (F = 81.22 P = 0.000), distance in a 6MWT(F = 39.46 P = 0.000) and subjective perceived exertion implement the programs (Borg) (F = 9.42, P = 0.003). The significant advantage of HIAIT over other forms of CR in terms of the established changes in the assessment by Borg and MLHFQ corresponds to data in the literature.The effects of the two CR interventions upon the (QoL) were associated with improvements in functional capacity.This in turn is supported by the different impact of correlations established by the 6MWD, LVEF and changes in MLHFQ (r = 0.504, r = 0.610, p <0.001).In the HIAIT medium strength correlations with changes in other metabolic indicators such VE (r = -0.320, p <0.05) were also observed.Other indicators such as age, gender and health status, do not have such an impact on the achieved changes in (QoL) that may be associated with a lack of initial intergroup differences, as indicated in the analysis of these indicators.In studies provided in countries with highly developed and efficient functioning health care systems and a higher standard of living, reported significantly lower initial values of MLHFQ (around 22-23 points)12,13.The observed negative scores of the Qol in the Bulgarian patients with CHF can be associated, on one hand, with their socio-economic status - most of them are pensioners with low pensions, poor living standards and the deepening economic crisis. On the other hand, they can also be interpreted in relation to the problems with the health care system and its ongoing reforms, care of patients with CHF - difficulties of organizational, legal, health insurance and other nature (e.g. high rise in costs for medication, restricted access to medical specialists and lack of national CR programs).
CONCLUSION
A novel CR intervention is created for cardiologists, to integrate into the drug recompensating treatment, an effective CR training model to improve functional capacity and QoL.The data and outcomes obtained confirm the effectiveness of the application of the modified m-Ullevaal program in the clinical rehabilitation practice in Bulgaria, leading to an improvement in functional capacity and QoL.The applied CR training model m-Ullevaalis adapted in a way that is suitable for use in times of economic crisis and ongoing healthcare reform in the Bulgaria. Its first approbation, proved its high efficiency, which allows to propose its introduction into practice in wards for further treatment as a prospective, group, based on evidence, cost-efficient rehabilitation tool.
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