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The impact of additional resistance and balance training in exercise-based cardiac rehabilitation in older patients after valve surgery or intervention: randomized control trial |
Tamuleviciute-Prasciene E, Beigiene A, Thompson MJ, Balne K, Kubilius R, Bjarnason-Wehrens B |
BMC Geriatrics 2021 Jan 7;21(23):Epub |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: To evaluate the short- and mid-term effect of a specially tailored resistance and balance training provided in addition to usual cardiac rehabilitation (CR) care program in older patients after valve surgery/intervention. METHODS: Single-center (inpatient CR clinic in Lithuania) randomized controlled trial. Two hundred fifty-two patients were assessed for eligibility on the first day of admittance to CR early after (14.5 +/- 5.9 days) valve surgery/intervention between January 2018 and November 2019. Participants were coded centrally in accordance with randomization 1:1 using a computerized list. Control group (CG) patients were provided with usual care phase-II-CR inpatient multidisciplinary CR program, while intervention group (IG) patients received additional resistance and balance training (3 d/wk). Patients participated in a 3-month follow-up. Main outcome measures were functional capacity (6 min walk test (6MWT, meters), cardiopulmonary exercise testing), physical performance (Short Physical Performance Battery (SPPB, score) and 5-m walk test (5MWT, meters/second)), strength (one repetition maximum test for leg press), physical frailty (SPPB, 5MWT). RESULTS: One hundred sixteen patients (76.1 +/- 6.7 years, 50% male) who fulfilled the study inclusion criteria were randomized to IG (n = 60) or CG (n = 56) and participated in CR (18.6 +/- 2.7 days). As a result, 6MWT (IG 247 +/- 94.1 versus 348 +/- 100.1, CG 232 +/- 102.8 versus 333 +/- 120.7), SPPB (IG 8.31 +/- 2.21 versus 9.51 +/- 2.24, CG 7.95 +/- 2.01 versus 9.08 +/- 2.35), 5MWT (IG 0.847 +/- 0.31 versus 0.965 +/- 0.3, CG 0.765 +/- 0.24 versus 0.879 +/- 0.29) all other outcome variables and physical frailty level improved significantly (p < 0.05) in both groups with no significant difference between groups. Improvements were sustained over the 3-month follow-up for 6MWT (IG 348 +/- 113 versus CG 332 +/- 147.4), SPPB (IG 10.37 +/- 1.59 versus CG 9.44 +/- 2.34), 5MWT (IG 1.086 +/- 0. 307 versus CG 1.123 +/- 0.539) and other variables. Improvement in physical frailty level was significantly more pronounced in IG (p < 0.05) after the 3-month follow-up. CONCLUSION: Exercise-based CR improves functional and exercise capacity, physical performance, and muscular strength, and reduces physical frailty levels in patients after valve surgery/intervention in the short and medium terms. SPPB score and 5MWT were useful for physical frailty assessment, screening and evaluation of outcomes in a CR setting. Additional benefit from the resistance and balance training could not be confirmed. TRIAL REGISTRATION: NCT04234087, retrospectively registered 21 January 2020.
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