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Short-term high-intensity rehabilitation in radically treated lung cancer: a three-armed randomized controlled trial.

ABSTRACT: The feasibility and practicality of preoperative rehabilitation (PR) programs remains quite controversial in the treatment of lung cancer (LC). This study explored whether a short-term high-intensity rehabilitation program could improve postoperative outcomes compared to those achieved with conventional inspiratory muscle training (IMT).A three-armed randomized controlled trial comparing the two training modalities and routine care was conducted in surgical LC patients. Patient groups received one of three treatment regimens: (I) high-intensity pulmonary rehabilitation (PR) that combined IMT with conventional resistance training (CRT) (combined PR group); (II) conventional PR (single IMT group); or (III) routine preoperative preparation (control group). The primary endpoint was a change in the occurrence of post-operative pulmonary complications (PPCs) that occurred within 30 days after surgery, while secondary endpoints included changes in length of hospital stay, quality of life (QoL) scores, 6-min walk distance (6-MWD) and peak expiratory flow (PEF).A total of 90 enrolled patients were randomized into three groups with a computer-based 1:1:1 ratio. The intention-to-treat analysis of the study revealed that, compared with the Control Group, the Combined PR Group had a significant increase in ∆6-MWD (by 32.67 m, P=0.002), ∆PEF (by 14.3 L/min, P=0.001), ∆global scores (by 3.7, P=0.035); and a reduced ∆average total hospital stay (by 3.2 d, P=0.001) and ∆postoperative stay (by 3.6 d, P=0.001). With regard to PPC rate, the Combined PR Group had a somewhat lower PPC severity (grade II-V) compared to the Control Group.This hospital-based short-term program of PR combining high-intensity IMT with CRT was significantly superior to the conventional IMT program, indicating that this approach would be a feasible strategy for treating LC patients, especially those waiting operations with surgery-related risk factors.

SUBMITTER: Huang J

PROVIDER: S-EPMC5542945 | biostudies-other | 2017 Jul

REPOSITORIES: biostudies-other

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Project description:AIMS:To test the efficacy of a therapist-guided high-intensity internet intervention compared with an unguided low-intensity internet intervention among individuals with alcohol use disorder. DESIGN:A three-group randomized controlled trial with follow-up assessments post-treatment (12 weeks) and 6 months post-randomization (primary end-point). SETTINGS:General population sample in Sweden. PARTICIPANTS:A total of 166 on-line self-referred adults (49% males) with a score of 14 (females)/16 (males) or more on the Alcohol Use Disorders Identification Test, a preceding week alcohol consumption of 11 (females)/14 (males) or more standard drinks and an alcohol use disorder according to a diagnostic interview. INTERVENTIONS AND COMPARATORS:Both the high- (n = 72) and low-intensity internet interventions (n = 71) consisted of modules based on relapse prevention. Controls were on a waiting-list (n = 23), and were only followed until the post-treatment follow-up. Participants were randomized at a 7 : 7 : 2 ratio. MEASUREMENTS:Primary outcome was self-reported alcohol consumption in the preceding week measured as (1) number of standard drinks and (2) number of heavy drinking days at the 6-month follow-up. FINDINGS:Alcohol use disorders were largely in the severe category (74.7%), with the majority of participants having had alcohol problems for more than 5 years. Attrition was 13 and 22% at the post-treatment and 6-month follow-up, respectively. At the 6-month follow-up, an intent-to-treat analysis showed no significant differences in alcohol consumption between the high- and low-intensity interventions [standard drinks d = -0.17, 95% confidence interval (CI) = -0.50 to 0.16; heavy drinking days: d = -0.07, 95% CI = -0.40 to 0.26]. Prevalence of negative effects was somewhat low (8-14%) in both intervention groups, as was deterioration (3-5%). CONCLUSIONS:At 6-month follow-up, there were no significant differences between a therapist-guided high-intensity internet intervention and an unguided low-intensity internet intervention in reducing alcohol consumption among individuals with an alcohol use disorder.

Project description:ImportanceHigh-intensity interval training (HIIT) is recognized as a potent stimulus for improving cardiorespiratory fitness (volume of oxygen consumption [VO2] peak) in patients with coronary artery disease (CAD). However, the feasibility, safety, and long-term effects of HIIT in this population are unclear.ObjectiveTo compare HIIT with moderate-intensity continuous training (MICT) for feasibility, safety, adherence, and efficacy of improving VO2 peak in patients with CAD.Design, setting, and participantsIn this single-center randomized clinical trial, participants underwent 4 weeks of supervised training in a private hospital cardiac rehabilitation program, with subsequent home-based training and follow-up over 12 months. A total of 96 participants with angiographically proven CAD aged 18 to 80 years were enrolled, and 93 participants were medically cleared for participation following a cardiopulmonary exercise test. Data were collected from May 2016 to December 2018, and data were analyzed from December 2018 to August 2019.InterventionsA 4 × 4-minute HIIT program or a 40-minute MICT program (usual care). Patients completed 3 sessions per week (2 supervised and 1 home-based session) for 4 weeks and 3 home-based sessions per week thereafter for 48 weeks.Main outcomes and measuresThe primary outcome was change in VO2 peak during the cardiopulmonary exercise test from baseline to 4 weeks. Further testing occurred at 3, 6, and 12 months. Secondary outcomes were feasibility, safety, adherence, cardiovascular risk factors, and quality of life.ResultsOf 93 randomized participants, 78 (84%) were male, the mean (SD) age was 65 (8) years, and 46 were randomized to HIIT and 47 to MICT. A total of 86 participants completed testing at 4 weeks for the primary outcome, including 43 in the HIIT group and 43 in the MICT group; 69 completed testing at 12 months for VO2 peak, including 32 in the HIIT group and 37 in the MICT group. After 4 weeks, HIIT improved VO2 peak by 10% compared with 4% in the MICT group (mean [SD] oxygen uptake: HIIT, 2.9 [3.4] mL/kg/min; MICT, 1.2 [3.4] mL/kg/min; P = .02). After 12 months, there were similar improvements from baseline between groups, with a 10% improvement in the HIIT group and a 7% improvement in the MICT group (mean [SD] oxygen uptake: HIIT, 2.9 [4.5] mL/kg/min; MICT, 1.8 [4.3] mL/kg/min; P = .30). Both groups had high feasibility scores and low rates of withdrawal due to serious adverse events (3 participants in the HIIT group and 1 participant in the MICT group). One event occurred following exercise (hypotension) in the HIIT group. Over 12 months, both home-based HIIT and MICT had low rates of adherence (HIIT, 18 of 34 [53%]; MICT, 15 of 37 [41%]; P = .35) compared with the supervised stage (HIIT, 39 of 44 [91%]; MICT, 39 of 43 [91%]; P > .99).Conclusions and relevanceIn this randomized clinical trial, a 4-week HIIT program improved VO2 peak compared with MICT in patients with CAD attending cardiac rehabilitation. However, improvements in VO2 peak at 12 months were similar for both groups. HIIT was feasible and safe, with similar adherence to MICT over 12-month follow-up. These findings support inclusion of HIIT in cardiac rehabilitation programs as an adjunct or alternative modality to moderate-intensity exercise.Trial registrationAustralian New Zealand Clinical Trials Registry Identifier: ACTRN12615001292561.

Project description:We aimed to investigate the effectiveness of two different forms of dry pulsatile cupping in patients with chronic low back pain (cLBP) compared to medication on demand only in a three-armed randomized trial.110 cLBP patients were randomized to regular pulsatile cupping with 8 treatments plus paracetamol on demand (n =?37), minimal cupping with 8 treatments plus paracetamol on demand (n =?36) or the control group with paracetamol on demand only (n?=?37). Primary outcome was the pain intensity on a visual analogue scale (VAS, 0-100 mm) after 4 weeks, secondary outcome parameter included VAS pain intensity after 12 weeks, back function as measured with the 'Funktionsfragebogen Hannover Rücken' (FFbH-R) and health related quality of life questionnaire Short form 36 (SF-36) after 4 and 12 weeks.The mean baseline-adjusted VAS after 4 weeks was 34.9 mm (95% CI: 28.7; 41.2) for pulsatile cupping, 40.4 (34.2; 46.7) for minimal cupping and 56.1 (49.8; 62.4) for control group, resulting in statistically significant differences between pulsatile cupping vs. control (21.2 (12.2; 30.1); p <?0.001) and minimal cupping vs. control (15.7 (6.9; 24.4); p =?0.001). After 12 weeks, mean adjusted VAS difference between pulsatile cupping vs. control was 15.1 ((3.1; 27.1); p =?0.014), and between minimal cupping vs. control 11.5 ((-?0.44; 23.4); p =?0.059). Differences of VAS between pulsatile cupping and minimal cupping showed no significant differences after 4 or 12 weeks. Pulsatile cupping was also better (-?5.8 (-?11.5;-0.1); p =?0.045) compared to control for back function after 4 weeks, but not after 12 weeks (-?5.4 (-?11.7;0.8); p =?0.088), pulsatile cupping also showed better improvements on SF-36 physical component scale compared to control at 4 and 12 weeks (-?5.6 (-?9.3;-2.0); p =?0.003; -?6.1 (-?9.9;-2.4); p =?0.002). For back function and quality of life minimal cupping group was not statistically different to control after 4 and 12 weeks. Paracetamol intake did not differ between the groups (cupping vs. control (7.3 (-?0.4;15.0); p =?0.063); minimal cupping vs. control (6.3 (-?2.0;14.5); p =?0.133).Both forms of cupping were effective in cLBP without showing significant differences in direct comparison after four weeks, only pulsatile cupping showed effects compared to control after 12 weeks.The study was registered at ClinicalTrials.gov (identifier: NCT02090686 ).

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Short-term high-intensity rehabilitation in radically treated lung cancer: a three-armed randomized controlled trial.

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