Preoperative exercise to improve fitness in patients undergoing complex surgery for cancer of the lung or oesophagus (PRE-HIIT): protocol for a randomized controlled trial

Abstract Objective To establish the feasibility and acceptability of a preoperative exercise program, and to obtain pilot data on the likely difference in key surgical outcomes to inform the sample size calculation for a full-scale trial. Design Pilot randomized controlled trial. Setting Royal Prince Alfred Hospital, Sydney, Australia. Subjects We included patients undergoing elective pelvic exenteration or cytoreductive surgery aged 18 to 80 years, who presented to the participating gastrointestinal surgeon at least 2 weeks prior to surgery. Patients presenting cognitive impairment, co-morbidity preventing participation in exercise, inadequate English language, currently participating in an exercise program or unable to attend the exercise program sessions were excluded. Methods Participants were randomized to a 2–6 weeks preoperative, face-to-face, individualised exercise program or to usual care. Feasibility was assessed with consent rates to the study, and for the intervention group, retention and adherence rates to the preoperative exercise program. Acceptability of the exercise program was assessed with a semi-structured questionnaire exploring the advice received and the amount, duration and intensity of the exercise program. In addition, postoperative complication rates (Clavien-Dindo), length of hospital stay and self-reported measures of health-related quality of life (SF-36v2) were collected at baseline, day before surgery and in-hospital up to discharge from hospital. Results Of 122 patients screened, 26 (21%) were eligible and 22 (85%) accepted to participate in the trial and were randomized to the intervention (11; 50%) or control group (11; 50%). The median age of the include participants was 63 years. Adherence to the preoperative exercise sessions was 92.7%, with all participants either satisfied (33%) or extremely satisfied (67%) with the overall design of the preoperative exercise program. No significant differences in outcomes were found between groups. Conclusions The results of our pilot trial demonstrate that a preoperative exercise program is feasible and acceptable to patients undergoing major abdominal cancer surgery. There is an urgent need for a definite trial investigating the effectiveness of a preoperative exercise program on postoperative outcomes in patients undergoing major abdominal cancer surgery. This could potentially reduce postoperative complication rates, length of hospital stay and subsequently overall health care costs. Trial registration ACTRN12617001129370. Registered on August 1, 2017, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373396&showOriginal=true&isReview=true

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Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

American Journal of Speech-Language Pathology ◽

10.1044/2019_ajslp-cac48-18-0227 ◽

2020 ◽

Vol 29 (1S) ◽

pp. 412-424

Author(s):

Elissa L. Conlon ◽

Emily J. Braun ◽

Edna M. Babbitt ◽

Leora R. Cherney

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Treatment Protocol ◽

Treatment Fidelity ◽

Protocol Adherence ◽

Study Condition ◽

Randomized Controlled ◽

Aphasia Therapy ◽

Percent Accuracy ◽

Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial

Journal of Speech Language and Hearing Research ◽

10.1044/2019_jslhr-l-18-0257 ◽

2019 ◽

Vol 62 (12) ◽

pp. 4464-4482 ◽

Cited By ~ 9

Author(s):

Diane L. Kendall ◽

Megan Oelke Moldestad ◽

Wesley Allen ◽

Janaki Torrence ◽

Stephen E. Nadeau

Keyword(s):

Randomized Controlled Trial ◽

Response Latency ◽

Controlled Trial ◽

Semantic Knowledge ◽

Semantic Feature ◽

Feature Analysis ◽

Group Differences ◽

Randomized Controlled ◽

Confrontation Naming ◽

Semantic Feature Analysis

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.

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