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A resilience group training program for people with multiple sclerosis: Results of a pilot single-blind randomized controlled trial and nested qualitative study.

ABSTRACT: INTRODUCTION:An Australian case series study demonstrated the effectiveness of the REsilience and Activities for every DaY for people with multiple sclerosis (READY for MS), a resilience group training program based on Acceptance and Commitment Therapy, in improving quality of life in people with MS. This study aimed to evaluate the feasibility and acceptability of the Italian READY for MS program, and to preliminary assess its efficacy when compared to an active control intervention (group relaxation). METHODS:Single-blind phase II randomized controlled trial (RCT) and nested qualitative study (ISRCTN registration number: 38971970). Health-related quality of life (primary study outcome), mood, resilience, psychological flexibility and its protective factors were measured at baseline, after seven, 12 and 24 weeks. READY participants completed the purpose-built satisfaction questionnaire after 12 weeks. After trial completion, the control group also received READY. One-to-one participant interviews were conducted within three months of finishing the READY groups. RESULTS:Four intervention groups were conducted with 39 participants (20 READY, 19 relaxation). Two patients (READY) withdrew before beginning the intervention due to unexpected work commitments. Feasibility and acceptability of READY were good, with high participant engagement and satisfaction. No statistical effects of READY were detected vs relaxation. Thirty participants were interviewed (18 READY; 12 relaxation + READY). Content data analysis revealed seven overarching themes: "Attitudes towards participation"; "Perceptions of program composition"; "Program impacts on life domains"; "Program active elements"; "Program improvement trajectories"; "Program differences and similarities"; "Suggested READY improvements". CONCLUSION:READY was well accepted by MS patients with varied socio-demographic and clinical characteristics. Qualitative (but not quantitative) data provided evidence in favour of READY. Our findings will inform methodological and intervention refinements for the multi-centre RCT that will follow.

SUBMITTER: Giovannetti AM

PROVIDER: S-EPMC7145197 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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A resilience group training program for people with multiple sclerosis: Results of a pilot single-blind randomized controlled trial and nested qualitative study.

Giovannetti Ambra Mara AM Quintas Rui R Tramacere Irene I Giordano Andrea A Confalonieri Paolo P Messmer Uccelli Michele M Solari Alessandra A Pakenham Kenneth Ian KI

PloS one 20200409 4

<h4>Introduction</h4>An Australian case series study demonstrated the effectiveness of the REsilience and Activities for every DaY for people with multiple sclerosis (READY for MS), a resilience group training program based on Acceptance and Commitment Therapy, in improving quality of life in people with MS. This study aimed to evaluate the feasibility and acceptability of the Italian READY for MS program, and to preliminary assess its efficacy when compared to an active control intervention (gr ...[more]

PMID: 32271833

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Project description:Background: An 8-week educational intervention co-taught by medical students and faculty was designed to foster communication between clinical researchers and populations of interest to ultimately increase participation in clinical research by older adults, including underrepresented groups. Weekly topics focused on age-related changes and health conditions, socio-contextual factors impacting aging populations, and wellness strategies. Objectives: To evaluate the successes and weaknesses of an educational intervention aimed at increasing the participation of older adults in clinical research. Design: A focus group was assembled after an 8-week educational intervention, titled DREAMS, to obtain participants' feedback on the program, following a pre-formulated interview guide. Settings: Participants were interviewed in a health center office environment in the United States of America in April of 2016. Participants: A post-intervention focus group was conducted with a group of eight older adults (mean age = 75.8 ± 11.4 years) from 51 total participants who completed the intervention. Methods: The focus group was interviewed loosely following a pre-formed question guide. Participants were encouraged to give honest feedback. The conversation was recorded, transcribed verbatim, and analyzed using thematic analyses. Results: While participants viewed most aspects of the study as a success and stated that it was a productive learning experience, most participants had suggestions for improvements in the program content and implementation. Specifically, the composition of and direction to small breakout groups should be carefully considered and planned in this population, and attention should be paid to the delivery of sensitive topic such as death and dementia. A clear main benefit of this programmatic approach is the development of a rapport amongst participants and between participants and clinical researchers. Conclusions: The results provide useful insights regarding improving participation among hard-to-reach and historically underrepresented groups of older adults in clinical research. Future iterations of this program and similar educational interventions can use these findings to better achieve the programmatic objectives.

Project description:Maintaining the ability to walk is one of the significant challenges in people with multiple sclerosis (MS) for keeping a good quality of life as the disease and the aging process progresses. Overground robotic (OR) wearable exoskeletons are promising tools for gait rehabilitation, but currently there is no evidence of their clinical effects on patients with MS. The present study aims to determine the effects of an OR intervention in people with MS and moderate to severe walking disabilities and ascertain if benefits are maintained over a follow-up period of 3 months. This randomized controlled trial will include 36 participants with MS. Inclusion criteria are: older than 18 years, definitive diagnosis of MS, 4.5-7 points on the EDSS (Expanded Disability Status Scale), and needing one or two canes or crutches for walking outdoors. Subjects in the control group will receive conventional physiotherapy sessions at ADEMBI (Asociación de Esclerosis Múltiple de Bizkaia) provided to control spasticity, maintain articular range and exercise balance. Subjects in the intervention group will receive the same physiotherapy but also participate in a progressive OR gait training program assisted by the EksoTM exoskeleton. The program consists of twice a week individually supervised sessions in two setting modalities: PreGait and ProStepPlus. The training parameters (duration, speed, cadence, length of steps) will be set during the first session and the progression and intensity of the intervention will be adapted to the tolerance of each participant. The primary outcome of this study is gait speed. Secondary outcomes will include physical and cognitive performance tests, clinical, fatigue and quality of life assessments, and changes in the plasma levels of inflammatory cytokines. The present trial is the first analyzing the effectiveness of an OR intervention for gait training in patients with MS. It will help clarify the applicability of robotic technologies to clinical practice, extending the functionality and quality of life of people with MS to face a successful aging process. (ACTRN12619000014156; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376548).

Project description:Objective To investigate whether inspiratory muscle training (IMT) offered adjunctively to an exercise training program reduces symptoms of dyspnea in survivors of breast cancer. Design Double-blind, parallel-group, randomized controlled trial. Setting Outpatient rehabilitation program in a university hospital. Participants Ninety-eight female patients with breast cancer who completed adjuvant treatment and subsequently entered cancer rehabilitation were screened for participation. Inclusion criteria were reduced inspiratory muscle strength and/or symptoms of dyspnea. Twenty patients (N=20) were randomly assigned to an intervention group (n=10) or a control group (n=10). Intervention Both groups received a 3-month exercise training program in combination with either IMT (intervention) or sham-IMT (control). Main Outcome Measures Changes in dyspnea intensity perception (10-point Borg Scale) at comparable time points (isotime) during constant work rate cycling was the primary outcome. Secondary outcomes included changes in respiratory muscle function, exercise capacity, and changes in symptoms of dyspnea during daily life (Transitional Dyspnea Index [TDI]). Results The intervention group achieved a larger reduction in exertional dyspnea at isotime compared with the control group (−1.8 points; 95% CI, −3.7 to 0.13; P=.066). The intervention group also exhibited larger improvements in dyspnea during daily life (TDI score, +2.9 points; 95% CI, 0.5-5.3; P=.022) and improved both respiratory muscle endurance (+472 seconds; 95% CI, 217-728; P=.001) and cycling endurance (+428 seconds; 95% CI, 223-633; P=.001) more than the control group. Conclusions Because of the limited sample size all obtained findings need to be interpreted with caution. The study offers initial insights into the potential of adjunctive IMT in selected survivors of breast cancer. Larger multicenter studies should be performed to further explore the potential role and general acceptance of this intervention as a rehabilitation tool in selected patients after breast cancer treatment.

Dataset Information

A resilience group training program for people with multiple sclerosis: Results of a pilot single-blind randomized controlled trial and nested qualitative study.

Publications

A resilience group training program for people with multiple sclerosis: Results of a pilot single-blind randomized controlled trial and nested qualitative study.

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