Rest or 30-Min Walk as Exercise Intervention (RESTOREX) in Myasthenia Gravis: A Randomized Controlled Trial

Introduction: There is a lack of evidence about the usefulness of exercise or rest in myasthenia gravis (MG). This study is aimed to evaluate the efficacy and safety of exercise or rest in MG. Methods: In a single-center open-labeled randomized controlled trial, the patients with mild to moderate MG were randomized to 30-min walk or rest in addition to the standard treatment. The primary endpoint was 50% improvement in the MG Quality of Life (MG-QOL15), and secondary endpoints were change in the Myasthenic Muscle Score (MMS), MG Activities of Daily Living (MGADL), grip strength, dose of acetylcholine esterase inhibitor and prednisone, 6-min walk test (6MWT), decrement in trapezius on the low-rate repetitive nerve stimulation test, and adverse events. The outcomes were defined at 3 months, by >50% improvement in these outcome parameters. Results: Forty patients with MG were randomized to the exercise or rest arm. The 2 arms were matched for demographic and clinical parameters. The patients in the exercise arm had significantly better QOL evidenced by MG-QOL15 (p = 0.02). The secondary endpoints, distance covered in 6MWT (p = 0.007), were also better in the exercise arm without any adverse event. Conclusion: Regular exercise for 30 min in mild and moderate MG improves quality of life and walking distance compared to rest and is safe. Clinical Trial Registration: The clinical trial registration number is CTRI/2019/11/021869.

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The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors

JMIR Research Protocols ◽

10.2196/31976 ◽

2021 ◽

Vol 10 (9) ◽

pp. e31976

Author(s):

Nicholas J Hulbert-Williams ◽

Monica Leslie ◽

Lee Hulbert-Williams ◽

Bogda Koczwara ◽

Eila K Watson ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Randomized Controlled Trial ◽

Cancer Survivors ◽

Controlled Trial ◽

Research Network ◽

Web Based ◽

Randomized Controlled ◽

The Impact

Background Cancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished and are predictive of psychological distress and poor health-related quality of life. Web-based interventions demonstrate good efficacy in addressing these concerns and are more accessible than face-to-face interventions. Finding My Way (FMW) is a web-based, psycho-educational, and cognitive behavioral therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated that FMW is acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life while leading to cost savings through health resource use reduction. Objective This study aims to adapt the Australian FMW website for a UK cancer care context and then undertake a single-blinded, randomized controlled trial of FMW UK against a treatment-as-usual waitlist control. Methods To an extent, our trial design replicates the existing Australian randomized controlled trial of FMW. Following a comprehensive adaptation of the web resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will have been diagnosed with cancer of any type in the last 6 months, have received anticancer treatment with curative intent, be aged ≥16 years, be proficient in English, and have access to the internet and an active email address. Participants will be identified and recruited through the National Institute for Health Research clinical research network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report web-based questionnaire at baseline, midtreatment, posttreatment, and both 3- and 6-month follow-up. Quantitative data will be analyzed using intention-to-treat mixed model repeated measures analysis. Embedded semistructured qualitative interviews will probe engagement with, and experiences of using, FMW UK and suggestions for future improvements. Results The website adaptation work was completed in January 2021. A panel of cancer survivors and health care professionals provided feedback on the test version of FMW UK. Feedback was positive overall, although minor updates were made to website navigation, inclusivity, terminology, and the wording of the Improving Communication and Sexuality and Intimacy content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid-2023. Conclusions Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literature, especially in different geographical settings. Before replicating the FMW trial in the UK setting, content updating was required. If FMW UK now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for cancer survivors in the United Kingdom. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 14317248; https://www.isrctn.com/ISRCTN14317248 International Registered Report Identifier (IRRID) DERR1-10.2196/31976

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Physical Activity as a Predictor of Clinical Trial Outcomes in Bipolar Depression: A Subanalysis of a Mitochondrial-Enhancing Nutraceutical Randomized Controlled Trial

The Canadian Journal of Psychiatry ◽

10.1177/0706743719889547 ◽

2019 ◽

Vol 65 (5) ◽

pp. 306-318 ◽

Cited By ~ 1

Author(s):

Melanie M. Ashton ◽

Mohammadreza Mohebbi ◽

Alyna Turner ◽

Wolfgang Marx ◽

Michael Berk ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Clinical Trial ◽

Randomized Controlled Trial ◽

Rating Scale ◽

Bipolar Depression ◽

Controlled Trial ◽

Randomized Controlled ◽

The Relationship

Objectives Individuals with bipolar disorder (BD) generally engage in low levels of physical activity (PA), and yet few studies have investigated the relationship between PA and change in BD symptom severity. The aim of this subanalysis of an adjunctive nutraceutical randomized controlled trial for the treatment of bipolar depression was to explore the relationship between PA, the active adjunctive treatments (a nutraceutical “mitochondrial cocktail”), and clinical outcomes. Methods Participants with bipolar depression were randomized to receive N-acetylcysteine alone, N-acetylcysteine with a combination of nutraceuticals (chosen for the potential to increase mitochondrial activity), or placebo for 16 weeks. Participants ( n = 145) who completed the International Physical Activity Questionnaire–Short Form (IPAQ-SF; measured at Week 4) were included in this exploratory subanalysis. Assessments of BD symptoms, functioning, and quality of life were completed at monthly visits up until Week 20. Generalised Estimating Equations were used to explore whether IPAQ-SF scores were a moderator of treatment received on outcomes of the study. Results Week-4 PA was not related to changes in Montgomery Åsberg Depression Rating Scale scores across the study until Week 20. However, participants who engaged in more PA and who received the combination treatment were more likely to have a reduction in scores on the Bipolar Depression Rating Scale ( P = 0.03). However, this was not consistent in all domains explored using the IPAQ-SF. Participants who engaged in higher levels of PA also experienced greater improvement in social and occupational functioning and less impairment in functioning due to their psychopathology and improvement in quality of life at Week 20, irrespective of treatment. Conclusions This study provides novel evidence of the association between PA and reduction in BD symptoms in a nutraceutical clinical trial. However, further research assessing the potential synergistic effects of PA in BD is required.

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The Finding My Way UK Clinical Trial: Adaptation Report and Protocol for a Replication Randomized Controlled Efficacy Trial of a Web-Based Psychological Program to Support Cancer Survivors (Preprint)

10.2196/preprints.31976 ◽

2021 ◽

Author(s):

Nicholas J Hulbert-Williams ◽

Monica Leslie ◽

Lee Hulbert-Williams ◽

Bogda Koczwara ◽

Eila K Watson ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Randomized Controlled Trial ◽

Cancer Survivors ◽

Controlled Trial ◽

Research Network ◽

Web Based ◽

Randomized Controlled ◽

The Impact

BACKGROUND Cancer survivors frequently report a range of unmet psychological and supportive care needs; these often continue after treatment has finished and are predictive of psychological distress and poor health-related quality of life. Web-based interventions demonstrate good efficacy in addressing these concerns and are more accessible than face-to-face interventions. Finding My Way (FMW) is a web-based, psycho-educational, and cognitive behavioral therapy intervention for cancer survivors developed in Australia. Previous trials have demonstrated that FMW is acceptable, highly adhered to, and effective in reducing the impact of distress on quality of life while leading to cost savings through health resource use reduction. OBJECTIVE This study aims to adapt the Australian FMW website for a UK cancer care context and then undertake a single-blinded, randomized controlled trial of FMW UK against a treatment-as-usual waitlist control. METHODS To an extent, our trial design replicates the existing Australian randomized controlled trial of FMW. Following a comprehensive adaptation of the web resource, we will recruit 294 participants (147 per study arm) from across clinical sites in North West England and North Wales. Participants will have been diagnosed with cancer of any type in the last 6 months, have received anticancer treatment with curative intent, be aged ≥16 years, be proficient in English, and have access to the internet and an active email address. Participants will be identified and recruited through the National Institute for Health Research clinical research network. Measures of distress, quality of life, and health economic outcomes will be collected using a self-report web-based questionnaire at baseline, midtreatment, posttreatment, and both 3- and 6-month follow-up. Quantitative data will be analyzed using intention-to-treat mixed model repeated measures analysis. Embedded semistructured qualitative interviews will probe engagement with, and experiences of using, FMW UK and suggestions for future improvements. RESULTS The website adaptation work was completed in January 2021. A panel of cancer survivors and health care professionals provided feedback on the test version of FMW UK. Feedback was positive overall, although minor updates were made to website navigation, inclusivity, terminology, and the wording of the Improving Communication and Sexuality and Intimacy content. Recruitment for the clinical trial commenced in April 2021. We aim to report on findings from mid-2023. CONCLUSIONS Replication studies are an important aspect of the scientific process, particularly in psychological and clinical trial literature, especially in different geographical settings. Before replicating the FMW trial in the UK setting, content updating was required. If FMW UK now replicates Australian findings, we will have identified a novel and cost-effective method of psychosocial care delivery for cancer survivors in the United Kingdom. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 14317248; https://www.isrctn.com/ISRCTN14317248 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/31976

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Effects of the tailored activity program (TAP) on dementia-related symptoms, health events and caregiver wellbeing: a randomized controlled trial

BMC Geriatrics ◽

10.1186/s12877-021-02511-4 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Laura N. Gitlin ◽

Katherine Marx ◽

Catherine Verrier Piersol ◽

Nancy A. Hodgson ◽

Jin Huang ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Clinical Symptoms ◽

Controlled Trial ◽

Attention Control ◽

Trial Registration ◽

Clinical Trial Registration ◽

Randomized Controlled ◽

Activity Program ◽

Health Related

Abstract Background People living with dementia (PLWD) and caregivers are adversely impacted by lack of meaningful activity leading to worse symptoms and impaired quality-of-life. There is a critical need to develop effective and well-tolerated treatments that mitigate clinical symptoms, engage PLWD and support caregiver wellbeing. We tested whether, compared to attention control, the Tailored Activity Program (TAP) reduced clinical symptoms and health-related events, and improved caregiver wellbeing, and if TAP activities were well-tolerated. Methods We conducted a single-blind randomized controlled trial among 250 dyads recruited from Baltimore-Washington DC (2012–2016) with a dementia diagnosis and clinically significant agitation/aggression. Dyads were randomized to TAP (n = 124) or attention control (n = 126), and interviewed at baseline, 3 (endpoint) and 6-months (follow-up) by interviewers masked to group allocation. TAP assessed PLWD abilities/interests, instructed caregivers in using prescribed activities, and provided dementia education and stress reduction techniques. Attention controls received disease education and home safety tips. Both groups had up to 8 home visits over 3-months. The primary outcome was frequency by severity scores for agitation/aggression subscales of Neuropsychiatric Inventory-Clinician using caregiver ratings. Secondary outcomes included number of instrumental (IADL) and activities of daily living (ADL) needing assistance, caregiver wellbeing, and confidence using activities. Health-related events (PLWD death, hospitalizations, caregiver hospitalization, depression) and perceived study benefits were captured over 6 months. PLWD tolerability of prescribed activities was examined. Results Of 250 dyads, most caregivers were female (81.2 %, n = 203), non-spouses (54.4 %, n = 136), white (59.2 %, n = 145) or African American (36.7 %, n = 90) with mean age = 65.4 (SD = 12.6). PLWD were mostly female (63.2 %, n = 158) with mean age = 81.4 (SD = 7.9), and mean MMSE = 14.3 (SD = 7.8). At 3-months, compared to controls, TAP conferred no benefit to agitation/aggression (p = 0.43, d = 0.11), but resulted in less IADL (p = 0.02, d=-0.33), and ADL (p = 0.04, d=-0.30) assistance, improved caregiver wellbeing (p = 0.01, d = 0.39), and confidence using activities (p = 0.02, d = 0.32). By 6-months, 15 PLWD in TAP had ≥ 1 health-related event versus 28 PLWD in control, demonstrating 48.8 % improvement in TAP (p = 0.03). TAP caregivers were more likely to perceive study benefits. Prescribed activities were well-tolerated. Conclusions Although TAP did not benefit agitation/aggression, it impacted important outcomes that matter to families warranting its use in dementia care. Clinical trial registration Clinicaltrials.gov # NCT01892579 at https://clinicaltrials.gov/; Date of clinical trial registration: 04/07/2013; Date first dyad enrolled: 15/11/2013.

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