scholarly journals Muscle stimulation in advanced idiopathic pulmonary fibrosis: a randomised placebo-controlled feasibility study

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048808
Author(s):  
Claire M Nolan ◽  
Suhani Patel ◽  
Ruth E Barker ◽  
Jessica A Walsh ◽  
Oliver Polgar ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Adverse Events ◽  
Outcome Measures ◽  
Care Home ◽  
Intervention Group ◽  
Feasibility Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Definitive Trial

ObjectivesTo assess the acceptability of neuromuscular electrical stimulation (NMES) of the quadriceps muscles in people with idiopathic pulmonary fibrosis (IPF) and to identify whether a future definitive trial is feasible.DesignA randomised, parallel, two-group, participant and assessor-blinded, placebo-controlled feasibility trial with embedded qualitative interviews.SettingOutpatient department, Royal Brompton and Harefield Hospitals.ParticipantsTwenty-two people with IPF: median (25th, 75th centiles) age 76 (74, 82) years, forced vital capacity 62 (50, 75) % predicted, 6 min walk test distance 289 (149, 360) m.InterventionsUsual care (home-based exercise, weekly telephone support, breathlessness management leaflet) with either placebo or active NMES for 6 weeks, with follow-up at 6 and 12 weeks.Primary outcome measuresFeasibility of recruitment and retention, treatment uptake and adherence, outcome assessments, participant and outcome assessor blinding and adverse events related to interventions.Secondary outcome measuresOutcome measures with potential to be primary or secondary outcomes in a definitive clinical trial. In addition, purposively sampled participants were interviewed to capture their experiences and acceptability of the trial.ResultsOut of 364 people screened, 23 were recruited: 11 were allocated to each group and one was withdrawn prior to randomisation. Compared with the control group, a greater proportion of the intervention group completed the intervention, remained in the trial blinded to group allocation and experienced intervention-related adverse events. Assessor blinding was maintained. The secondary outcome measures were feasible with most missing data associated with the accelerometer. Small participant numbers precluded identification of an outcome measure suitable for a definitive trial. Qualitative findings demonstrated that trial process and active NMES were acceptable but there were concerns about the credibility of placebo NMES.ConclusionsPrimarily owing to recruitment difficulties, a definitive trial using the current protocol to evaluate NMES in people with IPF is not feasible.Trial registration numberNCT03499275.

scholarly journals A Randomised Controlled Trial Evaluating the Effectiveness and Tolerability of Step-up and Step-down Varenicline Therapy for Smoking Cessation: A Study Protocol

2017 ◽  
Vol 13 (3) ◽  
pp. 179-185
Author(s):  
Aaron D. Drovandi ◽  
Peta-Ann Teague ◽  
Beverley D. Glass ◽  
Bunmi Malau-Aduli
Keyword(s):  
Smoking Cessation ◽  
Adverse Events ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Intervention Group ◽  
Withdrawal Symptoms ◽  
Secondary Outcome ◽  
Control Group ◽  
Step Down

Background: Varenicline remains the most effective medication for smoking cessation; however, discontinuation as a result of adverse events negatively impacts medication adherence, and the likelihood of a quit attempt being successful. Post-treatment cravings and withdrawal symptoms may also occur, increasing the likelihood of treatment failure, due to lapse and relapse after achieving initial abstinence. This protocol details a trial investigating changes in the effectiveness and tolerability of varenicline, when an extended step-up and step-down regimen are used.Methods: A phase four, randomised, double-blinded, placebo-controlled single-centre study with a treatment period of 16 weeks, and follow-up period of 12 weeks will be conducted. Up to 201 participants will be enrolled and allocated in a 1:1:1 ratio to a placebo-matching control group, step-up, or step-down intervention group, all receiving behavioural counselling and quitting advice. Participants will be contacted weekly during treatment and fortnightly during follow-up. Eligible participants are smokers over 18 years old, willing to quit smoking, are able to attend clinic visits, and have no uncontrolled or serious medical issues. Primary outcome measures are comparisons of biochemically confirmed continuous abstinence rates, 7-day point prevalence abstinence rates, and the frequency, severity and duration of adverse events, cravings and withdrawal symptoms. Secondary outcome measures are participant adherence to the study medication throughout treatment, and comparisons of changes in smoking satisfaction and reward. Effects of each regimen on smoking cessation will be assessed by logistic regression, with survival analyses used for a more precise estimate of when cessation occurs. Primary endpoints will then be compared using a general linear model. Australian New Zealand Clinical Trials Registry: ACTRN12616000802404p

scholarly journals Randomised controlled feasibility trial of an active communication education programme plus hearing aid provision versus hearing aid provision alone (ACE To HEAR)

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e043364
Author(s):  
Judith Watson ◽  
Elizabeth Coleman ◽  
Cath Jackson ◽  
Kerry Bell ◽  
Christina Maynard ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Hearing Aids ◽  
Hearing Aid ◽  
Intervention Group ◽  
Feasibility Trial ◽  
Control Group ◽  
Communication Education ◽  
Treatment As Usual ◽  
Active Communication ◽  
Randomised Controlled

ObjectiveTo establish the acceptability and feasibility of delivering the Active Communication Education (ACE) programme to increase quality of life through improving communication and hearing aid use in the UK National Health Service.DesignRandomised controlled, open feasibility trial with embedded economic and process evaluations.SettingAudiology departments in two hospitals in two UK cities.ParticipantsTwelve hearing aid users aged 18 years or over who reported moderate or less than moderate benefit from their new hearing aid.InterventionsConsenting participants (along with a significant other) were to be randomised by a remote, centralised randomisation service in groups to ACE plus treatment-as-usual (intervention group) or treatment-as-usual only (control group).Primary outcome measuresThe primary outcomes were related to feasibility: recruitment, retention, treatment adherence and acceptability to participants and fidelity of treatment delivery.Secondary outcome measuresInternational Outcomes Inventory for Hearing Aids, Self-Assessment of Communication, EQ-5D-5L and Short-Form 36. Blinding of the participants and facilitator was not possible.ResultsTwelve hearing aid users and six significant others consented to take part. Eight hearing aid users were randomised: four to the intervention group; and four to treatment-as-usual only. Four significant others participated alongside the randomised participants. Recruitment to the study was very low and centres only screened 466 hearing aid users over the 15-month recruitment period, compared with the approximately 3500 anticipated. Only one ACE group and one control group were formed. ACE could be delivered and appeared acceptable to participants. We were unable to robustly assess attrition and attendance rates due to the low sample size.ConclusionsWhile ACE appeared acceptable to hearing aid users and feasible to deliver, it was not feasible to identify and recruit participants struggling with their hearing aids at the 3-month posthearing aid fitting point.Trial registration numberISRCTN28090877.

scholarly journals Safety and effectiveness of a Tai Chi-based cardiac rehabilitation programme for chronic coronary syndrom patients: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036061
Author(s):  
Jing Ma ◽  
Jian wei Zhang ◽  
Hua Li ◽  
Lian shan Zhao ◽  
Ai ying Guo ◽  
...  
Keyword(s):  
Cardiac Rehabilitation ◽  
Outcome Measures ◽  
Tai Chi ◽  
Short Form ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Cardiac Rehabilitation Programme ◽  
Tai Chi Exercise ◽  
Randomised Controlled

IntroductionPreliminary evidence from clinical observations suggests that Tai Chi exercise may offer potential benefits for patients with chronic coronary syndrom (CCS). However, the advantages for CCS patients to practice Tai Chi exercise as rehabilitation have not been rigorously tested and there is a lack of consensus on its benefits. This study aims to develop an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for CCS patients and to assess the efficacy, safety and acceptability of the programme.Methods and analysisWe propose to conduct a multicentre randomised controlled clinical trial comprising of 150 participants with CCS. The patients will be randomly assigned in a 1:1 ratio into two groups. The intervention group will participate in a supervised TCCRP held three times a week for 3 months. The control group will receive supervised conventional exercise rehabilitation held three times a week for 3 months. The primary and secondary outcomes will be assessed at baseline, 1 month, 3 months after intervention and after an additional 3-month follow-up period. Primary outcome measures will include a score of 36-Item Short Form Survey and Chinese Perceived Stress Scale. The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination. Other measures also include Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale. All adverse events will be recorded and analysed.Ethics and disseminationThis study conforms to the principles of the Declaration of Helsinki and relevant ethical guidelines. Ethical approval has been obtained from the Ethics Committee of Chinese People’s Libration Army General Hospital (approval number: S2019-060-02). Findings from this study will be published and presented at conferences for widespread dissemination of the results.Trial registration numberNCT03936504.

scholarly journals Randomised, prospective clinical trial of platelet-rich plasma injection in the management of severe dry eye

2018 ◽  
Vol 103 (5) ◽  
pp. 648-653 ◽  
Author(s):  
Marcel Y Avila ◽  
Angela M Igua ◽  
Amparo M Mora
Keyword(s):  
Hyaluronic Acid ◽  
Outcome Measures ◽  
Dry Eye ◽  
Primary Outcome ◽  
Platelet Rich Plasma ◽  
Intervention Group ◽  
Treatment Compliance ◽  
Secondary Outcome ◽  
Control Group ◽  
Corneal Staining

BackgroundTo evaluate the effectiveness of platelet-rich plasma (PRP) injections in the treatment of severe dry eye.MethodsThis prospective, intervention study included patients with severe dry eye who had been diagnosed with Sjogren syndrome. Patients were divided into two groups. The intervention group received PRP (n=15) injections on days 0, 30, 60 and 90, as well as hyaluronic acid five times per day. The comparison group received hyaluronic acid (n=15) five times per day. Subjects were measured at baseline and at 30, 60 and 90 days. The primary outcome measures were changes in corneal staining according to the Oxford classification, results of the Schirmer test and tear break-up time (TBUT). The secondary outcome measures were changes in the Ocular Surface Disease Index (OSDI) and treatment compliance.ResultsAll subjects completed the study. The intervention group showed improvements in all primary outcome measures when compared with the control group, including a reduction in corneal staining (p<0.001), increase in the mean Schirmer value from 5.6±0.7 to 9.0±1.1 mm, and an increase in TBUT from 4.0±0.4 to 6.4±0.4 s at day 90. An improvement in subjective OSDI values was also found.ConclusionPRP injection is safe and effective in improving tear parameters as well as subjective parameters, and was found to be superior to hyaluronic acid alone in the management of patients with severe dry eye. This represent a novel alternative treatment for severe dry eye.Trial registration numberNCT02257957.

scholarly journals Virtual Environment Rehabilitation for Patients with Motor Neglect Trial (VERMONT): A Single-Center Randomized Controlled Feasibility Trial

2021 ◽  
Vol 11 (4) ◽  
pp. 464
Author(s):  
Elsje de Villiers ◽  
Thomas Stone ◽  
Nai-Wei Wang ◽  
Viswadeep Sarangi ◽  
Adar Pelah ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Intervention Group ◽  
Pain Syndrome ◽  
Feasibility Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Still Images ◽  
Novel Approach ◽  
Motor Neglect ◽  
Chronic Pain Conditions

Background: Motor neglect occurs in patients with chronic pain conditions. Virtual environments (VE) help rehabilitation through biofeedback and improving motivation. Aim: To assess the feasibility of a VE for patients with motor neglect with chronic pain. Methods: 10 subjects with chronic pain (Fibromyalgia, Sciatica, and Complex Regional Pain Syndrome) underwent a treadmill task three times per week for two weeks. Groups were randomized to receive real-time biofeedback from the VE (intervention) or shown still images (control). Primary outcomes were: (i) distance walked at baseline compared to the final 5 min cycle of week 2; (ii) the Lower Extremity Functional Index (LEFI) questionnaire. A satisfaction questionnaire was used. Follow up was to 24 weeks. Results: Total distance walked was significantly higher in the intervention group (p < 0.05), and 33% (2/6) of the intervention group had a clinically important LEFI improvement compared to 0/4 in the control group at week 2. No secondary outcome measures demonstrated any significant differences. The intervention received high satisfaction scores, significantly greater than the control group at week 24. No harms were recorded. Discussion: This feasibility study showed that VE and treadmill-walking improved walking distances and function for subjects with motor neglect. This is a promising novel approach and requires further validation through larger study.

scholarly journals Use of standardised outcome measures in adult mental health services

2006 ◽  
Vol 189 (4) ◽  
pp. 330-336 ◽  
Author(s):  
Mike Slade ◽  
Paul McCrone ◽  
Elizabeth Kuipers ◽  
Morven Leese ◽  
Sharon Cahill ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Outcome Measures ◽  
Service Use ◽  
Psychiatric Inpatient ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Adult Mental Health

BackgroundRoutine use of standardised outcome measures is not universal.AimsTo evaluate the effectiveness of standardised outcome assessment.MethodA randomised controlled trial, involving 160 representative adult mental health patients and paired staff (ISRCTN16971059). The intervention group (n=101) (a) completed monthly postal questionnaires assessing needs, quality of life, mental health problem severity and therapeutic alliance, and (b) received 3-monthly feedback. The control group (n=59) received treatment as usual.ResultsThe intervention did not improve primary outcomes of patient-rated unmet need and of quality of life. Other subjective secondary outcome measures were also not improved. The intervention reduced psychiatric inpatient days (3.5 v. 16.4 mean days, bootstrapped 95% CI 1.6-25.7), and hence service use costs were £2586 (95% CI 102-5391) less for intervention-group patients. Net benefit analysis indicated that the intervention was cost-effective.ConclusionsRoutine use of outcome measures as implemented in this study did not improve subjective outcomes, but was associated with reduced psychiatric inpatient admissions.

scholarly journals Efficacy and Safety of Traditional Chinese medicine in patients with acute exacerbation of idiopathic pulmonary fibrosis: study protocol for randomized, controlled, exploratory clinical trial

2021 ◽  
Author(s):  
Hailong Zhang ◽  
Jiansheng Li ◽  
Wen Guo ◽  
Lu Wang ◽  
Dong Zhang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Acute Exacerbation ◽  
Secondary Outcome ◽  
Control Group ◽  
Efficacy And Safety ◽  
Arterial Blood

Abstract Background: At present, there is short of effective treatment for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF). The treatment of IPF with Traditional Chinese medicine (TCM) has some advantages. However, the evidence is unclear whether TCM can be recommended as an effective therapy to treat AE-IPF. The purpose of the study is to explore the efficacy and safety of TCM for patients with AE-IPF.Methods: A randomized, double-blind, placebo-controlled, exploratory clinical trial will be performed. A total of 80 patients diagnosed AE-IPF will be randomized into the intervention or control group. In addition to conventional treatment, the intervention group will be treated with Kangxianhuanji granule, and the control group will be given a placebo granule. The administration frequency is 10g each time and two times daily. After 4 weeks of treatment, the patients were followed up for 12 weeks. The primary outcomes are treatment failure rate and all-cause of mortality. Secondary outcome measures will include the length of hospitalization, overall survival, acute exacerbation rate, intubation rate, Modified British Medical Research Council (mMRC) score, and the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis (SGRQ-I) score, and arterial blood gas analysis.Discussion: TCM may be beneficial in IPF. However, it has never been evaluated in patients with AE-IPF, who are incredibly prone to respiratory failure and have a high mortality rate. It is the first clinical trial to explore the efficacy and safety of TCM in the treatment of AE-IPF. This result will provide a basis for further study, which provide a high-quality evidence for the treatment of AE-IPF with TCM.Trial registration: Chinese Clinical Trial Registry, ChiCTR1900026289. Registered 29 September 2019, http://www.chictr.org.cn/index.aspx.

An Internet-based health gateway device for interactive communication and automatic data uploading: Clinical efficacy for type 2 diabetes in a multi-centre trial

2016 ◽  
Vol 23 (6) ◽  
pp. 595-604 ◽  
Author(s):  
Jae Hyoung Cho ◽  
Hun-Sung Kim ◽  
Seung Hyun Yoo ◽  
Chang Hee Jung ◽  
Woo Je Lee ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthcare System ◽  
Glucose Control ◽  
Large Scale ◽  
Diabetes Management ◽  
Intervention Group ◽  
Diabetes Control ◽  
Control Group ◽  
Anthropometric Parameters ◽  
Automatic Data

Introduction The aim of this study was to improve the quality of diabetes control and evaluate the efficacy of an Internet-based integrated healthcare system for diabetes management and safety. Methods We conducted a large-scale, multi-centre, randomized clinical trial involving 484 patients. Patients in the intervention group ( n = 244) were treated with the Internet-based system for six months, while the control group ( n = 240) received the usual outpatient management over the same period. HbA1c, blood chemistries, anthropometric parameters, and adverse events were assessed at the beginning of the study, after three months, and the end of the study. Results There were no initial significant differences between the groups with respect to demographics and clinical parameters. Upon six-month follow-up, HbA1c levels were significantly decreased from 7.86 ± 0.69% to 7.55 ± 0.86% within the intervention group ( p < 0.001) compared to 7.81 ± 0.66% to 7.70 ± 0.88% within the control group. Postprandial glucose reduction was predominant. A subgroup with baseline HbA1c higher than 8% and good compliance achieved a reduction of HbA1c by 0.8 ± 1.05%. Glucose control and waist circumference reduction were more effective in females and subjects older than 40 years of age. There were no adverse events associated with the intervention. Discussion This e-healthcare system was effective for glucose control and body composition improvement without associated adverse events in a multi-centre trial. This system may be effective in improving diabetes control in the general population.

scholarly journals Donepezil for mild cognitive impairment in Parkinson’s disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Kyoungwon Baik ◽  
Seon Myeong Kim ◽  
Jin Ho Jung ◽  
Yang Hyun Lee ◽  
Seok Jong Chung ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Treatment Group ◽  
Outcome Measures ◽  
Rating Scale ◽  
Secondary Outcome ◽  
Control Group ◽  
Significant Difference

AbstractWe investigated the efficacy of donepezil for mild cognitive impairment in Parkinson’s disease (PD-MCI). This was a prospective, non-randomized, open-label, two-arm study. Eighty PD-MCI patients were assigned to either a treatment or control group. The treatment group received donepezil for 48 weeks. The primary outcome measures were the Korean version of Mini-Mental State Exam and Montreal Cognitive Assessment scores. Secondary outcome measures were the Clinical Dementia Rating, Unified Parkinson’s Disease Rating Scale part III, Clinical Global Impression scores. Progression of dementia was assessed at 48-week. Comprehensive neuropsychological tests and electroencephalography (EEG) were performed at baseline and after 48 weeks. The spectral power ratio of the theta to beta2 band (TB2R) in the electroencephalogram was analyzed. There was no significant difference in the primary and secondary outcome measures between the two groups. However, the treatment group showed a significant decrease in TB2R at bilateral frontotemporoparietal channels compared to the control group. Although we could not demonstrate improvements in the cognitive functions, donepezil treatment had a modulatory effect on the EEG in PD-MCI patients. EEG might be a sensitive biomarker for detecting changes in PD-MCI after donepezil treatment.

scholarly journals Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ian Glaspole ◽  
Francesco Bonella ◽  
Elena Bargagli ◽  
Marilyn K. Glassberg ◽  
Fabian Caro ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Adverse Events ◽  
Treatment Discontinuation ◽  
Efficacy And Safety ◽  
Data Set ◽  
Proactive Management ◽  
Comorbidity Burden ◽  
Rate Of Decline ◽  
The Impact

Abstract Background Idiopathic pulmonary fibrosis (IPF) predominantly affects individuals aged > 60 years who have several comorbidities. Nintedanib is an approved treatment for IPF, which reduces the rate of decline in forced vital capacity (FVC). We assessed the efficacy and safety of nintedanib in patients with IPF who were elderly and who had multiple comorbidities. Methods Data were pooled from five clinical trials in which patients were randomised to receive nintedanib 150 mg twice daily or placebo. We assessed outcomes in subgroups by age < 75 versus ≥ 75 years, by < 5 and ≥ 5 comorbidities, and by Charlson Comorbidity Index (CCI) ≤ 3 and > 3 at baseline. Results The data set comprised 1690 patients. Nintedanib reduced the rate of decline in FVC (mL/year) over 52 weeks versus placebo in patients aged ≥ 75 years (difference: 105.3 [95% CI 39.3, 171.2]) (n = 326) and < 75 years (difference 125.2 [90.1, 160.4]) (n = 1364) (p = 0.60 for treatment-by-time-by-subgroup interaction), in patients with < 5 comorbidities (difference: 107.9 [95% CI 65.0, 150.9]) (n = 843) and ≥ 5 comorbidities (difference 139.3 [93.8, 184.8]) (n = 847) (p = 0.41 for treatment-by-time-by-subgroup interaction) and in patients with CCI score ≤ 3 (difference: 106.4 [95% CI 70.4, 142.4]) (n = 1330) and CCI score > 3 (difference: 129.5 [57.6, 201.4]) (n = 360) (p = 0.57 for treatment-by-time-by-subgroup interaction). The adverse event profile of nintedanib was generally similar across subgroups. The proportion of patients with adverse events leading to treatment discontinuation was greater in patients aged ≥ 75 years than < 75 years in both the nintedanib (26.4% versus 16.0%) and placebo (12.2% versus 10.8%) groups. Similarly the proportion of patients with adverse events leading to treatment discontinuation was greater in patients with ≥ 5 than < 5 comorbidities (nintedanib: 20.5% versus 15.7%; placebo: 12.1% versus 10.0%). Conclusions Our findings suggest that the effect of nintedanib on reducing the rate of FVC decline is consistent across subgroups based on age and comorbidity burden. Proactive management of adverse events is important to reduce the impact of adverse events and help patients remain on therapy. Trial registration: ClinicalTrials.gov NCT00514683, NCT01335464, NCT01335477, NCT02788474, NCT01979952.

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