Impact of a mobile telerehabilitation solution on metabolic health outcomes and rehabilitation adherence in obese patients: a randomised controlled trial (Preprint)

2021 ◽  
Author(s):  
François Bughin ◽  
Gaspard Bui ◽  
Bronia Ayoub ◽  
Leo Blervaque ◽  
Didier Saey ◽  
...  
Keyword(s):  
Body Composition ◽  
Health Outcomes ◽  
Usual Care ◽  
Metabolic Parameters ◽  
Therapeutic Education ◽  
Controlled Study ◽  
Care Group ◽  
Obese Patients ◽  
Significant Group ◽  
Randomised Controlled

BACKGROUND Obesity is a challenge for public health. Combining exercise training, nutrition and therapeutic education in a metabolic rehabilitation (MR) is recommended for obesity management. Yet, randomized controlled study-based evidences are lacking. In addition MR is associated with poor patient’s adherence. Mobile Health (mHealth) devices improve the access to the MR components. OBJECTIVE Thus, a telerehabilitation (TR) solution could deliver a feasible multidisciplinary MR in obese patients and improve fat mass (FM), metabolic parameters and quality of life versus usual care. METHODS This was a randomised, controlled, parallel-design study. Fifty obese (body mass index BMI > 30 kg/m²) patients were included in a telerehabilitation group (TRG) or a usual care group (UCG) for 12 weeks. Patients underwent biometric impedance analyses, metabolic exercise tests, actimetry, QOL and satisfaction questionnaires. The primary outcome was the changes in body composition. Secondary outcomes were BW, metabolic parameters, exercise capacity, QOL, patient’s adhesion and satisfaction. RESULTS Forty-nine patients completed the study. No significant group*time interaction was found for FM. Compared to UCG, TRG patients significantly improved waist to hip ratio and EQVOD’s physical impact. Significant time effects occurred for body composition, 6MWT distance, exercise metabolism, sedentary time and QOL (p<0,05). Adherence (95%) and satisfaction in the TRG were good. CONCLUSIONS In obese adults, TR was able to deliver a full multidisciplinary rehabilitation in obese patients and improved their health outcomes. Given the patient’s adherence and satisfaction, pragmatic programs should consider mHealth devices to improve the access to MR. Further studies are warranted to establish the additional TR benefits versus usual care. CLINICALTRIAL Mobile Tele-rehabilitation Solution for Obese Patients NCT03396666 https://clinicaltrials.gov/ct2/show/NCT03396666?term=03396666&draw=2&rank=1

scholarly journals Randomised controlled study of two counselling models at the Swedish alcohol helpline: Effectiveness and sustainability outcomes at 12-month follow-up

2021 ◽  
pp. 145507252110078
Author(s):  
Thi-Thuy-Dung Nguyen ◽  
Eleonor Säfsten ◽  
Filip Andersson ◽  
Maria Rosaria Galanti
Keyword(s):  
Alcohol Use ◽  
Usual Care ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Risk Level ◽  
Care Group ◽  
Structured Intervention ◽  
Randomised Controlled ◽  
Level Reduction

Aim: This two-arm parallel randomised controlled trial explored the effectiveness of a brief counselling model compared with the usual multi-session counselling at an alcohol telephone helpline. Methods: A total of 320 callers who contacted the Swedish Alcohol Helpline (SAH) because of hazardous or harmful alcohol use were randomised to either brief structured intervention (self-help booklet plus one proactive call) or usual care (multi-session telephone counselling). The primary outcome was a downward shift in risk level at 12-month follow-up compared with baseline, based on self-reports. Sustained risk level reduction throughout the whole follow-up was also assessed as secondary outcome. Results: Both interventions were significantly associated with a shift to a lower level of risky alcohol use (75% among participants in the brief structured intervention, and 70% in the usual care group) after 12 months. There was no difference between the two interventions in the proportions changing alcohol use or sustaining risk level reduction. Conclusion: In the context of telephone helplines, minimal and extended interventions appear to be equally effective in promoting long-term change in alcohol use.

scholarly journals Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)

2019 ◽  
Author(s):  
Jeanette Trøstrup ◽  
Lone Ramer Mikkelsen ◽  
Poul Frost ◽  
Annett Dalbøge ◽  
Mette Terp Høybye ◽  
...  
Keyword(s):  
Usual Care ◽  
Mixed Model ◽  
Exercise Intervention ◽  
Randomised Trial ◽  
Self Report ◽  
Controlled Study ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
First Choice ◽  
Randomised Controlled

Abstract Background: In Denmark, exercise therapy in combination with work modifications is the first choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will reduce (I) shoulder complaints and (II) occupational shoulder exposures more effectively than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care). Methods: A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-oriented counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6 month follow-up (hypothesis I), and the mean number of minutes/day with the arm elevated > 60° shortly after end of intervention (hypothesis II). We will use mixed model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle. Discussion: Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation. Trial registration: The trial was registered at Clinicaltrials.gov on 18 May 2017 (ID: NCT03159910). Keywords: Exercise, Intervention, Mechanical exposure, Occupation, Randomised controlled trial, Shoulder, Training programme.

The Natural History of Back Pain after a Randomised Controlled Trial of Acupuncture Vs Usual Care – Long Term Outcomes

2007 ◽  
Vol 25 (4) ◽  
pp. 121-129 ◽  
Author(s):  
Stephanie L Prady ◽  
Kate Thomas ◽  
Lisa Esmonde ◽  
Simon Crouch ◽  
Hugh MacPherson
Keyword(s):  
Back Pain ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Bodily Pain ◽  
Care Group ◽  
Long Term Outcomes ◽  
Short Term Treatment ◽  
Randomised Controlled

Introduction There is growing evidence about the effectiveness of acupuncture in the short term treatment of chronic low back pain but little is known about long term outcomes. To address this question we followed up participants of a past randomised controlled trial of acupuncture to assess outcomes after 5.5 to 7 years. Methods A postal questionnaire assessing pain, quality of life, disability, experience with back pain and healthcare resource use was sent to all 239 participants of the York Acupuncture for Back Pain trial. Results Response to the survey was low at 43.9%. Pain measured by the SF-36 Bodily Pain dimension was maintained in the acupuncture group since the last follow up 3.5 to 5 years previously. The usual care group had improved over the intervening years and there was now no evidence of a difference between the groups (difference −0.4 points, 95% confidence interval −10.1 to 9.7). The results were unchanged on sensitivity analysis using multiple imputation. In both groups back pain had not completely resolved and worry about back health was moderate. Physiotherapy and acupuncture were used at similar rates for continuing treatment. Discussion We theorise that exposure to a short course of acupuncture speeds natural recovery from a back pain episode, but improvements plateau after two years. Acupuncture is often accessed privately for long term management of back pain but is rarely available within the health service. While our study methods were robust, the low response rate means that our findings should be interpreted with caution.

Using Moxibustion in Primary Healthcare to Correct Non-Vertex Presentation: A Multicentre Randomised Controlled Trial

2013 ◽  
Vol 31 (1) ◽  
pp. 31-38 ◽  
Author(s):  
Jorge Vas ◽  
José Manuel Aranda-Regules ◽  
Manuela Modesto ◽  
María Ramos-Monserrat ◽  
Mercedes Barón ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Primary Healthcare ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Acupuncture Point ◽  
Care Group ◽  
Moxibustion Group ◽  
Vertex Presentation ◽  
Randomised Controlled

Objective To compare the effectiveness of additional moxibustion at point BL67 with moxibustion at a non-specific acupuncture point and with usual care alone to correct non-vertex presentation. Methods This was a multicentre randomised controlled trial in which 406 low-risk pregnant women with a fetus in ultrasound breech presentation, with a gestational age of 33–35 weeks, were assigned to (1) true moxibustion at point BL67 plus usual care; (2) moxibustion at SP1, a non-specific acupuncture point (sham moxibustion) plus usual care; or (3) usual care alone. The primary outcome was cephalic presentation at birth. Women were recruited at health centres in primary healthcare. Results In the true moxibustion group, 58.1% of the full-term presentations were cephalic compared with 43.4% in the sham moxibustion group (RR 1.34, 95% CI 1.05 to 1.70) and 44.8% of those in the usual care group (RR 1.29, 95% CI 1.02 to 1.64). The reduction in RR of the primary outcome in women allocated to the true moxibustion group compared with the usual care group was 29.7% (95% CI 3.1% to 55.2%) and the number needed to treat was 8 (95% CI 4 to 72). There were no severe adverse effects during the treatment. Conclusions Moxibustion at acupuncture point BL67 is effective and safe to correct non-vertex presentation when used between 33 and 35 weeks of gestation. We believe that moxibustion represents a treatment option that should be considered to achieve version of the non-vertex fetus. Trial Registration Current Controlled Trials ISRCTN10634508.

scholarly journals Home-based Reach-to-Grasp training for people after stroke is feasible: a pilot randomised controlled trial

2016 ◽  
Vol 31 (7) ◽  
pp. 891-903 ◽  
Author(s):  
AJ Turton ◽  
P Cunningham ◽  
F van Wijck ◽  
HJM Smartt ◽  
CA Rogers ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Usual Care Group ◽  
Controlled Trial ◽  
Care Group ◽  
Reach To Grasp ◽  
Arm Pain ◽  
Home Based ◽  
Wolf Motor Function Test ◽  
Randomised Controlled

Objective: To determine feasibility of a randomised controlled trial (RCT) of home-based Reach-to-Grasp training after stroke. Design: single-blind parallel group RCT. Participants: Residual arm deficit less than 12 months post-stroke. Interventions: Reach-to-Grasp training in 14 one-hour therapist’s visits over 6 weeks, plus one hour self-practice per day (total 56 hours). Control: Usual care. Main Measures: Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), pre-randomisation, 7, 12, 24 weeks post-randomisation. Results: Forty-seven participants (Reach-to-Grasp=24, usual care=23) were randomised over 17 months. Reach-to-Grasp participants received a median (IQR) 14 (13,14) visits, and performed 157 (96,211) repetitions per visit; plus 30 minutes (22,45) self-practice per day. Usual care participants received 10.5 (5,14) therapist visits, comprising 38.6 (30,45) minutes of arm therapy with 16 (6,24) repetitions of functional tasks per visit. Median ARAT scores in the reach-to-grasp group were 8.5 (3.0,24.0) at baseline and 14.5 (3.5,26.0) at 24 weeks compared to median of 4 at both time points (IQR: baseline (3.0,14.0), 24 weeks (3.0,30.0)) in the usual-care group. Median WMFT tasks completed at baseline and 24 weeks were 6 (3.0,11.5) and 8.5 (4.5,13.5) respectively in the reach-to-grasp group and 4 (3.0,10.0), 6 (3.0,14.0) in the usual care group. Incidence of arm pain was similar between groups. The study was stopped before 11 patients reached the 24 weeks assessment. Conclusions: An RCT of home-based Reach-to-Grasp training after stroke is feasible and safe. With ARAT being our preferred measure it is estimated that 240 participants will be needed for a future two armed trial.

scholarly journals Mindfulness-based cognitive therapy v. group psychoeducation for people with generalised anxiety disorder: Randomised controlled trial

2016 ◽  
Vol 209 (1) ◽  
pp. 68-75 ◽  
Author(s):  
Samuel Yeung Shan Wong ◽  
Benjamin Hon Kei Yip ◽  
Winnie Wing Sze Mak ◽  
Stewart Mercer ◽  
Eliza Yee Lai Cheung ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Usual Care ◽  
Cognitive Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Generalised Anxiety Disorder ◽  
Significant Group ◽  
Time Interaction ◽  
Group Time ◽  
Randomised Controlled

BackgroundResearch suggests that an 8-week mindfulness-based cognitive therapy (MBCT) course may be effective for generalised anxiety disorder (GAD).AimsTo compare changes in anxiety levels among participants with GAD randomly assigned to MBCT, cognitive–behavioural therapy-based psychoeducation and usual care.MethodIn total, 182 participants with GAD were recruited (trial registration number: CUHK_CCT00267) and assigned to the three groups and followed for 5 months after baseline assessment with the two intervention groups followed for an additional 6 months. Primary outcomes were anxiety and worry levels.ResultsLinear mixed models demonstrated significant group × time interaction (F(4,148) = 5.10, P = 0.001) effects for decreased anxiety for both the intervention groups relative to usual care. Significant group × time interaction effects were observed for worry and depressive symptoms and mental health-related quality of life for the psychoeducation group only.ConclusionsThese results suggest that both of the interventions appear to be superior to usual care for the reduction of anxiety symptoms.

scholarly journals Effects of Whole-Body Electromyostimulation versus High-Intensity Resistance Exercise on Body Composition and Strength: A Randomized Controlled Study

2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Wolfgang Kemmler ◽  
Marc Teschler ◽  
Anja Weißenfels ◽  
Michael Bebenek ◽  
Michael Fröhlich ◽  
...  
Keyword(s):  
Body Composition ◽  
Resistance Exercise ◽  
High Intensity ◽  
Whole Body ◽  
Controlled Study ◽  
Group Differences ◽  
Significant Group ◽  
Gold Standard Reference ◽  
Group 3 ◽  
Single Set

High-intensity (resistance) exercise (HIT) and whole-body electromyostimulation (WB-EMS) are both approaches to realize time-efficient favorable changes of body composition and strength. The purpose of this study was to determine the effectiveness of WB-EMS compared with the gold standard reference HIT, for improving body composition and muscle strength in middle-aged men. Forty-eight healthy untrained men, 30–50 years old, were randomly allocated to either HIT (2 sessions/week) or a WB-EMS group (3 sessions/2 weeks) that exercised for 16 weeks. HIT was applied as “single-set-to-failure protocol,” while WB-EMS was conducted with intermittent stimulation (6 s WB-EMS, 4 s rest; 85 Hz, 350 ms) over 20 minutes. The main outcome parameters were lean body mass (LBM) as determined via dual-energy X-ray absorptiometry and maximum dynamic leg-extensor strength (isokinetic leg-press). LBM changes of both groups (HIT 1.25 ± 1.44% versus WB-EMS0.93±1.15%) were significant (p=.001); however, no significant group differences were detected (p=.395). Leg-extensor strength also increased in both groups (HIT12.7±14.7%,p=.002, versus WB-EMS7.3±10.3%,p=.012) with no significant (p=.215) between-group difference. Corresponding changes were also determined for body fat and back-extensor strength.Conclusion. In summary, WB-EMS can be considered as a time-efficient but pricy option to HIT-resistance exercise for people aiming at the improvement of general strength and body composition.

scholarly journals Outcome of ivermectin treated mild to moderate COVID-19 cases: a single-centre, open-label, randomised controlled study

2021 ◽  
Vol 14 (2) ◽  
pp. 11-18
Author(s):  
Chinmay Saha Podder ◽  
Nandini Chowdhury ◽  
Mohim Ibne Sina ◽  
Wasim Md Mohosin Ul Haque
Keyword(s):  
Usual Care ◽  
Recovery Time ◽  
Early Stage ◽  
Controlled Study ◽  
Rt Pcr ◽  
Open Label ◽  
Total Recovery ◽  
Randomised Controlled Study ◽  
Time Required ◽  
Randomised Controlled

Background and objectives: Various existing non-antiviral drugs are being used to treat severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection based mostly on existing data from previous coronavirus outbreaks. Ivermectin is one of such agents being widely used to treat early-stage of COVID-19. This study evaluated the outcome of ivermectin treated mild to moderate COVID-19 cases compared to usual care. Methods: This open-label randomised controlled study was conducted at a sub-district (Upazila) health complex from 1st May 2020 to the end of July 2020. Consecutive RT-PCR positive eligible COVID-19 patients were randomised into control and intervention arms. In the intervention arm, ivermectin 200 micrograms/kg single dose was administered orally in addition to usual care and was followed up till recovery. Repeat RT-PCR was done on day ten since the first positive result. The end point with regard to treatment outcome was time required for the resolution of symptoms from the onset of the symptoms and following enrollement in the study. Results: A total of 62 mild to moderate COVID-19 patients were enrolled in the study. There were 30 patients in the control arm and 32 patients in the intervention arm. Total recovery time from the onset of symptoms to complete resolution of symptoms of the patients in the intervention arm was 10.09 ± 3.236 days, compared to 11.50 ± 5.32 days in the control arm (95% CI -0.860,3.627, p>. 05) and was not significantly different. The mean recovery time after enrolment in the intervention arm was 5.31 ± 2.48 days, which also did not differ significantly from the control arm of 6.33 ± 4.23 days (95% CI – 0.766, 2.808, p> 0.05). Results of negative repeat RT- PCR were not significantly different between control and intervention arms (control 90% vs intervention 95%, p>.05). Conclusion: Ivermectin had no beneficial effect on the disease course over usual care in mild to moderate COVID-19 cases. Ibrahim Med. Coll. J. 2020; 14(2): 11-18

scholarly journals Impact of pharmacist-led care on glycaemic control of patients with uncontrolled type 2 diabetes: a randomised controlled trial in Nigeria

2021 ◽  
Vol 19 (3) ◽  
pp. 2402
Author(s):  
Emmanuel A. David ◽  
Rebecca O. Soremekun ◽  
Isaac O. Abah ◽  
Roseline I. Aderemi-Williams
Keyword(s):  
Type 2 Diabetes ◽  
Glycaemic Control ◽  
Usual Care ◽  
Usual Care Group ◽  
Intervention Group ◽  
Glycated Haemoglobin ◽  
Care Group ◽  
Laboratory Parameters ◽  
Randomised Controlled

Background: Diabetes mellitus is a chronic, degenerative disease, requiring a multi-dimensional, multi-professional care by healthcare providers and substantial self-care by the patients, to achieve treatment goals. Objective: To evaluate the impact of pharmacist-led care on glycaemic control in patients with uncontrolled Type 2 Diabetes Methods: In a parallel group, single-blind randomised controlled study; type 2 diabetic patients, with greater than 7% glycated haemoglobin (A1C) were randomised into intervention and usual care groups and followed for six months. Glycated haemoglobin analyzer, lipid analyzer and blood pressure monitor/apparatus were used to measure patients’ laboratory parameters at baseline and six months. Intervention group patients received pharmacist-structured care, made up of patient education and phone calls, in addition to usual care. In an intention to treat analysis, Mann-Whitney U test was used to compare median change at six months in the primary (A1C) and secondary outcome measures. Effect size was computed and proportion of patients that reached target laboratory parameters were compared in both arms. Results: All enrolled participants (108) completed the study, 54 in each arm. Mean age was 51 (SD 11.75) and majority were females (68.5%). Participants in the intervention group had significant reduction in A1C of -0.75%, compared with an increase of 0.15% in the usual care group (p<0.001; eta-square= 0.144). The proportion of those that achieved target A1C of <7% at 6 months in the intervention and usual care group was 42.6% vs 20.8% (p=0.02). Furthermore, intervention patients were about 3 times more likely to have better glucose control; A1C<7% (aOR 2.72, 95%CI: 1.14-6.46) compared to usual care group, adjusted for sex, age, and duration of diabetes. Conclusions: Pharmacist-led care significantly improved glycaemic control in patients with uncontrolled T2DM.

Sign in / Sign up

Export Citation Format

Share Document