scholarly journals Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial

Sensors ◽  
2020 ◽  
Vol 20 (18) ◽  
pp. 5129
Author(s):  
Renan L. Monteiro ◽  
Jane S.S.P. Ferreira ◽  
Érica Q. Silva ◽  
Asha Donini ◽  
Ronaldo H. Cruvinel-Júnior ◽  
...  
Keyword(s):  
Diabetic Neuropathy ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Recruitment Rate ◽  
Activity Level ◽  
Foot Health ◽  
Supervised Exercise ◽  
Over Time

Foot-ankle strengthening and mobility exercises are part of international guideline recommendations for people at risk of diabetic foot disease. We examined the feasibility and preliminary efficacy of a 12-week foot-ankle exercise program on clinical, functional and biomechanical outcomes in people with diabetic neuropathy (DPN). We randomly allocated 30 people with DPN to usual care (control) or usual care plus a supervised exercise program (intervention). For feasibility, we assessed recruitment rate and participant adherence and satisfaction. For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests (p < 0.05). In 52 weeks, we recruited 45 eligible participants (0.90/week). Program adherence was 80% and participants’ satisfaction had a mean (SD) of 4.57 (0.70) out of 5. The intervention group significantly improved on toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures increased over time; controls showed significantly increased heel peak pressures and force. The exercise program was feasible, based on a moderate recruitment rate and an adherent and satisfied population, and the intervention showed several positive preliminary effects over time compared to usual care.

scholarly journals Foot-ankle functional outcomes of using the Diabetic Foot Guidance System (SOPeD) for people with diabetic neuropathy: a feasibility study for the single-blind randomized controlled FOotCAre (FOCA) trial I

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Ronaldo H. Cruvinel Júnior ◽  
Jane S. S. P. Ferreira ◽  
Raquel I. Beteli ◽  
Érica Q. Silva ◽  
Jady L. Veríssimo ◽  
...  
Keyword(s):  
Diabetic Neuropathy ◽  
Usual Care ◽  
Diabetic Foot ◽  
Intervention Group ◽  
Exercise Program ◽  
Dropout Rate ◽  
Guidance System ◽  
Control Group ◽  
Foot Health ◽  
Perceived Safety

Abstract Background Diabetic neuropathy dramatically affects musculoskeletal structure and function of the lower limbs by impairing their muscle strength and mobility. Specific muscle strengthening through physiotherapy strategies appears to be promising; however, adherence to physiotherapy treatment is low in people with chronic diseases. Thus, an internet-based foot-ankle exercise program was created as a potential telerehabilitation alternative for people with diabetes to improve their self-monitoring and self-care management. This study assessed the feasibility, safety, acceptability, and changes in foot health and neuropathy symptoms in people with diabetes after 12 weeks of the intervention program with the Sistema de Orientação ao Pé diabético - Diabetic Foot Guidance System (SOPeD). Methods Fourteen individuals were recruited and randomized to either the usual care (control group) or usual care plus an internet-based foot-ankle exercise program through SOPeD (intervention group) three times per week for 12 weeks. For feasibility, we assessed contact and recruitment rates per week; program adherence, determined as completing over 70% of the 36 sessions; and participant satisfaction and safety assessed through a questionnaire and scored on a 5-point Likert scale. We assessed changes in neuropathy symptoms and foot health and functionality from baseline to 12 weeks estimating differences or median of differences and 95% confidence intervals in the intervention group. Results In 24 weeks, of the 822 patients in the database, 192 were contacted, 65 were assessed for eligibility, and 20 were considered eligible. The recruitment rate was 0.83 participants per week. Fourteen out of the 20 eligible participants agreed to participate, resulting in recruitment success of 70%. Adherence to the program was 66.7%, and there was no dropout. Participants’ median level of satisfaction was 5.0 (IQR: 4.5–5.0) and perceived safety was 5.0 (IQR: 5.0–5.0). Conclusion The internet-based foot-ankle exercise program using SOPeD is feasible, satisfactory, and safe. Although this study had moderate adherence and a zero-dropout rate, recruitment needs to be improved in the larger trial. Trial registration ClinicalTrials.gov, NCT04011267. Registered on 8 July 2019.

scholarly journals Impact of physical exercise on cardiotoxicity and cardiac health outcomes in women with breast cancer undergoing anthracycline-containing chemotherapy: a study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Pedro Antunes ◽  
Dulce Esteves ◽  
Célia Nunes ◽  
Francisco Sampaio ◽  
Antonio Ascensão ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Control Group ◽  
Supportive Cancer Care ◽  
Cardiac Health ◽  
Randomized Controlled ◽  
Clinical Biomarkers ◽  
Supervised Exercise

Abstract Background: Anthracyclines are chemotherapeutic agents frequently used in breast cancer (BC) treatment. Although improving disease-free and overall survival, the use of anthracyclines is associated with a cumulative risk of cardiac toxicity. Preventive strategies to optimize and balance cardiac health are needed, being exercise proposed as a potential non-pharmacological approach for counteracting of anthracycline-related cardiotoxicity (ARC). Despite most of the data analysing the role of exercise against cardiac toxicity and dysfunction caused by anthracyclines derived from animal studies, human studies claim for more accurate and valuable clinical biomarkers. Moreover, clinical trials in real-world setting and large samples are of pivotal importance. Methods: This protocol describes a two-arm prospective randomized controlled trial that will explore the cardioprotective effect of a structured exercise program against ARC in women with BC. Eighty-six adult women with early BC and with a therapeutic decision to receive anthracycline-containing chemotherapy (ACT) will be randomly assigned (1:1) to an intervention group or to a control group. Patients allocated to the intervention group will perform a 3-weekly supervised exercise program combining resistance and aerobic training with progressive intensity (light-to-vigorous), during the overall ACT. The control group will receive standard BC care. Primary outcomes related to cardiac (dys)function will be circulating N-terminal pro-brain natriuretic peptide (NT-proBNP) levels, resting left ventricular (LV) longitudinal strain, and resting LV ejection fraction. Secondary outcomes will include the assessment of resting blood pressure, resting heart rate (HR), resting HR variability (HRV) and recovery HR. Exploratory outcomes include physical function outcomes, self-reported physical activity level, health related to quality of life and fatigue. Data will be obtained at baseline (t0), after the end of anthracycline-treatment (t1), and three months after t2 (t2). Additionally, NT-proBNP levels will be measured between 1-24 hours prior to each anthracycline-treatment cycle. Discussion: The implementation of the present study design, using novel clinical biomarkers and “between” outcomes’ associations, will help to understand the effectiveness of structured exercise interventions at mitigating ARC, further contributing to the improvement of supportive cancer care. Trial registration: ISRCTN, ISRCTN32617901. Registered on 24 October 2018. Last updated on 11 January 2019, https://doi.org/10.1186/ISRCTN32617901. Keywords: Breast cancer, cardiotoxicity, cardiac healthcare, supervised exercise, supportive cancer care.

scholarly journals INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e029185
Author(s):  
Richard Collings ◽  
Jennifer A Freeman ◽  
Jos Latour ◽  
Patricia Jane Vickery ◽  
Sam Glasser ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Diabetic Neuropathy ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Control Group ◽  
Foot Ulceration ◽  
Randomised Controlled

IntroductionFoot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration.AimThis study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.Methods and analysisThis study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention.Ethics and disseminationThe study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications.Trials registration numberISRCTN16011830; Pre-results.

scholarly journals Peer-led exercise program for ageing adults to improve physical functions - a randomized trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
D. R. Bouchard ◽  
J. V. Olthuis ◽  
V. Bouffard-Levasseur ◽  
C. Shannon ◽  
T. McDonald ◽  
...  
Keyword(s):  
Physical Function ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Control Group ◽  
Walk Test ◽  
Blood Draw ◽  
Chair Stand ◽  
Significant Difference ◽  
Physical Functions

Abstract Background A peer-led exercise program is one way to empower people sharing similar characteristics to encourage others to be active, but there is a lack of evidence that these programs have physical function and other benefits when delivered to ageing adults. Methods This randomized controlled trial lasting 12 weeks proposed an exercise peer-led program offered to 31 adults aged 50 and above, twice a week, by a trained leader of the same age from March to May 2019. The program was offered for free with limited space and equipment. Valid tests of physical function (e.g., 30-s chair stand, 6-min walk test) were used to assess the functional benefits. Psychosocial outcomes were assessed using self-reported questionnaires and metabolic outcomes via a fasted blood draw. Results A significant difference was found between pre-and post-values in most physical function tests in the intervention group (all p < 0.05). When adjusted for potential confounders, the intervention group was significantly associated with a more significant improvement on the chair stand test (ß = .26; p < 0.001; r2 = 0.26), the arm curl (ß = .29; p < 0.001; r2 = 0.49), as well as the 6-min walk test (ß = -.14; p < 0.001; r2 = 0.62) compared with the control group. Using repetitive measures generalized linear model, the interaction between the changes and the group was significant for all three tests. Benefits were also observed for participants’ stress level and perceived health in the intervention group compared to the control. Finally, no significant difference was observed between groups for metabolic health. Conclusions The current work suggests that a 12-week peer-led exercise program can improve physical function for adults age 50 and above. Trial registration NCT03799952(ClinicalTrials.gov) 12/20/2018.

Educational intervention to adopt selective laser trabeculoplasty as first-line glaucoma treatment: Randomized controlled trial: Educational intervention on selective laser trabeculoplasty

2021 ◽  
pp. 112067212110183
Author(s):  
Evelyn Tran ◽  
Carina Sanvicente ◽  
Lisa A Hark ◽  
Jonathan S Myers ◽  
Qiang Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Educational Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Selective Laser Trabeculoplasty ◽  
First Line ◽  
Randomized Controlled ◽  
Laser Trabeculoplasty ◽  
Glaucoma Treatment

Purpose: To determine the efficacy of an educational intervention on patient adoption and attitudes toward selective laser trabeculoplasty (SLT) as first-line treatment for glaucoma. Methods: This study is a randomized controlled trial. Subjects include 33 patients within 1-year diagnosis of either primary open-angle glaucoma, ocular hypertension, or pseudoexfoliation syndrome. After informed consent, subjects were randomly assigned to a Usual Care or Educational Intervention group. All subjects completed a pre-intervention questionnaire. The Educational Intervention group was shown a slideshow presentation and a 3-min video and given a post-intervention questionnaire. Follow-up examinations were reviewed for 6 months to determine subject completion of SLT, the primary outcome. Secondary outcomes include assessment of attitude toward SLT before and after intervention. Results: Age, gender, and baseline characteristics between the groups did not differ. The Usual Care group had a higher proportion of African Americans (77% vs 31%, p = 0.04). At 6 months following the intervention, 63% of subjects underwent SLT compared to 35% of Usual Care subjects ( p = 0.12). Older age was associated with decreased SLT uptake (OR 0.90, 95% CI 0.82–0.99, p = 0.03). Prior to the intervention, there were no differences in attitudes of both groups regarding SLT therapy. Nineteen percent of Educational Intervention subjects changed positively toward SLT ( p = 0.08) and 50% scheduled an SLT appointment after intervention ( p = 0.005). Conclusions: A slideshow and video-based educational intervention may positively enhance patient adoption of SLT. Clinical trial registration name, number, URL: Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment, NCT03365778, https://clinicaltrials.gov/ct2/show/NCT03365778

scholarly journals OP0159 EFFICACY OF COMPREHENSIVE TECHNOLOGY-ASSISTED HOME-BASED EXERCISE IN ANKYLOSING SPONDYLITIS: A RANDOMIZED, CONTROLLED TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 100.3-100
Author(s):  
Y. Wang ◽  
X. Liu ◽  
Y. Shi ◽  
X. Ji ◽  
W. Wang ◽  
...  
Keyword(s):  
Exercise Intervention ◽  
Medical Center ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Group Differences ◽  
Control Group ◽  
Home Based ◽  
The Mean

Background:Clinical practice guidelines recommend that exercise is an essential component in the self-management of Ankylosing Spondylitis (AS). Attending supervised interventions requiring periodic medical center visits can be burdensome and patients may decline participation, whereas, effective home-based exercise interventions that do not need regular medical center visits are likely to be more accessible and acceptable for patients with AS. Recently, increasing evidences have been accumulated that the wearable devices could facilitate patients with inflammatory arthritis by giving exercise instructions and improving self-efficacy. Therefore, patients with AS may benefit from an effective technology-assisted home-based exercise intervention.Objectives:To investigate the efficacy of a comprehensive technology-assisted home-based exercise intervention on disease activity in patients with AS.Methods:This study was a 16-week assessor-blinded, randomized, waiting-list controlled trial (ChiCTR1900024244). Patients with AS were randomly allocated to the home-based exercise intervention group and the waiting-list control group. A 16-week comprehensive exercise program consisting of a moderate intensity (64%-76% HRmax) aerobic training for 30min on 5 days/week and a functional training for 60min on 3 days/week was given to patients in the intervention group immediately after randomization, with 1.5h training sessions for two consecutive days by a study physical therapist at baseline and Week 8. The aerobic exercise intensity was controlled by a Mio FUSE Wristband with a smartphone application. The functional training consisted of the posture training, range of motion exercises, strength training, stability training and stretching exercises. Patients in control group received standard care during the 16-week follow-up and started to receive the exercise program at Week 16. The primary outcome was ASDAS at Week 16. The secondary outcomes were BASDAI, BASFI, BASMI, ASAS HI, peak oxygen uptake, body composition and muscle endurance tests. The mean difference between groups in change from baseline was analyzed with the analysis of covariance.Results:A total of 54 patients with AS were enrolled (26 in intervention group and 28 in control group) and 46 (85.2%) patients completed the 16-week follow-up. The mean difference of ASDAS between groups in change from baseline to 16-week follow-up was −0.2 (95% CI, −0.4 to 0.003, P = 0.032), and the mean change from baseline was -0.4 (95% CI, -0.5 to -0.2) in the intervention group vs -0.1 (95% CI, -0.3 to 0.01) in the control group, respectively. Significant between-group differences were found between groups for BASDAI (−0.5 [95% CI, −0.9 to −0.2], P = 0.004), BASMI (−0.7 [95% CI, −1.1 to −0.4], P <0.001), BASFI (−0.3 [95% CI, −0.6 to 0.01], P=0.035), peak oxygen uptake (2.7 [95% CI, 0.02 to 5.3] ml/kg/min, P=0.048) and extensor endurance test (17.8 [95% CI, 0.5 to 35.2]s, P=0.044) at Week 16. Between-group differences were detected in ASAS HI (−0.9 [95% CI, −1.7 to −0.1], P=0.030), body fat percentage (−1.0 [95% CI, −2.0 to −0.01] %, P=0.048) and visceral adipose tissue (−4.9 [95% CI, −8.5 to −1.4] cm2, P=0.008) at Week 8, but not at Week 16. No significant between-group differences were detected in the total lean mass, time up and go test and the flexor endurance test during the follow-up.Conclusion:Comprehensive technology-assisted home-based exercise has been shown to have beneficial effects on disease activity, physical function, spinal mobility, aerobic capacity, and body composition as well as in improving fatigue and morning stiffness of patients with AS.References:[1]van der Heijde D, Ramiro S, Landewé R, et al. Ann Rheum Dis 2017;76:978–991.Disclosure of Interests:None declared

Sustained impact of a sleep intervention and moderators of treatment outcome for children with ADHD: a randomised controlled trial

2019 ◽  
Vol 50 (2) ◽  
pp. 210-219 ◽  
Author(s):  
E. Sciberras ◽  
M. Mulraney ◽  
F. Mensah ◽  
F. Oberklaid ◽  
D. Efron ◽  
...  
Keyword(s):  
Usual Care ◽  
Sleep Problem ◽  
Controlled Trial ◽  
Parent Report ◽  
Daily Functioning ◽  
Adhd Medication ◽  
Randomised Controlled ◽  
Severe Sleep Problem ◽  
Over Time

AbstractBackgroundWe aim to (1) determine whether a behavioural sleep intervention for children with attention-deficit/hyperactivity disorder (ADHD) leads to sustained benefits; and (2) examine the factors associated with treatment response.MethodsThis study was a randomised controlled trial of 244 children (5–13 years) with ADHD from Victoria, Australia. All participants had a moderate/severe sleep problem that met American Academy of Sleep Medicine criteria for an eligible sleep disorder by parent report. The two-session intervention covered sleep hygiene and standardised behavioural strategies. The control group received usual care. Parent- and teacher-reported outcomes at 12 months included sleep, ADHD severity, quality of life, daily functioning, behaviour, and parent mental health. Adjusted mixed effects regression analyses examined 12 month outcomes. Interaction analyses were used to determine moderators of intervention outcomes over time. The trial was registered with ISRCTN, http://www.controlled-trials.com (ISRCTN68819261).ResultsIntervention children were less likely to have a moderate/severe sleep problem by parent report at 12 months compared to usual care children (28.4% v. 46.5%, p = 0.03). Children in the intervention group fared better than the usual care group in terms of parent-reported ADHD symptoms (Cohen's d: −0.3, p < 0.001), quality of life (d: 0.4, p < 0.001), daily functioning (d: −0.5, p < 0.001), and behaviour (d: −0.3, p = 0.005) 12 months later. The benefits of the intervention over time in terms of sleep were less for children not taking ADHD medication and children with parents experiencing depression.ConclusionsA behavioural sleep intervention for ADHD is associated with small sustained improvements in child wellbeing. Children who are not taking ADHD medication or have parents with depression may require follow-up booster sleep sessions.

Effect of Artificial Intelligence on Nutritional Status of children post cardiac surgery; A Randomized Controlled Trial (Preprint)

2022 ◽  
Author(s):  
Maryam Zahid ◽  
Ume Sughra
Keyword(s):  
Nutritional Status ◽  
Usual Care ◽  
Usual Care Group ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
Randomized Controlled ◽  
Nutritional Status Of Children ◽  
Post Cardiac Surgery

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.

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