scholarly journals Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND): Study protocol

2017 ◽  
Vol 3 (1) ◽  
pp. 91-97 ◽  
Author(s):  
Marie-Eve Carrier ◽  
Linda Kwakkenbos ◽  
Isabelle Boutron ◽  
Joep Welling ◽  
Maureen Sauve ◽  
...  
Keyword(s):  
Exercise Intervention ◽  
Controlled Trial ◽  
Hand Function ◽  
Exercise Program ◽  
Full Scale ◽  
Feasibility Trial ◽  
Trial Participant ◽  
Trial Methodology ◽  
Patient Centered ◽  
Scleroderma Patient

Background: Significant functional impairment of the hands is nearly universal in systemic sclerosis (SSc, scleroderma). Hand exercises may improve hand function, but developing, testing and disseminating rehabilitation interventions in SSc is challenging. The Scleroderma Patient-centered Intervention Network (SPIN) was established to address this issue and has developed an online hand exercise program to improve hand function for SSc patients (SPIN-HAND). The aim of the proposed feasibility trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-HAND intervention. Design and methods: The SPIN-HAND feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with at least mild hand function limitations (Cochin Hand Function Scale ≥3) and an indicated interest in using an online hand-exercise intervention will be randomized with a 1:1 ratio to be offered to use the SPIN-HAND program or usual care for 3 months. The primary aim is to evaluate the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-HAND program. Discussion: The SPIN-HAND exercise program is a self-help tool that may improve hand function in patients with SSc. The SPIN-HAND feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-HAND program. Trial registration: ClinicalTrials.gov Identifier: NCT03092024.

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

scholarly journals Body Composition Changes Following a Concurrent Exercise Intervention in Perimenopausal Women: The FLAMENCO Project Randomized Controlled Trial

2019 ◽  
Vol 8 (10) ◽  
pp. 1678
Author(s):  
Irene Coll-Risco ◽  
Pedro Acosta-Manzano ◽  
Milkana Borges-Cosic ◽  
Daniel Camiletti-Moiron ◽  
Pilar Aranda ◽  
...  
Keyword(s):  
Body Composition ◽  
Bone Mineral Content ◽  
Bone Mineral ◽  
Mineral Content ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Exercise Program ◽  
Exercise Group ◽  
Control Group ◽  
Perimenopausal Women

We assessed the effects of a 16-week primary-care-based exercise program on body composition in perimenopausal women. The women (n = 150) were randomized into control (n = 75) or exercise (n = 75) groups. Exercise was provided in a 16-week (60 min/session, 3 days/week) concurrent program. Body composition was measured using dual-energy X-ray absorptiometry. These are secondary analyses of the FLAMENCO Project (Clinical Trials Reference NCT02358109). In the intention-to-treat analyses, the control group showed no changes in body mass index (BMI) between post- and pre-test, whereas the exercise group showed a 0.75 kg/m2 decrease in BMI (95% CI: −1.29 to −0.22; p = 0.006). Gynoid and android fat mass in control group decreased by 98.3 g and 46.1 g after the 16 weeks, whereas they decreased by 213 g and 139 g in the exercise group, respectively (95% CI: −209 to −3.86; p = 0.042 and 95% CI: −164 to −26.9; p = 0.007, respectively). The control group decreased their pelvis bone mineral content by 2.85 g in the post-test compared with the pre-test, whereas the exercise group increased it by 1.13 g (95% CI: 0.93 to 7.81; p = 0.013). Per-protocol analyses showed similar results. These analyses suggest that the exercise intervention decreased fat depositions and BMI. Exercise might improve bone mineral content in specific areas such as the pelvis.

scholarly journals Patients’ Perceptions of an Exercise Program Delivered Following Discharge From Hospital After Critical Illness (the Revive Trial)

2017 ◽  
Vol 34 (11-12) ◽  
pp. 978-984 ◽  
Author(s):  
Kathryn Ferguson ◽  
Judy M. Bradley ◽  
Daniel F. McAuley ◽  
Bronagh Blackwood ◽  
Brenda O’Neill
Keyword(s):  
Critical Illness ◽  
Qualitative Study ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Program ◽  
Exercise Group ◽  
Poor Mental Health ◽  
Discharge From Hospital ◽  
Insight Into

Background: The REVIVE randomized controlled trial (RCT) investigated the effectiveness of an individually tailored (personalized) exercise program for patients discharged from hospital after critical illness. By including qualitative methods, we aimed to explore patients’ perceptions of engaging in the exercise program. Methods: Patients were recruited from general intensive care units in 6 hospitals in Northern Ireland. Patients allocated to the exercise intervention group were invited to participate in this qualitative study. Independent semistructured interviews were conducted at 6 months after randomization. Interviews were audio-recorded, transcribed, and content analysis used to explore themes arising from the data. Results: Of 30 patients allocated to the exercise group, 21 completed the interviews. Patients provided insight into the physical and mental sequelae they experienced following critical illness. There was a strong sense of patients’ need for the exercise program and its importance for their recovery following discharge home. Key facilitators of the intervention included supervision, tailoring of the exercises to personal needs, and the exercise manual. Barriers included poor mental health, existing physical limitations, and lack of motivation. Patients’ views of outcome measures in the REVIVE RCT varied. Many patients were unsure about what would be the best way of measuring how the program affected their health. Conclusions: This qualitative study adds an important perspective on patients’ attitude to an exercise intervention following recovery from critical illness, and provides insight into the potential facilitators and barriers to delivery of the program and how programs should be evolved for future trials.

scholarly journals A 12-Words-for-Life-Nurturing Exercise Program as an Alternative Therapy for Cervical Spondylosis: A Randomized Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-7
Author(s):  
Zhijun Hu ◽  
Zhanying Tang ◽  
Shiwei Wang ◽  
Xiulan Ye ◽  
Yongjun Wang ◽  
...  
Keyword(s):  
Cervical Spondylosis ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Alternative Therapy ◽  
Exercise Program ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Sf 36 ◽  
The Mean

In this paper, we carried out a randomized controlled clinical trial to explore the effect of 12-words-for-life-nurturing exercise on patients presenting with cervical spondylosis. After exercise intervention, the mean VAS and NDI scores of the patients decreased significantly and the scores of BP, VT, and MH in SF-36 Health Questionnaire were significantly higher. Exercise therapy showed significant effect on relieving pain and improving vitality and mental health. The 12-words-for-life-nurturing exercise may be a potential effective therapy for patients with cervical spondylosis.

scholarly journals A randomised controlled trial of energetic activity for depression in young people (READY): a multi-site feasibility trial protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
N. Howlett ◽  
L. Bottoms ◽  
A. Chater ◽  
A. B. Clark ◽  
T. Clarke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Large Scale ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Exercise Session ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Prevalence of depression is increasing in young people, and there is a need to develop and evaluate behavioural interventions which may provide benefits equal to or greater than talking therapies or pharmacological alternatives. Exercise could be beneficial for young people living with depression, but robust, large-scale trials of effectiveness and the impact of exercise intensity are lacking. This study aims to test whether a randomised controlled trial (RCT) of an intervention targeting young people living with depression is feasible by determining whether it is possible to recruit and retain young people, develop and deliver the intervention as planned, and evaluate training and delivery. Methods The design is a three-arm cluster randomised controlled feasibility trial with embedded process evaluation. Participants will be help-seeking young people, aged 13–17 years experiencing mild to moderate low mood or depression, referred from three counties in England. The intervention will be delivered by registered exercise professionals, supported by mental health support workers, twice a week for 12 weeks. The three arms will be high-intensity exercise, low-intensity exercise, and a social activity control. All arms will receive a ‘healthy living’ behaviour change session prior to each exercise session and the two exercise groups are energy matched. The outcomes are referral, recruitment, and retention rates; attendance at exercise sessions; adherence to and ability to reach intensity during exercise sessions; proportions of missing data; adverse events, all measured at baseline, 3, and 6 months; resource use; and reach and representativeness. Discussion UK National Health Service (NHS) policy is to provide young people with advice about using exercise to help depression but there is no evidence-based exercise intervention to either complement or as an alternative to medication or talking therapies. UK National Institute for Health and Care Excellence (NICE) guidelines suggest that exercise can be an effective treatment, but the evidence base is relatively weak. This feasibility trial will provide evidence about whether it is feasible to recruit and retain young people to a full RCT to assess the effectiveness and cost-effectiveness of an exercise intervention for depression. Trial registration ISRCTN, ISRCTN66452702. Registered 9 April 2020.

scholarly journals Pilot Study of Telehealth Delivered Rehabilitative Exercise for Youth With Concussion: The Mobile Subthreshold Exercise Program (MSTEP)

2021 ◽  
Vol 9 ◽  
Author(s):  
Sara P. D. Chrisman ◽  
Jason A. Mendoza ◽  
Chuan Zhou ◽  
Tonya M. Palermo ◽  
Tierra Gogue-Garcia ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rural Areas ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Exercise Program ◽  
Life Assessment ◽  
Fear Avoidance ◽  
Duration Of Symptoms ◽  
Persistent Symptoms

Background: Concussion is common, and up to 30% of youth develop persistent symptoms. Preliminary data suggests treatment with rehabilitative exercise is beneficial, but most programs require frequent in-person visits, which is challenging for youth in rural areas, and has been made more difficult for all youth during the COVID-19 pandemic. We have adapted an exercise intervention to be delivered via telehealth using Zoom and personal fitness devices, which could ensure access to this type of treatment.Objective: The goal of this study was to assess feasibility and acceptability of a telehealth delivered exercise intervention for concussion, the Mobile Subthreshold Exercise Program (MSTEP), and collect pilot data regarding efficacy.Materials and Methods: All youth received the 6-week MSTEP intervention which included wearing a Fitbit and setting exercise heartrate and duration goals weekly over Zoom with the research assistant. Youth completed standardized measures of concussive symptoms (Health Behavior Inventory, HBI), fear-avoidance (Fear of Pain Questionnaire, FOPQ) and health-related quality of life (Pediatric Quality of life Assessment, PedsQL), as well as a structured qualitative exit interview. We examined change in measures over time using mixed effects modeling, controlling for age, sex, prior concussion and duration of symptoms. We coded qualitative interviews using Thematic analysis.Results: We recruited 19 subjects, 79% female with average age 14.3 (SD 2.2) and mean duration of symptoms 75.6 days (SD 33.7). Participants wore the Fitbit on 80% of days, and completed 94% of surveys and 96% of Zoom calls. Concussive symptoms (HBI) decreased significantly over the 6 week intervention (−10.6, 95%CI: −16.0 to −5.1) as did fear-avoidance (−21.6, 95%CI: −29.8 to −13.5). PedsQL improved significantly during the same time period (+15.1, 95%CI: 8.6–21.6). Approximately three-quarters (76%) of youth rated their care as “excellent.” Participants appreciated the structure of the guided exercise program and the support of the RA. They also enjoyed being able to track their progress with the Fitbit.Conclusion: This study provides evidence for the feasibility and acceptability of a telehealth delivered rehabilitative exercise intervention for youth with concussion. Further research utilizing a randomized controlled trial is needed to assess efficacy.Clinical Trial Registration:https://clinicaltrials.gov, identifier: NCT03691363. https://clinicaltrials.gov/ct2/show/NCT03691363

scholarly journals A Supervised Exercise Intervention During Cancer Treatment for Adolescents and Young Adults - FiGHTING F!T: Study Protocol of a Randomised Controlled Trial.

2021 ◽  
Author(s):  
Claire Munsie ◽  
Jay Ebert ◽  
Joanne Collins ◽  
Megan Plaster ◽  
David Joske ◽  
...  
Keyword(s):  
Cancer Treatment ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Exercise Program ◽  
Adolescent And Young Adult ◽  
Trial Registry ◽  
Supervised Exercise ◽  
Wide Range ◽  
Patient Reported ◽  
Randomised Controlled

Abstract BackgroundHigh quality evidence supports the integration of exercise to mitigate treatment- related side effects in a wide range of paediatric and adult cancer cohorts. However, the implementation of exercise in adolescent and young adult (AYA) cancer patients is yet to be explored in depth. FiGHTINGF!T is a randomised controlled cross over trial designed to determine if a supervised, structured and progressive exercise program can reduce the decline in physical fitness (V02peak) associated with cancer treatment in AYAs from diagnosis. Methods/DesignA total of 40 AYAs recently diagnosed and due to commence systemic treatment (± 2 weeks) for a primary haematological malignancy or solid tumour will be recruited and randomised to either an immediate exercise intervention or usual care (delayed exercise) for 10 weeks. This randomised controlled crossover trial will see both groups engage in a supervised exercise intervention from either diagnosis (baseline assessment) for 10 weeks (0-10 weeks) or following an interim assessment to 20 weeks (10-20 weeks). The bi-weekly tailored exercise program will combine aerobic and resistance exercises and be supervised by an Accredited Exercise Physiologist. Participants will complete a range of assessments at 0, 10 and 20 weeks including cardiopulmonary exercise tests, 1 repetition maximum strength measures, physical functioning and self-reported quality of life measurements. Patient reported treatment-related toxicities will be recorded on a weekly basis. DiscussionThe FiGHTINGF!T trial will provide insight into the potential benefits of a supervised exercise program in AYAs undergoing cancer treatment. This trial will contribute to the evidence supporting the necessary integration of exercise during cancer treatment, specifically in the under-reported AYA cohort.Trial registrationThis trial was registered retrospectively with the Australia New Zealand Clinical Trial registry(ACTRN12620000663954;https://www.anzctr.org.au/ACTRN12620000663954.aspx). Trial registry date: 10th June 2020.

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