scholarly journals Fit for purpose. Co-production of complex behavioural interventions. A practical guide and exemplar of co-producing a telehealth-delivered exercise intervention for people with stroke

2022 ◽  
Vol 20 (1) ◽  
Author(s):  
Emily R. Ramage ◽  
Meredith Burke ◽  
Margaret Galloway ◽  
Ian D. Graham ◽  
Heidi Janssen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Exercise Intervention ◽  
Complex Interventions ◽  
Exercise Program ◽  
Intervention Package ◽  
Production Team ◽  
Knowledge User ◽  
Intervention Protocol ◽  
Stage Process ◽  
Practical Guidance

Abstract Background Careful development of interventions using principles of co-production is now recognized as an important step for clinical trial development, but practical guidance on how to do this in practice is lacking. This paper aims (1) provide practical guidance for researchers to co-produce interventions ready for clinical trial by describing the 4-stage process we followed, the challenges experienced and practical tips for researchers wanting to co-produce an intervention for a clinical trial; (2) describe, as an exemplar, the development of our intervention package. Method We used an Integrated Knowledge Translation (IKT) approach to co-produce a telehealth-delivered exercise program for people with stroke. The 4-stage process comprised of (1) a start-up planning phase with the co-production team. (2) Content development with knowledge user informants. (3) Design of an intervention protocol. (4) Protocol refinement. Results and reflections The four stages of intervention development involved an 11-member co-production team and 32 knowledge user informants. Challenges faced included balancing conflicting demands of different knowledge user informant groups, achieving shared power and collaborative decision making, and optimising knowledge user input. Components incorporated into the telehealth-delivered exercise program through working with knowledge user informants included: increased training for intervention therapists; increased options to tailor the intervention to participant’s needs and preferences; and re-naming of the program. Key practical tips include ways to minimise the power differential between researchers and consumers, and ensure adequate preparation of the co-production team. Conclusion Careful planning and a structured process can facilitate co-production of complex interventions ready for clinical trial. Graphical Abstract

Randomized clinical trial on the effect of a supervised exercise program on quality of life, fatigue, and fitness following esophageal cancer treatment (PERFECT study).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12055-12055
Author(s):  
Anne Maria May ◽  
Jonna van Vulpen ◽  
Anouk E Hiensch ◽  
Jelle P. Ruurda ◽  
Grard Nieuwenhuijzen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Esophageal Cancer ◽  
Cardiorespiratory Fitness ◽  
Exercise Intervention ◽  
Exercise Program ◽  
Post Intervention ◽  
Supervised Exercise ◽  
Supervised Exercise Program

12055 Background: Patients with potentially curable esophageal cancer are often treated with chemoradiotherapy followed by surgery. This treatment might have a negative impact on physical fitness, fatigue and quality of life (QoL). In patients with other types of cancer, evidence suggests that physical exercise reduces treatment related side effects. We investigated whether a supervised exercise program also beneficially affects QoL, fatigue and cardiorespiratory fitness (CRF) in patients after treatment for esophageal cancer. Methods: The multicenter PERFECT study randomly assigned patients in the first year after esophagectomy to an exercise intervention (EX) or usual care (UC) group. EX patients participated in a 12-week moderate to high intensity aerobic and resistance exercise program supervised by a physiotherapist. UC patients were advised to maintain their physical activity levels. Attendance and compliance with the exercise intervention protocol were retrieved from exercise logs. QoL (primary outcome, EORTC-QLQ-30, range 0-100), fatigue (MFI-20, range 4-20) and CRF (cardiopulmonary exercise testing) were assessed at baseline and after 12 weeks (post-intervention). The outcomes were analyzed as between-group differences using either linear mixed effects models or ANCOVA adjusted for baseline and stratification factors (i.e. sex, time since surgery, center), according to the intention-to-treat principle. Results: A total of 120 patients (age 64±8) were included and randomized to EX (n = 61) or UC (n = 59). Patients in the EX group participated in 96% (IQR:92-100%) of the supervised exercise sessions and compliance with all parts of the exercise program was high ( > 90%). Post-intervention, global QoL was not statistically different between groups, but significant (p < 0.05) beneficial EX effects were found for QoL-Summary scores (between-group difference 3.5, 95% CI 0.2;6.8) and QoL-role functioning (9.4, 1.3;17.5). Physical fatigue wat non-significantly lower in the EX group (-1.2; -2.6;0.1, p = 0.08). CRF was significantly higher (VO2peak (1.8 mL/min/kg, 0.6;3.0) following the EX intervention. Conclusions: Patients were well capable to complete an intensive supervised exercise program after esophageal cancer treatment, which led to small but significant improvements in several aspects of QoL and cardiorespiratory fitness. Our results suggest that supervised exercise is a beneficial addition to routine care of patients with esophageal cancer. Clinical trial information: NTR5045 .

scholarly journals The Effect of Aerobic Exercise on Concussion Recovery: A Pilot Clinical Trial

2021 ◽  
Vol 27 (8) ◽  
pp. 790-804 ◽  
Author(s):  
Aliyah R. Snyder ◽  
Sarah M. Greif ◽  
James R. Clugston ◽  
David B. FitzGerald ◽  
Joshua F. Yarrow ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Aerobic Exercise ◽  
Mixed Model ◽  
Exercise Intervention ◽  
Reference Group ◽  
Exercise Program ◽  
Neurocognitive Performance ◽  
Post Injury ◽  
Post Intervention ◽  
Severity Scores

AbstractObjective:The purpose of this study was to pilot safety and tolerability of a 1-week aerobic exercise program during the post-acute phase of concussion (14–25 days post-injury) by examining adherence, symptom response, and key functional outcomes (e.g., cognition, mood, sleep, postural stability, and neurocognitive performance) in young adults.Method:A randomized, non-blinded pilot clinical trial was performed to compare the effects of aerobic versus non-aerobic exercise (placebo) in concussion patients. The study enrolled three groups: 1) patients with concussion/mild traumatic brain injury (mTBI) randomized to an aerobic exercise intervention performed daily for 1-week, 2) patients with concussion/mTBI randomized to a non-aerobic (stretching and calisthenics) exercise program performed daily for 1-week, and 3) non-injured, no intervention reference group.Results:Mixed-model analysis of variance results indicated a significant decrease in symptom severity scores from pre- to post-intervention (mean difference = −7.44, 95% CI [−12.37, −2.20]) for both concussion groups. However, the pre- to post-change was not different between groups. Secondary outcomes all showed improvements by post-intervention, but no differences in trajectory between the groups. By three months post-injury, all outcomes in the concussion groups were within ranges of the non-injured reference group.Conclusions:Results from this study indicate that the feasibility and tolerability of administering aerobic exercise via stationary cycling in the post-acute time frame following post-concussion (14–25 days) period are tentatively favorable. Aerobic exercise does not appear to negatively impact recovery trajectories of neurobehavioral outcomes; however, tolerability may be poorer for patients with high symptom burden.

scholarly journals Move to health-a holistic approach to the management of chronic low back pain: an intervention and implementation protocol developed for a pragmatic clinical trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Daniel I. Rhon ◽  
Julie M. Fritz ◽  
Tina A. Greenlee ◽  
Katie E. Dry ◽  
Rachel J. Mayhew ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chronic Pain ◽  
Low Back Pain ◽  
Back Pain ◽  
Clinical Practice ◽  
Chronic Low Back Pain ◽  
Complex Interventions ◽  
Low Back ◽  
Health Coach ◽  
Intervention Protocol

Abstract Background The prevalence of chronic pain conditions is growing. Low back pain was the primary cause of disability worldwide out of 156 conditions assessed between 1990 and 2016, according to the Global Burden of Disease Study. Conventional medical approaches have failed to identify effective and long-lasting approaches for the management of chronic pain, and often fail to consider the multiple domains that influence overall health and can contribute to the pain experience. Leading international organizations that focus on pain research have stated the importance of considering these other domains within holistic and multidisciplinary frameworks for treating pain. While the research behind the theoretical link between these domains and chronic pain outcomes has expanded greatly over the last decade, there have been few practical and feasible methods to implement this type of care in normal clinical practice. Methods The purpose of this manuscript is to describe an implementation protocol that is being used to deliver a complex holistic health intervention at multiple sites within a large government health system, as part of a larger multisite trial for patients with chronic low back pain. The Move to Health program developed by the US Army Medical Command was tailored for specific application to patients with low back pain and begins by providing an empirical link between eight different health domains (that include physical, emotional, social, and psychological constructs) and chronic low back pain. Through a six-step process, a health coach leverages motivational interviewing and information from a personal health inventory to guide the patient through a series of conversations about behavioral lifestyle choices. The patient chooses which domains they want to prioritize, and the health coach helps implement the plan with the use of SMART (Specific, Measurable, Attainable, Realistic, Time-bound) goals and a series of resources for every domain, triaged from self-management to specialist referral. Discussion Complex interventions described in clinical trials are often challenging to implement because they lack sufficient details. Implementation protocols can improve the ability to properly deliver trial interventions into regular clinical practice with increased fidelity. Trial registration Implementation of this intervention protocol was developed for a clinical trial that was registered a priori (clinicaltrials.gov #NCT04172038).

scholarly journals Building the Rationale and Structure for a Complex Physical Therapy Intervention Within the Context of a Clinical Trial: A Multimodal Individualized Treatment for Patients With Hip Osteoarthritis

2011 ◽  
Vol 91 (10) ◽  
pp. 1525-1541 ◽  
Author(s):  
Kim L. Bennell ◽  
Thorlene Egerton ◽  
Yong-Hao Pua ◽  
J. Haxby Abbott ◽  
Kevin Sims ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Real World ◽  
Complex Interventions ◽  
Hip Osteoarthritis ◽  
Individualized Treatment ◽  
Treatment Modalities ◽  
Treatment Technique ◽  
Radiographic Findings ◽  
Intervention Protocol

Evaluating the efficacy of complex interventions such as multimodal, impairment-based physical therapy treatments in randomized controlled trials is essential to inform practice and compare relative benefits of available treatment options. Studies of physical therapy interventions using highly standardized intervention protocols, although methodologically rigorous, do not necessarily reflect “real-world” clinical practice, and in many cases results have been disappointing. Development of a complex intervention that includes multiple treatment modalities and individualized treatment technique selection requires a systematic approach to designing all aspects of the intervention based on theory, evidence, and practical constraints. This perspective article outlines the development of the rationale and structure of a multimodal physical therapy program for painful hip osteoarthritis to be assessed in a clinical trial. The resulting intervention protocol comprises a semi-structured program of exercises and manual therapy, advice, physical activity, and optional prescription of a gait aid that is standardized, yet can be individualized according to physical assessment and radiographic findings. The program is evidence based and reflects contemporary physical therapist practice, while also being reproducible and reportable. This perspective article aims to encourage physical therapy researchers involved in evaluation of complex interventions to better document their own intervention development, as well as the outcomes, thus generating a body of knowledge about the development processes and protocols that is generalizable to the real-world complexity of providing physical therapy to individual patients.

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 Effect of Baduanjin exercise intervention on cognitive function and quality of life in women with breast cancer receiving chemotherapy: study protocol of a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiao-Lin Wei ◽  
Ru-Zhen Yuan ◽  
Yong-Mei Jin ◽  
Shu Li ◽  
Ming-Yue Wang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Cognitive Function ◽  
Exercise Intervention ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Pharmacological Intervention ◽  
Control Group

Abstract Background More than 50% cognitive impairment was reported by cancer patients before and after medical treatment. However, there are no effective interventions to manage the cognitive problem in women with breast cancer. This pilot study was designed to evaluate the protective effect of Baduanjin exercise on cognitive function and cancer-related symptoms in women with early-stage breast cancer undergoing chemotherapy. Method A single-blinded, randomized control trial was designed. The trial will recruit 70 patients with early-stage breast cancer scheduled to receive chemotherapy from Shanghai in China. All participants will be randomly assigned to (1:1) the supervised Baduanjin group (5 times/week, 30 min each time) or the wait-list control group for 3 months. The effect of Baduanjin exercise intervention will be evaluated by outcome measures including subjective and objective cognitive function, symptoms (fatigue, depression, and anxiety), and health-related quality of life at pre-intervention (T0), 8 weeks (T1), and 12 weeks (T2). The PCI score in the FACT-Cog as the primary cognitive outcome will be reported descriptively, while effect sizes and 95% confidence intervals (CIs) will be calculated. The collected data will be analyzed by using an intention-to-treat principle and linear mixed-effects modeling. Discussion This is the first randomized clinical trial to investigate whether Baduanjin exercise will have a positive role in improving cognitive function in women with breast cancer receiving chemotherapy. If possible, Baduanjin exercise will be a potential non-pharmacological intervention to manage cognitive dysfunction and promote survivorship care among breast cancer survivors. Trial registration Chinese Clinical Trial Registry (ChiCTR) ChiCTR2000033152. Registered on 22 May 2020

scholarly journals The Effect of Structured Exercise on Sleep During the Corresponding Night Among Older Women in an Exercise Program

2019 ◽  
Vol 27 (4) ◽  
pp. 482-488
Author(s):  
Charity B. Breneman ◽  
Christopher E. Kline ◽  
Delia West ◽  
Xuemei Sui ◽  
Xuewen Wang
Keyword(s):  
Exercise Training ◽  
Sleep Quality ◽  
Older Women ◽  
Exercise Intervention ◽  
Multilevel Models ◽  
Exercise Program ◽  
Acute Effect ◽  
Treadmill Walking ◽  
Acute Bout ◽  
Sleep Parameters

This study investigated the acute effect of exercise on sleep outcomes among healthy older women by comparing days with structured exercise versus days without structured exercise during 4 months of exercise training. Participants (n = 51) in this study had wrist-worn actigraphic sleep data available following at least 3 days with structured exercise and 3 days without structured exercise at mid-intervention and at the end of intervention. The exercise intervention was treadmill walking. Multilevel models were used to examine whether structured exercise impacted sleep outcomes during the corresponding night. Overall, 1,362 nights of data were included in the analyses. In unadjusted and adjusted models, bedtimes were significantly earlier on evenings following an acute bout of structured exercise than on evenings without structured exercise. No other sleep parameters differed between exercise and nonexercise days. Understanding the effects of exercise on sleep in this understudied population may help to improve their overall sleep quality.

scholarly journals Delivering an In-Home Exercise Program via Telerehabilitation: A Pilot Study of Lung Transplant Go (LTGO)

2016 ◽  
Vol 8 (2) ◽  
pp. 15-26 ◽  
Author(s):  
JiYeon Choi ◽  
Andrea L. Hergenroeder ◽  
Lora Burke ◽  
Annette DeVito Dabbs ◽  
Matthew Morrell ◽  
...  
Keyword(s):  
Physical Activity ◽  
Physical Function ◽  
Lung Transplant ◽  
Exercise Intervention ◽  
Exercise Program ◽  
Integrated System ◽  
Home Exercise ◽  
Transplant Recipients ◽  
Walk Distance ◽  
Lung Transplant Recipients

We evaluated the feasibility, safety, system usability, and intervention acceptability of Lung Transplant Go (LTGO), an 8-week in-home exercise intervention for lung transplant recipients using a telerehabilitation platform, and described changes in physical function and physical activity from baseline to post-intervention. The intervention was delivered to lung transplant recipients in their home via the Versatile and Integrated System for TeleRehabilitation (VISYTER). The intervention focused on aerobic and strengthening exercises tailored to baseline physical function. Participants improved walk distance (6-minute walk distance), balance (Berg Balance Scale), lower body strength (30-second chair stand test) and steps walked (SenseWear Armband®). No adverse events were reported. Participants rated the program highly positively in regard to the technology and intervention. The telerehabilitation exercise program was feasible, safe, and acceptable. Our findings provide preliminary support for the LTGO intervention to improve physical function and promote physical activity in lung transplant recipients. 

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