scholarly journals HALT (Hernia Active Living Trial): protocol for a feasibility study of a randomised controlled trial of a physical activity intervention to improve quality of life in people with bowel stoma with a bulge/parastomal hernia

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Gill Hubbard ◽  
Rebecca J. Beeken ◽  
Claire Taylor ◽  
Raymond Oliphant ◽  
Angus J. M. Watson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Body Image ◽  
Randomised Controlled Trial ◽  
Feasibility Study ◽  
Parastomal Hernia ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Randomised Controlled

Abstract Background Parastomal hernia (PSH) can be repaired surgically, but results to date have been disappointing, with reported recurrence rates of 30 to 76%. Other types of intervention are therefore needed to improve the quality of life of people with PSH. One potential intervention is physical activity. We hypothesise that the intervention will increase core activation and control across the abdominal wall at a site of potential weakness and thus reduce the risk of PSH progression. Increases in physical activity will improve body image and quality of life (QoL). Methods Subjects and sample There were approximately 20 adults with a bowel stoma and PSH. People with previous PSH repair will be excluded as well as people who already do core training. Study design This is a feasibility study of a randomised controlled trial with 2 months follow-up, in 2 sites using mixed methods. Stage 1 involves intervention development and in stage 2, intervention and trial parameters will be assessed. Intervention A theoretically informed physical activity intervention was done, targeting people with PSH. Main outcome of feasibility study The main outcome is the decision by an independent Study Steering Committee whether to proceed to a full randomised controlled trial of the intervention. Other outcomes We will evaluate 4 intervention parameters—fidelity, adherence, acceptability and safety and 3 trial parameters (eligible patients’ consent rate, acceptability of study design and data availability rates for following endpoints): Diagnosis and classification of PSH Muscle activation Body composition (BMI, waist circumference) Patient reported outcomes: QoL, body image and physical functioning Physical activity; Psychological determinants of physical activity Other data Included are other data such as interviews with all participants about the intervention and trial procedures. Data analysis and statistical power As this is a feasibility study, the quantitative data will be analysed using descriptive statistics. Audio-recorded qualitative data from interviews will be transcribed verbatim and analysed thematically. Discussion The feasibility and acceptability of key intervention and trial parameters will be used to decide whether to proceed to a full trial of the intervention, which aims to improve body image, quality of life and PSH progression. Trial registration ISRCTN15207595

The impact of physical activity on fatigue and quality of life in lung cancer patients: A randomised controlled trial (RCT).

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. 9507-9507 ◽  
Author(s):  
Janette L. Vardy ◽  
Melanie Bell ◽  
Hidde van der Ploeg ◽  
Jane Turner ◽  
Michael Kabourakis ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Lung Cancer ◽  
Randomised Controlled Trial ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Lung Cancer Patients ◽  
Randomised Controlled ◽  
The Impact

scholarly journals Individualised behaviour change strategies for physical activity in multiple sclerosis (IPAC-MS): protocol for a randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Farren L. Goulding ◽  
Charity D. Evans ◽  
Katherine B. Knox ◽  
Hyun J. Lim ◽  
Michael C. Levin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Multiple Sclerosis ◽  
Randomised Controlled Trial ◽  
Behaviour Change ◽  
Controlled Trial ◽  
Activity Level ◽  
Change Strategies ◽  
Randomised Controlled

Abstract Background Multiple sclerosis (MS) is a chronic, degenerative disease of the central nervous system. Because of the long-term and unpredictable nature of the disease, the burden of MS is significant from both a patient and societal perspective. Despite a recent influx of disease-modifying therapies to treat MS, many individuals continue to experience disability that negatively affects productivity and quality of life. Previous research indicates that physical activity has a positive impact on walking function in individuals with MS, in addition to the usual beneficial effects on overall health. However, most people with MS are not active enough to gain these benefits, and a lack of support to initiate and maintain physical activity has been identified as a major barrier. This study will evaluate the impact of a novel intervention involving individualised behaviour change strategies delivered by neurophysiotherapists on increasing physical activity levels in individuals with MS who are currently inactive. Methods/design This single-blind, parallel-group, randomised controlled trial will be conducted in Saskatchewan, Canada. Eligible participants include individuals with MS who are ambulatory but identified as currently inactive by the self-reported Godin Leisure-Time Exercise Questionnaire (GLTEQ). The intervention will be delivered by neurophysiotherapists and includes individualised behaviour change strategies aimed at increasing physical activity over a 12-month period. The control group will receive usual care during the 12-month study period. The primary outcome is the change in physical activity level, as measured by the change in the GLTEQ score from baseline to 12 months. Secondary outcomes include the change in patient-reported outcome measures assessing MS-specific symptoms, confidence and quality of life. Discussion Physical activity has been identified as a top research priority by the MS community. Findings from this novel study may result in new knowledge that could significantly impact the management and overall health of individuals with MS. Trial registration ClinicalTrials.gov, NCT04027114. Registered on 10 July 2019.

scholarly journals Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024862 ◽  
Author(s):  
Adele Krusche ◽  
Katherine Bradbury ◽  
Teresa Corbett ◽  
Jane Barnett ◽  
Beth Stuart ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Well Being ◽  
Improve Quality ◽  
Randomised Controlled ◽  
Human Support

IntroductionLow quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management.Methods and analysisA randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support.Ethics and disseminationThe trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations.Trial registration numberISRCTN96374224; Pre-results.

A Randomised Controlled Trial of a Digital Therapy for Diabetes Prevention Among High Risk Individual: Study Protocol (the Mydipp Trial)

2020 ◽  
Author(s):  
Nurul Fatihah Mohd Fauzi ◽  
Sharifah Wajihah Wafa ◽  
Naresh Bhaskar Raj ◽  
Mohd Ibrahim Abdullah ◽  
Barakatun Nisak Mohd Yusof ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Type 2 Diabetes ◽  
Randomised Controlled Trial ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Parallel Group ◽  
Randomised Controlled

Abstract Background: Approximately 37% of the individuals with prediabetes will have diabetes in four years if they do not change their lifestyle through any intervention. Lifestyle modification intervention has shown to be effective in reducing or delaying the onset of type 2 diabetes mellitus (T2DM) among high-risk individuals. Some intervention approaches integrate human coaching into technology using phone or email to enable wider reach, known as digital therapy. It is considered as a scalable method to reach a larger population who are at risk, convenient and accessible. This study aims to determine the feasibility and efficacy of lifestyle intervention to prevent type 2 diabetes among adults who are at risk of developing diabetes, an assessor-blinded, parallel-group, randomised controlled trial using the Malaysia Diabetes Prevention Programme (MyDiPP) app.Methods: ‘MyDiPP’ is a 12-month lifestyle intervention digital therapy with multiple approaches (weight loss, dietary modification, physical activity and quality of life). Eligible adults are aged 18-65 years, overweight/obese (BMI ≥ 23 kgm2) and athigh-risk for type2diabetes (American Diabetes Association(ADA) Diabetes Risk Score ≥ 5, or HbA1c of 5.6-6.2%). Each participant will be randomly assigned to one oftwo study groups in 1:1 ratio using simple randomisation to intervention or usual care control groups. The primary outcome is the change in weight at 6 months and 12 months, while the secondary outcomes are changes in HbA1c level, physical activity level, dietary intake and quality of life. The MyDiPP programme is an assessor-blinded, parallel-group, randomised controlled trial, in which the app consists of educational lessons, group, technology-enabled discussions, tools to track nutritional intake, physical activity, body weight and blood glucose level as well as platform to communicate with the health coaches. Discussion: This study is necessary to determine to what extent the intervention programme reduces risks of diabetes risk in comparison to the usual care.Trial registration details:This trial was prospectively registered with Clinical Trial Registry (CTR) on 21st June 2019 with trial registration number NCT03997656.

scholarly journals The impact of physical activity on fatigue and quality of life in lung cancer patients: a randomised controlled trial protocol

BMC Cancer ◽  
2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Haryana M Dhillon ◽  
Hidde P van der Ploeg ◽  
Melanie L Bell ◽  
Michael Boyer ◽  
Stephen Clarke ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Lung Cancer ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Trial Protocol ◽  
Lung Cancer Patients ◽  
Randomised Controlled ◽  
The Impact

scholarly journals Associations between quality of life and duration and frequency of physical activity and sedentary behaviour: Baseline findings from the WALK 2.0 randomised controlled trial

PLoS ONE ◽  
2017 ◽  
Vol 12 (6) ◽  
pp. e0180072 ◽  
Author(s):  
Gregory S. Kolt ◽  
Emma S. George ◽  
Amanda L. Rebar ◽  
Mitch J. Duncan ◽  
Corneel Vandelanotte ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Sedentary Behaviour ◽  
Controlled Trial ◽  
Randomised Controlled
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