A multicomponent integrative intervention to slow down the progression of mild cognitive impairment: A protocol for a randomized controlled trial

Mild cognitive impairment affects 36% of people aged 65 years and over in China, and around 50% transition from mild cognitive impairment to dementia within 3 years. Early intervention can slow down disease progression and thus delay dementia onset. The purpose of this article is to outline the protocol of an ongoing randomized controlled trial in mainland China that will evaluate the effects and feasibility of a 6-month multicomponent integrative intervention on the speed of progression of mild cognitive impairment to dementia. Ninety-six community-dwelling older adults, aged 65 years and older, will be recruited (recruitment will be completed in May 2020), using strict inclusion/exclusion criteria, from two community health service centers in Guangzhou, Guangdong province. Participants will be allocated to receive either the multicomponent integrative intervention or usual care. The core components of the intervention are cognitive training, dietary instruction, physical activity, and management of vascular risk factors. Data are collected at the beginning of the study, then at 1, 3, and 6 months. The primary outcome is cognitive function. The main secondary outcomes are exercise capacity, comprehensive physical capacity, depression, and quality of life. An intention-to-treat analysis will be conducted. The study will be completed in 2021. The multicomponent integrative intervention detailed in this protocol could be incorporated into dementia prevention programs in community health service centers, or other similar settings, to delay the onset of dementia.     

Barriers to implementing cardiovascular risk tables in routine general practice

Design Qualitative study. GPs were interviewed after analysing two audiotaped cardiovascular consultations.

Setting Primary health care.

Subjects A sample of 15 GPs who audiotaped 22 consultations.

Main outcome measures Barriers hampering GPs from following the guideline.

Results Data saturation was reached after about 13 interviews. The 25 identified barriers were related to the risk table, the GP or to environmental factors. Lack of knowledge and poor communication skills of the GP, along with pressure of work and demanding patients, cause GPs to deviate from the guideline. GPs regard barriers external to themselves as most important.

Conclusion Using the risk table as a key element of the high-risk approach in primary prevention encounters many barriers. Merely incorporating risk tables in guidelines is not sufficient for implementation of the guidelines. Time-efficient implementation strategies dealing in particular with the communication and presentation of cardiovascular risk are needed.     

Exercise intervention and health checks for middle-aged men with elevated cardiovascular risk: A randomized controlled trial

Abstract

Objective. To study the effects of a health check by a nurse alone or combined with an exercise intervention in middle-aged men at increased cardiovascular risk. Design. A randomized controlled trial. Setting and intervention. Primary care in Kirkkonummi municipality with 36 000 inhabitants. A health check by a nurse alone or combined with an exercise intervention to controls with no intervention was compared. Subjects. A total of 168 men aged 35 to 45 years with at least two cardiovascular risk factors and physical activity (PA) frequency < 3 times a week. Main outcome measures. Metabolic syndrome (MetS) as defined by International Diabetes Federation/American Heart Association and self-reported PA frequency. Results. Overall, focusing on health increased physical activity frequency in middle-aged men. After one year, 19% had increased PA to ≥ 3 times a week (95% CI 12–26). All study groups increased PA to ≥ 3 times: 26% of men in the exercise intervention group, 15% of men in the health check group, and 16% of controls. The differences between the groups were not statistically significant. The intervention did not have any meaningful impact on MetS or other cardiovascular outcomes at one-year follow up. Conclusions. Physical activity increased in all study groups of middle-aged men in this health-promotion trial. The interventions had no effect on metabolic syndrome or other cardiovascular outcomes in the participants. The trial increased awareness and collaboration in physical activity promotion among municipal health care and exercise services.     

Music in mind, a randomized controlled trial of music therapy for young people with behavioural and emotional problems: study protocol

porter s., holmes v., mclaughlin k., lynn f., cardwell c., braiden h.-j., doran j. & rogan s. (2012)?Music in mind, a randomized controlled trial of music therapy for young people with behavioural and emotional problems: study protocol. Journal of Advanced Nursing68(10), 2349-2358. ABSTRACT: Aims. This article is a report of a trial protocol to determine if improvizational music therapy leads to clinically significant improvement in communication and interaction skills for young people experiencing social, emotional or behavioural problems. Background. Music therapy is often considered an effective intervention for young people experiencing social, emotional or behavioural difficulties. However, this assumption lacks empirical evidence. Study design. Music in mind is a multi-centred single-blind randomized controlled trial involving 200 young people (aged 8-16?years) and their parents. Eligible participants will have a working diagnosis within the ambit of International Classification of Disease 10 Mental and Behavioural Disorders and will be recruited over 15?months from six centres within the Child and Adolescent Mental Health Services of a large health and social care trust in Northern Ireland. Participants will be randomly allocated in a 1:1 ratio to receive standard care alone or standard care plus 12 weekly music therapy sessions delivered by the Northern Ireland Music Therapy Trust. Baseline data will be collected from young people and their parents using standardized outcome measures for communicative and interaction skills (primary endpoint), self-esteem, social functioning, depression and family functioning. Follow-up data will be collected 1 and 13?weeks after the final music therapy session. A cost-effectiveness analysis will also be carried out. Discussion. This study will be the largest trial to date examining the effect of music therapy on young people experiencing social, emotional or behavioural difficulties and will provide empirical evidence for the use of music therapy among this population. Trial registration. This study is registered in the ISRCTN Register, ISRCTN96352204. Ethical approval was gained in October 2010.     

Pilates for low risk pregnant women: Study protocol for a randomized controlled trial

BackgroundPilates has growing appeal to pregnant women, as a form of exercise and relaxation. It is purported to benefit lumbo-pelvic stability, as well as motor control, strength and endurance. Some suggest that modified Pilates exercises may assist low risk pregnant women to enjoy a healthier pregnancy and prepare for the physical demands of labour and birth. The feasibility and safety of Pilates during pregnancy is poorly understood. We describe the protocol for a feasibility study designed to compare a midwife-led 6-week community-based Pilates intervention with standard antenatal care.MethodsA convenience sample of 30 low-risk pregnant women will be recruited from private obstetric clinics in Melbourne, Australia. Participants shall be randomly allocated to a six-week, 1-h weekly Pilates exercises group session or to usual care. The Pilates exercise class will have a warm-up phase, Pilates exercises, breathing exercises, and a cool down phase. Exercises have been designed to prepare for active birth. The primary outcome will be feasibility of implementation, determined by recruitment, retention, adherence and safety. Secondary outcomes include women's health (quality of life, pain, mobility for daily activities, lower extremity performance, abdominal separation, continence) and labour and birth outcomes (duration of first stage and second stage labour, analgesia used, mode of birth). Validated questionnaires will include the Quality of life 12-item short form survey; Pregnancy Mobility Index, and International Consultation on Incontinence Questionnaire. Lower extremity performance and abdominal separation will also be measured.DiscussionThis trial will provide preliminary data regarding the feasibility and safety of Pilates exercise in healthy pregnant women. It will also provide preliminary outcome data used to inform the design of a future large scale, multi-centre RCT.Trial registrationThis clinical trial has been registered with the Australian and New Zealand Clinical Trials Registry 2016 (ACTRN12616000809437).