- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02159014
DanceFit Prime: A Dance Based Physical Activity and Nutritional Intervention for Primary Care - A Feasibility Study (DanceFit)
DanceFit Prime: A Dance Based Physical Activity and Nutritional Intervention to Reduce the Risk of Heart Disease, Stroke, Diabetes, and Dementia in Inactive Adults, in Primary Care Settings - A Feasibility Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Regular physical activity improves physical and mental health and reduces the risk of heart disease, stroke, cancer, diabetes, dementia, obesity and premature death from any cause (Department of Health & Prevention., 2004). Unfortunately the majority of adults are not active enough to reap these benefits (Chaudhury & Roth, 2006). Specific psychological techniques can be used to overcome the known barriers to increased activity. People who are inactive can be identified in primary care through the use of standard risk tools. Similarly, standard risk tools can identify people at high risk of stroke, heart disease and diabetes, and people at risk from dementia are identified by a diagnosis of mild cognitive impairment. Combining these clinical indicators can identify people who are inactive and at highest risk who may therefore benefit most from activity interventions. These high risk patients can be offered physical activity programmes that are designed to increase longterm adherence. Aerobic dance is an activity that combines physical, social and cognitive stimulation and allows easily adjusted intensity levels to meet individual needs. Engagement in an activity program also provides opportunities to offer advice on healthy nutrition and associated meal preparation skills. Information technology can be used to increase activity participation. Video materials can be produced to guide activity participation at home, thereby increasing overall activity participation.
TRIAL DESIGN The investigators plan a longitudinal study where participants will be followed up for a total of 24 weeks. Outcome measures will be collected at three time points that separates two phases. Phase 1 consists of the group based weekly intervention plus access to online material and Phase 2 consists of only access to the online material. The time points are: baseline (Time 0), 12 weeks post intervention (Time 1) and 24 weeks post intervention (Time 2). Outcomes measured at time 1 will be used to determine the effects of Phase 1 immediately following participation, and measure at 24 weeks (Time 2) to determine the outcomes 12 weeks after the end of the group based intervention intervention and therefore the longer term effects with support from online material only. Participants will therefore serve as their own controls during Phase 2 for comparison with Phase 1. In other words the investigators will compare the results for each participant following Phase 1 with their results following Phase 2 to determine the effects of removing the group facilitation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Essex
-
Chigwell, Essex, United Kingdom, IG6 2TA
- Chigwell Medical Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Male or female patients identified as Inactive/Moderately Inactive on the GPPAQ and at high risk due the presence of one or more of the following additional risk factors:
- 20% or higher 10 year risk of stroke or heart attack by using QRISK2 for stroke (Hippisley-Cox, Coupland, Vinogradova, et al, 2008).
- 20% or higher 10-year risk of type 2 diabetes on the QDS measure (Hippisley-Cox, Coupland, Robson, et al, 2009).
- Diagnosis of mild cognitive impairment from a memory clinic.
- Diagnosed transient ischaemic cardiac or cerebral event (stable ischaemic heart disease, transient ischaemic attack).
- Aged 17 years or older.
- At low risk from serious adverse effects from increased physical activity as indicated by performance on the revised Physical Activity Readiness Questionnaire (PAR-Q)(Thomas, Reading & Shephard, 1992).
- Participants should have a suitable exercise space available at home for safe participation in the online component.
- Participants with access to the internet at home, and where it has been determined following a home visit by the research team that they can access the online material and safely participate.
Exclusion Criteria:
- Blood pressure above 160/100 mmHg.
- Body mass index over 40 kg/m2.
- Musculoskeletal or other medical problems preventing safe participation in regular moderate intensity exercise (65-77% of predicted maximum heart rate). This will include a resting tachycardia (heart rate above 100 bpm) and history of myocardial infarction, unstable angina or transient cerebral ischemia within the last month, severe osteoporosis, uncontrolled diabetes, febrile illness and destabilising arrythmias.
- Participants with modifiable exclusion criteria will be reconsidered after successful management. Patients will be referred for medical /cardiological review and management prior to commencing exercise if indicated by the PAR-Q and the intervention will be guided by the PARmed-X (Chisholm, Stewart & Crooks, 1987).
- Participants taking medications affecting heart rate will need to be on a stable dosing regimen for 3 months prior to commencing in order to control for potential spurious results on fitness measures caused by these treatments.
- Participants who do not have the necessary space, internet connection or computer equipment to allow them to participate safely using the online material.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 1
Facilitated group-based physical activity (aerobic dance), online physical activity (video based aerobic dance) and nutritional intervention (nutritional education, cooking skill training, access and use of NHS Change4Life Eat Well web resource).
|
Physical activity facilitated by instructor
Supported online activity intervention
Education, skill training, access and use of NHS Change4Life Eat Well web resource
|
Active Comparator: Phase 2
Self-paced online physical activity (video based aerobic dance) intervention and use of NHS Change4Life Eat Well web resource.
|
Self paced physical activity
Individual use of online nutritional advice resources.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recruitment and retention rates
Time Frame: 24 weeks
|
24 weeks
|
Activity adherence rates
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of physical activity participation
Time Frame: 24 weeks
|
Assessed using the General Practice Physical Activity Questionnaire (GPPAQ)
|
24 weeks
|
10 year risk of cardiac or cerebral ischaemic event
Time Frame: 24 weeks
|
Assessed using the QRISK2 for CVD / Stroke
|
24 weeks
|
10 year risk of developing diabetes mellitus
Time Frame: 24 weeks
|
Assessed using the QDS Diabetes risk tool
|
24 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive and anxiety symptoms
Time Frame: 24 weeks
|
Assessed on the Hospital Anxiety and Depression Scale (HADS)
|
24 weeks
|
Change in cardiovascular fitness.
Time Frame: 24 weeks
|
Assessed on the Modified Siconolfi Step Test
|
24 weeks
|
Change in body composition
Time Frame: 24 weeks
|
Assessed by measuring body fat percentage
|
24 weeks
|
Life quality
Time Frame: 24 weeks
|
Assessed on the World Health Organization Quality of Life (WHOQOL-BREF) tool.
|
24 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Thomas M Dannhauser, PhD, North Essex Partnership Foundation NHS Trust, University College London
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DanceFit Prime
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
Clinical Trials on Facilitated group-based aerobic dance
-
Chinese University of Hong KongThe Hong Kong Polytechnic UniversityUnknown
-
University of HelsinkiFinnish Institute for Health and Welfare; Municipality of Sipoo, Health and... and other collaboratorsCompletedHealth Promotion | MultimorbidityFinland
-
Children's Hospital of Eastern OntarioThe Hospital for Sick Children; University of Ottawa; Université de MontréalUnknownPain | Juvenile Idiopathic ArthritisCanada
-
Istanbul University - Cerrahpasa (IUC)CompletedObesity | Exercise | Morbid Obesity | Bariatric Surgery CandidateTurkey
-
University of Illinois at ChicagoNational Institute on Aging (NIA)Active, not recruitingMild Cognitive Impairment | Older Adults | Neurological InjuryUnited States
-
University of Illinois at ChicagoSuspendedStrokeUnited States
-
Drexel UniversityStony Brook University; National Center for Complementary and Integrative Health...UnknownChronic Low-back PainUnited States
-
Chulalongkorn UniversityCompletedDiabetic Neuropathies | Exercise AddictionThailand
-
University of AlbertaRecruiting
-
Federal University of PelotasUnknown