Cardiac DiseasesDanceFitNCT02159014
DanceFit Prime: A Dance Based Physical Activity and Nutritional Intervention for Primary Care - A Feasibility Study
A study testing Facilitated group-based aerobic dance, Online, video prompted, individual aerobic dance and Facilitated group-based nutritional intervention in people with Cardiac Diseases and Stroke, run by North Essex Partnership NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Regular physical activity improves physical and mental health and reduces the risk of heart disease, stroke, cancer, diabetes, obesity and premature death from any cause. Unfortunately the majority of adults are not active enough to reap these benefits. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Cardiac Diseases, Stroke, Diabetes Mellitus
- What is being tested?
- Facilitated group-based aerobic dance, Online, video prompted, individual aerobic dance and Facilitated group-based nutritional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Regular physical activity improves physical and mental health and reduces the risk of heart disease, stroke, cancer, diabetes, obesity and premature death from any cause. Unfortunately the majority of adults are not active enough to reap these benefits. People who are inactive and at high risk of stroke, heart disease, diabetes and dementia, and who may benefit from increased activity can be identified in primary care by combining standard risk tools. 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. The investigators propose a feasibility study of a multimodal dance-based physical activity and nutrition intervention aimed at patients at high risk of stroke, heart disease, diabetes and dementia, in primary care settings.
Read the 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.
- Conditions
- Cardiac Diseases, Stroke, Diabetes Mellitus, Dementia, Mild Cognitive Impairment
- Being tested
- Facilitated group-based aerobic dance, Online, video prompted, individual aerobic dance, Facilitated group-based nutritional intervention, Self-paced online aerobic dance activity, Individual self-paced nutritional intervention
- Keywords
- Physical activity intervention, Aerobic dance, Nutritional intervention, Online participation, Primary Care settings, General Practice Physical Activity Questionnaire GPPAQ, Qrisk2, QDS Diabetes
- Medical subject headings
- Heart Diseases, Stroke, Diabetes Mellitus, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated group-based aerobic danceBehavioural
Physical activity facilitated by instructor
Online, video prompted, individual aerobic danceBehavioural
Supported online activity intervention
Facilitated group-based nutritional interventionBehavioural
Education, skill training, access and use of NHS Change4Life Eat Well web resource
Self-paced online aerobic dance activityBehavioural
Self paced physical activity
Individual self-paced nutritional interventionBehavioural
Individual use of online nutritional advice resources.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | 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). Receives: Behavioral: Facilitated group-based aerobic dance; Behavioral: Online, video prompted, individual aerobic dance; Behavioral: Facilitated group-based nutritional intervention |
| Phase 2 | Active comparator | Self-paced online physical activity (video based aerobic dance) intervention and use of NHS Change4Life Eat Well web resource. Receives: Behavioral: Self-paced online aerobic dance activity; Behavioral: Individual self-paced nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention rates
Measured: 24 weeks
Activity adherence rates
Measured: 24 weeks
Secondary outcomes (3)
Level of physical activity participation
Assessed using the General Practice Physical Activity Questionnaire (GPPAQ)
Measured: 24 weeks
10 year risk of cardiac or cerebral ischaemic event
Assessed using the QRISK2 for CVD / Stroke
Measured: 24 weeks
10 year risk of developing diabetes mellitus
Assessed using the QDS Diabetes risk tool
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Essex Partnership NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- West Essex Clinical Commissioning Group, School for Social Entrepreneurs London and Lloyds TSB, University College, London
- Responsible party
- Principal investigator, Dr Thomas Dannhauser, North Essex Partnership NHS Foundation Trust
- Investigators
- Thomas M Dannhauser, PhD, Study director, North Essex Partnership Foundation NHS Trust, University College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159014
- Sponsor's protocol ID
- DanceFit Prime
- Acronym
- DanceFit
- Status last verified
- Oct 2015
- First submitted
- 3 Jun 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dannhauser TM, Cleverley M, Whitfield TJ, Fletcher BC, Stevens T, Walker Z. A complex multimodal activity intervention to reduce the risk of dementia in mild cognitive impairment--ThinkingFit: pilot and feasibility study for a randomized controlled trial. BMC Psychiatry. 2014 May 5;14:129. doi: 10.1186/1471-244X-14-129.
PubMed 24886353
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02159014
- Acronym / sponsor ID
- DanceFit / DanceFit Prime
- Conditions
- Cardiac Diseases, Stroke, Diabetes Mellitus, Dementia, Mild Cognitive Impairment
- Keywords
- Physical activity intervention, Aerobic dance, Nutritional intervention, Online participation, Primary Care settings, General Practice Physical Activity Questionnaire GPPAQ, Qrisk2, QDS Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- North Essex Partnership NHS Foundation TrustOther government
- Collaborators
- West Essex Clinical Commissioning Group, School for Social Entrepreneurs London and Lloyds TSB, University College, London
- Study start
- Aug 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regular physical activity improves physical and mental health and reduces the risk of heart disease, stroke, cancer, diabetes, obesity and premature death from any cause. Unfortunately the majority of adults are not active enough to reap these benefits. People who are inactive and at high risk of stroke, heart disease, diabetes and dementia, and who may benefit from increased activity can be identified in primary care by combining standard risk tools. 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. The investigators propose a feasibility study of a multimodal dance-based physical activity and nutrition intervention aimed at patients at high risk of stroke, heart disease, diabetes and dementia, in primary care settings.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Behavioral: Facilitated group-based aerobic dance, Behavioral: Online, video prompted, individual aerobic dance, Behavioral: Facilitated group-based nutritional interventionFacilitated 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). |
| Phase 2 | Active comparator | Behavioral: Self-paced online aerobic dance activity, Behavioral: Individual self-paced nutritional interventionSelf-paced online physical activity (video based aerobic dance) intervention and use of NHS Change4Life Eat Well web resource. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitated group-based aerobic dancePhysical activity facilitated by instructor | Behavioural | Phase 1 |
| Online, video prompted, individual aerobic danceSupported online activity intervention | Behavioural | Phase 1 |
| Facilitated group-based nutritional interventionEducation, skill training, access and use of NHS Change4Life Eat Well web resource | Behavioural | Phase 1 |
| Self-paced online aerobic dance activitySelf paced physical activity | Behavioural | Phase 2 |
| Individual self-paced nutritional interventionIndividual use of online nutritional advice resources. | Behavioural | Phase 2 |
Primary outcome
Recruitment and retention rates
Time frame: 24 weeks
Activity adherence rates
Time frame: 24 weeks
3 secondary outcomes
Level of physical activity participation
Time frame: 24 weeks
10 year risk of cardiac or cerebral ischaemic event
Time frame: 24 weeks
10 year risk of developing diabetes mellitus
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 24886353Dannhauser TM, Cleverley M, Whitfield TJ, Fletcher BC, Stevens T, Walker Z. A complex multimodal activity intervention to reduce the risk of dementia in mild cognitive impairment--ThinkingFit: pilot and feasibility study for a randomized controlled trial. BMC Psychiatry. 2014 May 5;14:129. doi: 10.1186/1471-244X-14-129.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas M Dannhauser, PhD study director
North Essex Partnership Foundation NHS Trust, University College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated group-based aerobic dance, Online, video prompted, individual aerobic dance and Facilitated group-based nutritional intervention in people with Cardiac Diseases and Stroke, run by North Essex Partnership NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention rates (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02159014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.