NCT02159014

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

June 3, 2014

Last Update Submit

October 13, 2015

Conditions

Cardiac DiseasesStrokeDiabetes MellitusDementiaMild Cognitive Impairment

Keywords

Physical activity interventionAerobic danceNutritional interventionOnline participationPrimary Care settingsGeneral Practice Physical Activity Questionnaire GPPAQQrisk2QDS Diabetes

Outcome Measures

Primary Outcomes (2)

  • Recruitment and retention rates

    24 weeks

  • Activity adherence rates

    24 weeks

Secondary Outcomes (3)

  • Level of physical activity participation

    24 weeks

  • 10 year risk of cardiac or cerebral ischaemic event

    24 weeks

  • 10 year risk of developing diabetes mellitus

    24 weeks

Other Outcomes (4)

  • Depressive and anxiety symptoms

    24 weeks

  • Change in cardiovascular fitness.

    24 weeks

  • Change in body composition

    24 weeks

  • +1 more other outcomes

Study Arms (2)

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).

Behavioral: Facilitated group-based aerobic danceBehavioral: Online, video prompted, individual aerobic danceBehavioral: 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.

Behavioral: Self-paced online aerobic dance activityBehavioral: Individual self-paced nutritional intervention

Interventions

Facilitated group-based aerobic danceBEHAVIORAL

Physical activity facilitated by instructor

Phase 1
Online, video prompted, individual aerobic danceBEHAVIORAL

Supported online activity intervention

Phase 1
Facilitated group-based nutritional interventionBEHAVIORAL

Education, skill training, access and use of NHS Change4Life Eat Well web resource

Phase 1
Self-paced online aerobic dance activityBEHAVIORAL

Self paced physical activity

Phase 2
Individual self-paced nutritional interventionBEHAVIORAL

Individual use of online nutritional advice resources.

Phase 2

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • % or higher 10 year risk of stroke or heart attack by using QRISK2 for stroke (Hippisley-Cox, Coupland, Vinogradova, et al, 2008).
  • % 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.

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chigwell Medical Centre

Chigwell, Essex, IG6 2TA, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24886353BACKGROUND

MeSH Terms

Conditions

Heart DiseasesStrokeDiabetes MellitusDementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Thomas M Dannhauser, PhD

    North Essex Partnership Foundation NHS Trust, University College London

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 9, 2014

Study Start

August 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

GB(1)