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Light Intensity Physical Activity Trial (LiPAT)

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ClinicalTrials.gov Identifier: NCT03415880
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
European Foundation for the Study of Diabetes
Information provided by (Responsible Party):
C.D.A. Stehouwer, Academisch Ziekenhuis Maastricht

Brief Summary:
In type 2 diabetes (T2D), physical activity is an important modifiable risk factor of cardiovascular disease (CVD). Unfortunately (long-term) compliance to exercise programs in patients with T2D is poor. Light-intensity physical activity (LiPA) such as walking slowly, household activities or taking a flight of stairs might be a potential target for lowering the CVD risk in patients with T2D since it can perhaps be more be incorporated into daily life. To assess cardiovascular disease risk in this single-blinded RCT, the investigators settled on measuring arterial stiffness as the primary outcome. Arterial stiffness has independent predictive value for cardiovascular events and can be measured reliably and non-invasively. The investigators hypothesize that light intensity physical activity intervention program based upon increasing LiPA by replacing sedentary time is effective in lowering arterial stiffness as estimated by aortic pulse wave velocity (PWV) and carotid distensibility in individuals with T2D.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Physical Exercise Light Intensity Physical Activity Arterial Stiffness Aortic Stiffness Pulse Wave Velocity Type2 Diabetes Sedentary Lifestyle Artery Disease Physical Activity Behavioral: Interactive workshops LiPAT intervention group Device: Wrist-worn feedback physical activity monitor Device: Smartphone application LiPAT Behavioral: Telephone Coaching Behavioral: Workshops control group LiPAT Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study consists of an intervention group and a control group. Both arms run parallel and both groups are measured at the same time points.
Masking: Single (Investigator)
Masking Description: The investigator measuring the outcome measures will be blinded to patient allocation. Patients are asked not to mention their allocated group or the programme they follow and not to wear or mention the wrist-worn activity tracker during measurements.
Primary Purpose: Prevention
Official Title: The Light Intensity Physical Activity Trial
Estimated Study Start Date : February 15, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control group
Participants attend 4 workshops and undergo all measurements at t=0, t=3, t=6, and t=12 months.
Behavioral: Workshops control group LiPAT
During the first 6 months of the study (the intervention period) participants in the control group will attend 4 workshops in which the benefits of physical activity and the health-risks of sedentary behavior will be discussed. Additionally, information will be provided on healthy lifestyle for patients with type 2 diabetes.

Experimental: Intervention group
Participants attend 4 workshops, receive a wrist-worn feedback physical activity monitor, a smartphone app, and telephone coaching. All participants undergo all measurements at t=0, t=3, t=6, and t=12 months.
Behavioral: Interactive workshops LiPAT intervention group
Workshops include practical behavior change strategies and address barriers to movement, awareness of the immediate benefits of movement and implementation-intentions. Participants will be encouraged to cultivate a learning mind-set in order to better tolerate potential set-backs and to apply strategies such as pre-planning their week to incorporate physical activity, engaging their social network, and setting up systems and habits. Participants' progress in changing their physical activity patterns which will be compared and discussed.

Device: Wrist-worn feedback physical activity monitor
Participants receive the feedback monitor (i-Health Wave ®; commercially available consumer product (www.ihealthlabs.com)

Device: Smartphone application LiPAT
With a cloud-based platform the iHealth data is synchronized with a mobile phone app developed by the research team. The app is designed to help the participant to self-monitor their physical activity levels and includes information on total activity and number of steps taken.

Behavioral: Telephone Coaching
participants in the intervention group will receive telephone coaching during the first 3 months of the intervention. Telephone coaching will be conducted twice in the first month and once each in months two and three. The researcher will enquire about the progress with increasing LiPA, about the experiences of applying the strategies discussed during workshops, and about the experience with iHealth Wave ® and the corresponding app. If needed, the coach will offer suggestions to improve goal adherence.




Primary Outcome Measures :
  1. The effect of a LiPA intervention program on reducing aortic carotid-to-femoral pulse-wave velocity (PWV) in patients with type 2 diabetes. [ Time Frame: Change from baseline PWV at 6 months. ]
    Aortic (carotid to femoral) PWV will be determined by means of applanation tonometry. It will be calculated as the median of three consecutive PWV recordings.

  2. The effect of a LiPA intervention program on increasing carotid distensibility in patients with type 2 diabetes. [ Time Frame: Change from baseline carotid distensibility at 6 months. ]
    Carotid distensibility will be determined at the left common carotid by means of arterial ultrasound.


Secondary Outcome Measures :
  1. Feasibility of a LiPA intervention program on reducing sedentary time as measured by activPAL [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    Daily activity levels will be measured by activPAL3™ physical activity monitor. The participants will wear the device fixated on their upper leg for 8 consecutive days at each measurement moment. ActivPAL measures total standing time, sedentary time (sitting or lying down), and stepping time (physical activity).

  2. The effect of a LiPA intervention on changes in blood pressure. [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    Measurement of any changes in blood pressure

  3. The effect of a LiPA intervention on waist -circumference in cm. [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    Measurement of any changes in waist -circumference

  4. The effect of a LiPA intervention on quality of life as measured through the Dutch versions of the EQ-5D questionnaire. [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    The EQ-5D is a short questionnaire that covers five dimensions of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety/Depression. The EQ-5D includes 5 questions with 5 answer options each, ranging from 1 ('no problems') to 5 ('severe limitation'). A summary index with a maximum score of 1 can be computed from these five dimensions by means of a converion table. A score of 1 indicates the best health status. Additionally, there is a visual analogue scale (VAS) to indicate the general health status with scores ranging from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine').

  5. The effect of a LiPA intervention on depressive symptoms with the use a validated Dutch version of the 9-item Patient Health Questionnaire (PHQ-9). [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    The PHQ-9 is a self-administered questionnaire based on the DMS-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for a major depressive disorder. It comprises nine items rated on a 4-point scale, ranging from 0 = "not at all" to 3 = "nearly every day". The PHQ-9 scale will also be used as a dichotomous variable with a pre-defined cut-off level of 10, which represents the presence of clinically relevant depressive symptoms.

  6. Feasibility of a LiPA intervention program on increasing standing and stepping time as measured by activPAL. [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    Daily activity levels will be measured by activPAL3™ physical activity monitor. The participants will wear the device fixated on their upper leg for 8 consecutive days at each measurement moment. ActivPAL measures total standing time, sedentary time (sitting or lying down), and stepping time (physical activity). Stepping time (physical activity) is further classified into higher intensity physical activity (minutes with a step frequency >110 steps/min during waking time) and lower intensity physical activity (minutes with a step frequency ≤110 steps/min during waking time).

  7. The effect of a LiPA intervention on fasting blood glucose [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    Measurement of any changes in fasting blood glucose.

  8. The effect of a LiPA intervention on HbA1c. [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    Measurement of any changes in HbA1c.

  9. The effect of a LiPA intervention on total cholesterol. [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    Measurement of any changes in total cholesterol.

  10. The effect of a LiPA intervention on HDL- and LDL-cholesterol. [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    Measurement of any changes in HDL- and LDL-cholesterol.

  11. The effect of a LiPA intervention on triglycerides. [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    Measurement of any changes in triglycerides

  12. The effect of a LiPA intervention on glucose lowering medication. [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    Measurement of any changes in glucose lowering medication.

  13. The effect of a LiPA intervention on hip -circumference in cm. [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    Measurement of any changes in hip -circumference

  14. The effect of a LiPA intervention on body composition [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    Measurement of any changes in body composition as measured by bio electrical impedance.

  15. The effect of a LiPA intervention on quality of life as measured through the Dutch version of the SF-36 questionnaire. [ Time Frame: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12). ]
    The SF-36 is a generic and easily self-administered quality of life instrument. The SF-36 questionnaire measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health. In six of these eight dimensions, participants rate their responses on a three or six point scale. For each dimension, item scores are coded, summed, and transformed on to a scale from 0 (worst health) to 100 (best health).



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • having type 2 diabetes
  • BMI 23-33 kg/m2
  • having a sedentary lifestyle (i.e., self-reported moderate-to-vigorous physical activity < 150 minutes per week)
  • willingness to undergo randomization
  • being in the possession of personally owned smart phone

Exclusion Criteria:

  • not being able to walk for 15 minutes for any (medical) reason
  • currently engaged in an (medical) exercise program
  • plan to move out of the study area in the next 12 months
  • (digital) illiteracy or being unable to read Dutch
  • a history of any cardiovascular event (including stroke) three months prior to possible inclusion
  • a history of signs or symptoms of ischemic heart disease and(or) heart failure three months prior to possible inclusion
  • a history or signs or symptoms of peripheral arterial disease three months prior to possible inclusion
  • a history or signs or symptoms of severe diabetic neuropathy or diabetic foot ulcers three months prior to possible inclusion
  • a history of sign or symptoms of severe diabetic retinopathy three months prior to possible inclusion
  • a history or sign or symptoms of severe osteoarthritis or severe joint complaints three months prior to possible inclusion
  • a history or signs or symptoms of COPD (eligible are those participants with a COPD Gold classification ≤ I)
  • uncontrolled diabetes (i.e., uncontrolled hypo- or hyperglycaemia)
  • uncontrolled hypertension (i.e., systolic / diastolic blood pressure ≥ 180 / 95 mmHg)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415880


Contacts
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Contact: Annemarie Koster, PhD 00314382265 a.koster@maastrichtuniversity.nl

Locations
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Netherlands
Academisch Ziekenhuis Maastricht Recruiting
Maastricht, Netherlands
Sponsors and Collaborators
Academisch Ziekenhuis Maastricht
European Foundation for the Study of Diabetes
Investigators
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Principal Investigator: Coen D.A. Stehouwer, Prof. Academisch Ziekenhuis Maastricht
  Study Documents (Full-Text)

Documents provided by C.D.A. Stehouwer, Academisch Ziekenhuis Maastricht:
Study Protocol  [PDF] December 1, 2016


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Responsible Party: C.D.A. Stehouwer, Principal Investigator, Academisch Ziekenhuis Maastricht
ClinicalTrials.gov Identifier: NCT03415880     History of Changes
Other Study ID Numbers: NL57173.068.16
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by C.D.A. Stehouwer, Academisch Ziekenhuis Maastricht:
Diabetes mellitus
Type2 Diabetes
Sedentary Lifestyle
Physical Activity
Pulse wave velocity
arterial stiffness
aortic stiffness
artery disease
light intensity physical activity
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases