- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03693521
Effects of Measurement of Handgrip Strength on Physical Activity Level for Patients With Diabetes Type 2
Does Measurement of Handgrip Strength Affect Physical Activity Level for Patients With Diabetes Type 2? A Randomized Controlled Trial
Background: It is recommended that patients with diabetes type 2 keep themselves physically active and it is known that good muscular strength has a positive effect on these patients.
Aim: To determine whether physical activity level increases and whether other risk factors for cardiovascular disease are positively affected by including measurement of handgrip strength as part of the regular care program for patients with diabetes type 2 in primary care.
Method: Patients with diabetes type 2 who go to regular check-ups by participating diabetes-nurses in primary care are randomized to either intervention or control group. In the intervention group, handgrip strength is measured in addition to standard care. the control group receives standard care at inclusion. Handgrip strength is measured in both groups at 1 year follow-up. Physical activity level is measured in both groups at inclusion and 1 year follow-up with a questionnaire. Measurement of other risk factors for cardiovascular morbidity are measured at both inclusion and follow-up in both groups as dictated by standard care routines.
Expected results: Measurement of handgrip strength can give health care personnel greater possibilities to identify those patients with diabetes type 2 who need to increase their activity level and to give them more concrete support. It is possible that the attention given to handgrip strength and physical activity may motivate patients to increase their activity level, become stronger and eventually reduce other risk factors for cardiovascular morbidity.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Angered, Sweden
- Närhälsan Angered vårdcentral
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Göteborg, Sweden
- Närhälsan Biskopsgården vårdcentral
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Göteborg, Sweden
- Närhälsan Brämaregården vårdcentral
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Göteborg, Sweden
- Närhälsan Gamlestaden vårdcentral
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Göteborg, Sweden
- Närhälsan Kärra vårdcentral
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Göteborg, Sweden
- Närhälsan Tuve vårdcentral
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Stenungsund, Sweden
- Närhälsan Stenungsund Vårdcentral
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with diabetes type 2 who go to regular check-ups with participating diabetes-nurses at primary health care centres in Region Västra Götaland, Sweden.
Exclusion Criteria:
- No gender, age or language restrictions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Standard care at yearly check-up by diabetes-nurse in primary care.
Handgrip strength measurement bilaterally.
Measurement of physical activity level.
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Measurement of handgrip strength with Jamar hand-held dynamometer as a complement to standard care of patients with diabetes type 2 by diabetes-nurses.
Standard care of patients with diabetes type 2 by diabetes-nurses.
|
|
Active Comparator: Control group
Standard care at yearly check-up by diabetes-nurse in primary care.
Measurement of physical activity level.
|
Standard care of patients with diabetes type 2 by diabetes-nurses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in physical activity level
Time Frame: Change from baseline at 1 year.
|
Two questions evaluating frequency and intensity of physical activity according to recommendations by the American College of Sports Medicine and the American Heart Association.
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Change from baseline at 1 year.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in handgrip strength
Time Frame: Change from baseline at 1 year.
|
Handgrip strength in kg measured with Jamar hand dynamometer
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Change from baseline at 1 year.
|
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Change in HbA1c
Time Frame: Change from baseline at 1 year.
|
Blood test.
HbA1c level measured in mmol/mol
|
Change from baseline at 1 year.
|
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Change in waist circumference
Time Frame: Change from baseline at 1 year.
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Waist circumference in cm measured with tape measure while standing
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Change from baseline at 1 year.
|
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Physical Activity on Prescription
Time Frame: Change from baseline at 1 year.
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Total number of prescriptions for physical activity issued by participating diabetes-nurses.
Differences measured between groups.
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Change from baseline at 1 year.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Margareta Hellgren, PhD, Närhälsan
- Study Director: Maria EH Larsson, PhD, Närhälsan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VGFOUREG-751161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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