Effects of Measurement of Handgrip Strength on Physical Activity Level for Patients With Diabetes Type 2

Study Overview
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Brief Summary
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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.

Official Title
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Does Measurement of Handgrip Strength Affect Physical Activity Level for Patients With Diabetes Type 2? A Randomized Controlled Trial

Conditions
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Diabetes Mellitus, Type 2, Physical Activity, Muscular Weakness

Intervention / Treatment
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* Device: Handgrip strength measurement
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Standard care at yearly check-up by diabetes-nurse in primary care. Handgrip strength measurement bilaterally. Measurement of physical activity level. | Device: Handgrip strength measurement<br>* Measurement of handgrip strength with Jamar hand-held dynamometer as a complement to standard care of patients with diabetes type 2 by diabetes-nurses.<br>Other: Standard care<br>* Standard care of patients with diabetes type 2 by diabetes-nurses.<br>|
| Active Comparator: Control group<br>Standard care at yearly check-up by diabetes-nurse in primary care. Measurement of physical activity level. | Other: Standard care<br>* Standard care of patients with diabetes type 2 by diabetes-nurses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity level | Two questions evaluating frequency and intensity of physical activity according to recommendations by the American College of Sports Medicine and the American Heart Association. | Change from baseline at 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in handgrip strength | Handgrip strength in kg measured with Jamar hand dynamometer | Change from baseline at 1 year. | 
| Change in HbA1c | Blood test. HbA1c level measured in mmol/mol | Change from baseline at 1 year. | 
| Change in waist circumference | Waist circumference in cm measured with tape measure while standing | Change from baseline at 1 year. | 
| Physical Activity on Prescription | Total number of prescriptions for physical activity issued by participating diabetes-nurses. Differences measured between groups. | Change from baseline at 1 year. |