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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

August 24, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 1, 2018

Estimated Primary Completion Date

October 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

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

Condition ^ICMJE

Intervention ^ICMJE

Device: Handgrip strength measurement
Measurement of handgrip strength with Jamar hand-held dynamometer as a complement to standard care of patients with diabetes type 2 by diabetes-nurses.
Other: Standard care
Standard care of patients with diabetes type 2 by diabetes-nurses.

Study Arms

Experimental: Intervention group
Standard care at yearly check-up by diabetes-nurse in primary care. Handgrip strength measurement bilaterally. Measurement of physical activity level.
Active Comparator: Control group
Standard care at yearly check-up by diabetes-nurse in primary care. Measurement of physical activity level.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

800

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 1, 2020

Estimated Primary Completion Date

October 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

N/A and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Göteborg University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Margareta Hellgren, PhD Närhälsan
Study Director: Maria EH Larsson, PhD Närhälsan

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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