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

December 8, 2023 updated by: Göteborg University

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

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Angered, Sweden
        • Närhälsan Angered vårdcentral
      • Göteborg, Sweden
        • Närhälsan Biskopsgården vårdcentral
      • Göteborg, Sweden
        • Närhälsan Brämaregården vårdcentral
      • Göteborg, Sweden
        • Närhälsan Gamlestaden vårdcentral
      • Göteborg, Sweden
        • Närhälsan Kärra vårdcentral
      • Göteborg, Sweden
        • Närhälsan Tuve vårdcentral
      • Stenungsund, Sweden
        • Närhälsan Stenungsund Vårdcentral

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
Change from baseline at 1 year.

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
Change from baseline at 1 year.
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.
Change in waist circumference
Time Frame: Change from baseline at 1 year.
Waist circumference in cm measured with tape measure while standing
Change from baseline at 1 year.
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.
Change from baseline at 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2019

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

August 24, 2018

First Submitted That Met QC Criteria

October 1, 2018

First Posted (Actual)

October 3, 2018

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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