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

NCT ID: NCT03693521

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-07

Study Completion Date

2023-06-30

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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Physical Activity Muscular Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Standard care at yearly check-up by diabetes-nurse in primary care. Handgrip strength measurement bilaterally. Measurement of physical activity level.

Group Type EXPERIMENTAL

Handgrip strength measurement

Intervention Type DEVICE

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

Intervention Type OTHER

Standard care of patients with diabetes type 2 by diabetes-nurses.

Control group

Standard care at yearly check-up by diabetes-nurse in primary care. Measurement of physical activity level.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

Standard care of patients with diabetes type 2 by diabetes-nurses.

Interventions

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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.

Intervention Type DEVICE

Standard care

Standard care of patients with diabetes type 2 by diabetes-nurses.

Intervention Type OTHER

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margareta Hellgren, PhD

Role: STUDY_DIRECTOR

Närhälsan

Maria EH Larsson, PhD

Role: STUDY_DIRECTOR

Närhälsan

Locations

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Närhälsan Angered vårdcentral

Angered, , Sweden

Site Status

Närhälsan Biskopsgården vårdcentral

Gothenburg, , Sweden

Site Status

Närhälsan Brämaregården vårdcentral

Gothenburg, , Sweden

Site Status

Närhälsan Gamlestaden vårdcentral

Gothenburg, , Sweden

Site Status

Närhälsan Kärra vårdcentral

Gothenburg, , Sweden

Site Status

Närhälsan Tuve vårdcentral

Gothenburg, , Sweden

Site Status

Närhälsan Stenungsund vårdcentral

Stenungsund, , Sweden

Site Status

Countries

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Sweden

References

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Bornhoft L, Bernhardsson S, Nordeman L, Grimby-Ekman A, Dottori M, Larsson MEH. Monitoring handgrip strength to motivate lifestyle choices for patients with diabetes type 2 - a pragmatic randomised controlled trial. Scand J Prim Health Care. 2024 Dec;42(4):617-632. doi: 10.1080/02813432.2024.2373298. Epub 2024 Jul 4.

Reference Type DERIVED
PMID: 38963325 (View on PubMed)

Other Identifiers

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VGFOUREG-751161

Identifier Type: -

Identifier Source: org_study_id