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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Physical Activity; Muscular Weakness
• Interventions: Device: Handgrip strength measurement; Other: Standard care

• Registration Number: NCT03693521
• Lead Sponsor: Göteborg University

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

Not available

Study Timeline

• Study First Submitted: 2018-08-24
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-03
• Study Start: 2019-10-07
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in physical activity level	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.

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Närhälsan Biskopsgården vårdcentral; 🇸🇪 Göteborg, Sweden

Närhälsan Angered vårdcentral; 🇸🇪 Angered, Sweden

Närhälsan Brämaregården vårdcentral; 🇸🇪 Göteborg, Sweden

Närhälsan Kärra vårdcentral; 🇸🇪 Göteborg, Sweden

Närhälsan Gamlestaden vårdcentral; 🇸🇪 Göteborg, Sweden

Närhälsan Tuve vårdcentral; 🇸🇪 Göteborg, Sweden

Närhälsan Stenungsund vårdcentral; 🇸🇪 Stenungsund, Sweden