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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03693521
• Other study ID #: VGFOUREG-751161
• Status: Completed
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: December 2023
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Muscle Weakness
• Muscular Weakness
• Physical Activity

Intervention

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.

Locations

Country	Name	City	State
Sweden	Närhälsan Angered vårdcentral	Angered
Sweden	Närhälsan Biskopsgården vårdcentral	Göteborg
Sweden	Närhälsan Brämaregården vårdcentral	Göteborg
Sweden	Närhälsan Gamlestaden vårdcentral	Göteborg
Sweden	Närhälsan Kärra vårdcentral	Göteborg
Sweden	Närhälsan Tuve vårdcentral	Göteborg
Sweden	Närhälsan Stenungsund vårdcentral	Stenungsund

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in handgrip strength	Handgrip strength in kg measured with Jamar hand dynamometer	Change from baseline at 1 year.
Secondary	Change in HbA1c	Blood test. HbA1c level measured in mmol/mol	Change from baseline at 1 year.
Secondary	Change in waist circumference	Waist circumference in cm measured with tape measure while standing	Change from baseline at 1 year.
Secondary	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.