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

NCT03693521 | Completed

• 1 other identifier: VGFOUREG-751161
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 7

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.

Conditions

Diabetes Mellitus, Type 2; Physical Activity; Muscular Weakness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in handgrip strength

  Change from baseline at 1 year.

• Change in HbA1c

  Change from baseline at 1 year.

• Change in waist circumference

  Change from baseline at 1 year.

• Physical Activity on Prescription

  Change from baseline at 1 year.

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Device: Handgrip strength measurement; Other: Standard care

Control group

ACTIVE COMPARATOR

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

Other: Standard care

Interventions

Handgrip strength measurement 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.

Intervention group

Standard care OTHER

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

Control group; Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No gender, age or language restrictions.

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (7)

Närhälsan Angered vårdcentral

Angered, Sweden

Location

Närhälsan Biskopsgården vårdcentral

Gothenburg, Sweden

Location

Närhälsan Brämaregården vårdcentral

Gothenburg, Sweden

Location

Närhälsan Gamlestaden vårdcentral

Gothenburg, Sweden

Location

Närhälsan Kärra vårdcentral

Gothenburg, Sweden

Location

Närhälsan Tuve vårdcentral

Gothenburg, Sweden

Location

Närhälsan Stenungsund vårdcentral

Stenungsund, Sweden

Location

Related Publications (1)

• 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.

  PMID: 38963325 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Muscle Weakness

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Margareta Hellgren, PhD

  Närhälsan

  STUDY DIRECTOR

• Maria EH Larsson, PhD

  Närhälsan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: October 3, 2018
• Study Start: October 7, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (7)