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

Primary Purpose

Diabetes Mellitus, Type 2, Physical Activity, Muscular Weakness

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Handgrip strength measurement
Standard care
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Närhälsan Angered vårdcentral
  • Närhälsan Biskopsgården vårdcentral
  • Närhälsan Brämaregården vårdcentral
  • Närhälsan Gamlestaden vårdcentral
  • Närhälsan Kärra vårdcentral
  • Närhälsan Tuve vårdcentral
  • Närhälsan Stenungsund vårdcentral

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2018
Last Updated
August 15, 2022
Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT03693521
Brief Title
Effects of Measurement of Handgrip Strength on Physical Activity Level for Patients With Diabetes Type 2
Official Title
Does Measurement of Handgrip Strength Affect Physical Activity Level for Patients With Diabetes Type 2? A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Physical Activity, Muscular Weakness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Standard care at yearly check-up by diabetes-nurse in primary care. Handgrip strength measurement bilaterally. Measurement of physical activity level.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard care at yearly check-up by diabetes-nurse in primary care. Measurement of physical activity level.
Intervention Type
Device
Intervention Name(s)
Handgrip strength measurement
Intervention Description
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
Other
Intervention Name(s)
Standard care
Intervention Description
Standard care of patients with diabetes type 2 by diabetes-nurses.
Primary Outcome Measure Information:
Title
Change in physical activity level
Description
Two questions evaluating frequency and intensity of physical activity according to recommendations by the American College of Sports Medicine and the American Heart Association.
Time Frame
Change from baseline at 1 year.
Secondary Outcome Measure Information:
Title
Change in handgrip strength
Description
Handgrip strength in kg measured with Jamar hand dynamometer
Time Frame
Change from baseline at 1 year.
Title
Change in HbA1c
Description
Blood test. HbA1c level measured in mmol/mol
Time Frame
Change from baseline at 1 year.
Title
Change in waist circumference
Description
Waist circumference in cm measured with tape measure while standing
Time Frame
Change from baseline at 1 year.
Title
Physical Activity on Prescription
Description
Total number of prescriptions for physical activity issued by participating diabetes-nurses. Differences measured between groups.
Time Frame
Change from baseline at 1 year.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margareta Hellgren, PhD
Organizational Affiliation
Närhälsan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maria EH Larsson, PhD
Organizational Affiliation
Närhälsan
Official's Role
Study Director
Facility Information:
Facility Name
Närhälsan Angered vårdcentral
City
Angered
Country
Sweden
Facility Name
Närhälsan Biskopsgården vårdcentral
City
Göteborg
Country
Sweden
Facility Name
Närhälsan Brämaregården vårdcentral
City
Göteborg
Country
Sweden
Facility Name
Närhälsan Gamlestaden vårdcentral
City
Göteborg
Country
Sweden
Facility Name
Närhälsan Kärra vårdcentral
City
Göteborg
Country
Sweden
Facility Name
Närhälsan Tuve vårdcentral
City
Göteborg
Country
Sweden
Facility Name
Närhälsan Stenungsund vårdcentral
City
Stenungsund
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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