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

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ClinicalTrials.gov Identifier: NCT03693521
Recruitment Status : Not yet recruiting
First Posted : October 3, 2018
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Physical Activity Muscular Weakness Device: Handgrip strength measurement Other: Standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Does Measurement of Handgrip Strength Affect Physical Activity Level for Patients With Diabetes Type 2? A Randomized Controlled Trial
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
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
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.

Active Comparator: Control group
Standard care at yearly check-up by diabetes-nurse in primary care. Measurement of physical activity level.
Other: Standard care
Standard care of patients with diabetes type 2 by diabetes-nurses.




Primary Outcome Measures :
  1. Change in physical activity level [ Time Frame: 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 :
  1. Change in handgrip strength [ Time Frame: Change from baseline at 1 year. ]
    Handgrip strength in kg measured with Jamar handdynamometer

  2. Change in HbA1c [ Time Frame: Change from baseline at 1 year. ]
    Blood test. HbA1c level measured in mmol/mol

  3. Change in waist circumference [ Time Frame: Change from baseline at 1 year. ]
    Waist circumference in cm measured with tape measure while standing

  4. Physical Activity on Prescription [ Time Frame: Change from baseline at 1 year. ]
    Total number of prescriptions for physical activity issued by participating diabetes-nurses. Differences measured between groups.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693521


Contacts
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Contact: Lena Bornhöft, MSc +46 31 7479444 lena.bornhoft@vgregion.se

Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Investigators
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Study Director: Margareta Hellgren, PhD Närhälsan
Study Director: Maria EH Larsson, PhD Närhälsan

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03693521     History of Changes
Other Study ID Numbers: VGFOUREG-751161
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Weakness
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms