Clinical trial NCT03693521: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Physical Activity
Muscular Weakness
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2018-10-03
Enrollment: 334
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change in physical activity level
timeFrame: Change from baseline at 1 year.
Secondary outcomes:
measure: Change in handgrip strength
timeFrame: Change from baseline at 1 year.
measure: Change in HbA1c
timeFrame: Change from baseline at 1 year.
measure: Change in waist circumference
timeFrame: Change from baseline at 1 year.
measure: Physical Activity on Prescription
timeFrame: Change from baseline at 1 year.
Other outcomes:
Locations:
city: Angered
country: Sweden
facility: Närhälsan Angered vårdcentral
city: Göteborg
country: Sweden
facility: Närhälsan Biskopsgården vårdcentral
city: Göteborg
country: Sweden
facility: Närhälsan Brämaregården vårdcentral
city: Göteborg
country: Sweden
facility: Närhälsan Gamlestaden vårdcentral
city: Göteborg
country: Sweden
facility: Närhälsan Kärra vårdcentral
city: Göteborg
country: Sweden
facility: Närhälsan Tuve vårdcentral
city: Stenungsund
country: Sweden
facility: Närhälsan Stenungsund vårdcentral
Study officials:
affiliation: Närhälsan
name: Margareta Hellgren, PhD
role: STUDY_DIRECTOR
affiliation: Närhälsan
name: Maria EH Larsson, PhD
role: STUDY_DIRECTOR
References: