Diabetes Mellitus, Type 2NCT03693521
Effects of Measurement of Handgrip Strength on Physical Activity Level for Patients With Diabetes Type 2
A study testing Handgrip strength measurement in people with Diabetes Mellitus, Type 2 and Physical Activity, run by Göteborg University at 7 sites in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2, Physical Activity, Muscular Weakness
- What is being tested?
- Handgrip strength measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 7 sitesSweden
- Study dates
- 7 Oct 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No gender, age or language restrictions.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Närhälsan Angered vårdcentral
Angered
Närhälsan Biskopsgården vårdcentral
Gothenburg
Närhälsan Brämaregården vårdcentral
Gothenburg
Närhälsan Gamlestaden vårdcentral
Gothenburg
Närhälsan Kärra vårdcentral
Gothenburg
Närhälsan Tuve vårdcentral
Gothenburg
Närhälsan Stenungsund vårdcentral
Stenungsund
About this study
Official title: Does Measurement of Handgrip Strength Affect Physical Activity Level for Patients With Diabetes Type 2? A Randomized Controlled Trial
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.
Read more
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.
- Being tested
- Handgrip strength measurement, Standard care
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handgrip strength measurementDevice
Measurement of handgrip strength with Jamar hand-held dynamometer as a complement to standard care of patients with diabetes type 2 by diabetes-nurses.
Standard careOther
Standard care of patients with diabetes type 2 by diabetes-nurses.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Standard care at yearly check-up by diabetes-nurse in primary care. Handgrip strength measurement bilaterally. Measurement of physical activity level. Receives: 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. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 1 year.
Secondary outcomes (4)
Change in handgrip strength
Handgrip strength in kg measured with Jamar hand dynamometer
Measured: Change from baseline at 1 year.
Change in HbA1c
Blood test. HbA1c level measured in mmol/mol
Measured: Change from baseline at 1 year.
Change in waist circumference
Waist circumference in cm measured with tape measure while standing
Measured: Change from baseline at 1 year.
Physical Activity on Prescription
Total number of prescriptions for physical activity issued by participating diabetes-nurses. Differences measured between groups.
Measured: Change from baseline at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start7 Oct 2019
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Margareta Hellgren, PhD, Study director, NärhälsanMaria EH Larsson, PhD, Study director, Närhälsan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693521
- Sponsor's protocol ID
- VGFOUREG-751161
- Status last verified
- Dec 2023
- First submitted
- 24 Aug 2018
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38963325
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Measurement of Handgrip Strength Affect Physical Activity Level for Patients With Diabetes Type 2? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03693521
- Acronym / sponsor ID
- VGFOUREG-751161
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Handgrip strength measurement, Other: Standard careStandard care at yearly check-up by diabetes-nurse in primary care. Handgrip strength measurement bilaterally. Measurement of physical activity level. |
| Control group | Active comparator | Other: Standard careStandard care at yearly check-up by diabetes-nurse in primary care. Measurement of physical activity level. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- No gender, age or language restrictions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handgrip strength measurementMeasurement of handgrip strength with Jamar hand-held dynamometer as a complement to standard care of patients with diabetes type 2 by diabetes-nurses. | Device | Intervention group |
| Standard careStandard care of patients with diabetes type 2 by diabetes-nurses. | Other | Control group, Intervention group |
Primary outcome
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.
4 secondary outcomes
Change in handgrip strength
Time frame: Change from baseline at 1 year.
Change in HbA1c
Time frame: Change from baseline at 1 year.
Change in waist circumference
Time frame: Change from baseline at 1 year.
Physical Activity on Prescription
Time frame: Change from baseline at 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Derived from this study: PubMed 38963325Bornhoft 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margareta Hellgren, PhD study director
Närhälsan
Maria EH Larsson, PhD study director
Närhälsan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handgrip strength measurement in people with Diabetes Mellitus, Type 2 and Physical Activity, run by Göteborg University at 7 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity level (time frame: Change from baseline at 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03693521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.