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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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This pilot study evaluates potential biological and psychological effects of Swedish massage in adults with type 1 diabetes. Massage may influence stress-related mechanisms, such as hypothalamic-pituitary-adrenal (HPA) axis activity and inflammation, which are linked to impaired insulin sensitivity and glycemic control. Twenty participants with type 1 diabetes will receive weekly 45-60-minute Swedish massage sessions for five weeks. Biological outcomes include HbA1c, fasting glucose, copeptin, hs-CRP, IL-6, and TNF-α. Glycemic variability will be assessed using continuous glucose monitoring (CGM). Psychological outcomes include perceived stress (PSS-10) and anxiety (GAD-7). The study aims to explore feasibility, acceptability, and preliminary within-group effects on stress regulation and glycemic balance
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Swedish Massage | Experimental | Participants receive Swedish massage once weekly for five consecutive weeks. Each session lasts 45-60 minutes and is delivered by a licensed massage therapist. Techniques include kneading, gliding, and tapping of soft tissues, focusing on the back, shoulders, and neck. The massage is designed to promote relaxation and modulate stress-related biological systems |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swedish massage | Behavioral | Participants receive Swedish massage once weekly for five consecutive weeks. Each 45-60-minute session is delivered by a licensed massage therapist using traditional Swedish techniques (kneading, gliding, and tapping) focusing on the back, shoulders, and neck. The intervention aims to promote relaxation and modulate stress-related biological systems. The study uses a single-group pre-post design to explore biological and psychological effects and feasibility. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of HbA1c (mmol/mol) | This measure is part of the study's limited efficacy evaluation and is used to explore preliminary within-group changes in preparation for a future randomized trial. HbA1c (mmol/mol), measured from fasting blood samples. Lower values indicate improved glycemic control. | Change from baseline to within 7 days after the fifth massage session (5 weeks). |
| Concentration of Copeptin (pmol/L) | Limited efficacy outcome assessing preliminary within-group changes related to physiological stress. Copeptin measured from fasting serum samples. Lower concentrations indicate reduced stress system activation. | Baseline and within 7 days after final massage (5 weeks). |
| Concentration of high-sensitivity C-reactive protein, hs-CRP (mg/L) | Limited efficacy outcome assessing preliminary within-group inflammatory changes. Lower concentrations indicate reduced systemic inflammation | Change from baseline to within 7 days after the fifth massage session (5 weeks). |
| Concentration of Interleukin-6 (IL-6) (pg/mL) | Limited efficacy outcome assessing preliminary within-group inflammatory changes. Lower IL-6 levels indicate reduced inflammatory activation. | Change from baseline to within 7 days after the fifth massage session (5 weeks). |
| Mean interstitial glucose (mmol/L) measured by continuous glucose monitoring (CGM) | Limited efficacy outcome assessing preliminary within-group changes in glycemic control. Mean interstitial glucose derived from CGM. Lower values indicate improved glycemic control. | Change from baseline to within 7 days after the fifth massage session (5 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | This measure is part of the study's limited efficacy evaluation and is used to explore preliminary within-group changes in preparation for a future randomized trial. Clinic systolic blood pressure (mmHg), measured in a seated position after rest according to standard procedures. Lower values indicate improved cardiovascular risk profile. | Baseline and within 7 days after the final massage session (5 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Metabolic and Inflammatory Markers | Additional biomarkers related to stress physiology, inflammation, or short-term glycemic control may be analyzed if relevant and assay-ready samples are available (e.g., additional cytokines, oxidative stress markers, or alternative glycemic indices). These outcomes are exploratory and not required for completion of the study. | Change from baseline to within 7 days after the fifth massage session (5 weeks). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Johansson, Professor/RN | Contact | 460700896548 | peter.b.johansson@liu.se | |
| Magnus Wijkman, PhD/MD | Contact | magnus.wijkman@liu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter Johansson | Norrköping | Linköpings Universitet | 601 74 | Sweden |
Individual participant data will not be shared publicly due to the small sample size and sensitive clinical information. De-identified summary data may be available upon reasonable request to the principal investigator for research purposes.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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All participants receive Swedish massage once weekly for five weeks. Pre-post within-group design to explore biological and psychological effects and study feasibility.
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Open-label single-group pilot study; neither participants nor investigators are blinded.
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| Glycemic variability (Coefficient of Variation, %), measured by CGM |
Limited efficacy outcome assessing preliminary within-group changes in glycemic stability. Lower %CV indicates more stable glucose levels. |
| Change from baseline to within 7 days after the fifth massage session (5 weeks). |
| Time in Range (percentage of CGM readings between 3.9-10 mmol/L) | Limited efficacy outcome assessing preliminary within-group glycemic control. Higher percentages indicate improved glucose regulation. | Change from baseline to within 7 days after the fifth massage session (5 weeks). |
| Score on the Perceived Stress Scale-10 (PSS-10) | Limited efficacy outcome assessing preliminary within-group psychological changes. The PSS-10 is a 10-item scale ranging 0-40, with higher scores indicating greater perceived stress. | Change from baseline to within 7 days after the fifth massage session (5 weeks). |
| Score on the Generalized Anxiety Disorder-7 (GAD-7) | Limited efficacy outcome assessing preliminary within-group psychological changes. The GAD-7 ranges 0-21, with higher scores indicating more severe anxiety. | Change from baseline to within 7 days after the fifth massage session (5 weeks). |
| Concentration of fasting plasma glucose (mmol/L) | Limited efficacy outcome assessing preliminary within-group metabolic changes prior to a future randomized trial. Fasting plasma glucose (mmol/L), with lower values indicating improved glycemic control. | Change from baseline to within 7 days after the fifth massage session (5 weeks). |
| Change in Diastolic Blood Pressure | This measure is part of the study's limited efficacy evaluation and is used to explore preliminary within-group changes in preparation for a future randomized trial. Clinic systolic diastolic pressure (mmHg), measured in a seated position after rest according to standard procedures. Lower values indicate improved cardiovascular risk profile. | Baseline and within 7 days after the final massage session (5 weeks). |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |