The effect of controlled swinging movement on prediabetic and diabetic patients
| ISRCTN | ISRCTN11690727 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11690727 |
- Submission date
- 06/11/2019
- Registration date
- 13/11/2019
- Last edited
- 20/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high and is a universal social catastrophe. There are 425 million cases of diabetes in the world. The amount of sugar in the blood is controlled by a hormone called insulin, which is produced by the pancreas (a gland behind the stomach). When food is digested and enters the bloodstream, insulin moves glucose out of the blood and into cells, where it's broken down to produce energy. However, with diabetes, the body is unable to break down glucose into energy. This is because there's either not enough insulin to move the glucose, or the insulin produced does not work properly.
A gentle swinging motion of the whole body (controlled vestibular stimulation) can have an effect on the production of other hormones in the body which may reduce the damage caused by high blood sugar (hyperglycaemia). The study aims to evaluate the effect of controlled vestibular stimulation on anxiety, blood pressure, blood glucose levels in prediabetes and type 2 diabetes
Who can participate?
Prediabetic and diabetic (type 2) patients aged 30-60 years
What does the study involve?
Vestibular stimulation (rocking using a swing for 20 minutes per day for three months) is given as an intervention and changes in measures of diabetes symptoms will be measured before and after the intervention
What are the possible benefits and risks of participating?
Controlled vestibular stimulation helps in controlling anxiety, blood pressure, blood glucose levels and oxidative injury caused by hyperglycaemia. There is no risk involved in participating in the study as it is a noninvasive intervention.
Where is the study run from?
Little Flower Hospital and Research centre, India
When is the study starting and how long is it expected to run for?
August 2016 to April 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Remya Paul
remyapaul.k@gmail.com
Contact information
Public
Little Flower Medical Research Centre
Angamaly
Kerala
683572
India
 ORCID ID |
0000-0002-1761-5664 |
|---|---|
| Phone | +91(0)484 2675000 |
| remyapaul.k@gmail.com |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Modulation of physiological and biochemical parameters by controlled vestibular stimulation in prediabetes and Type 2 diabetes mellitus |
| Study acronym | CVS |
| Study objectives | There will be a significant difference in biochemical and physiological parameters of prediabetic and type 2 diabetic patients before and after controlled vestibular stimulation |
| Ethics approval(s) | Approved 03/08/2016, Institutional ethics committee of Little Flower Hospital and Research Centre (Angamaly, Kerala, India; +91 484 2452546; admin@lfhospital.org), ref: IEC / LFMRC/ 2016/1 |
| Health condition(s) or problem(s) studied | Prediabetes and Type 2 Diabetes Mellitus |
| Intervention | Prediabetic patients and Type 2 diabetic patients were randomly divided into experimental and control groups by block randomization with equal numbers of patients in each group. Controlled vestibular stimulation is provided to the subjects in the two experimental groups by using a swing to produce a to and fro motion 20 minutes per day for 3 months. Physiological and biochemical parameters were taken from all patients before starting of intervention and after 3 months |
| Intervention type | Other |
| Primary outcome measure | Blood glucose levels measured using fasting blood sugar and HbA1c at baseline and three months |
| Secondary outcome measures | At baseline and three months: 1. Anthropometry: 1.1. Waist to Hip Ratio (cm) 1.2. Body Mass Index (BMI) (kg/m²) 2. Physiological variables: 2.1. Heart rate (bpm) 2.2. Blood pressure (mmHg) 2.3. SPO2 3. Anxiety level measured using the stress assessment questionnaire - STAI (State Trait Anxiety Inventory) 4. Lipid profile (blood test): 4.1. Total Cholesterol (TC) 4.2. High Density Lipoprotein (HDL) 4.3. Low Density Lipoprotein (LDL) 4.4. Very Low Density Lipoprotein (VLDL) 4.5. Triglycerides (TG) 4.6. TC/HDL Ratio 5. Oxidative stress markers (blood test): 5.1. Malondialdehyde level (MDA) (spectrophotometric method) 5.2. Superoxide dismutase (SOD) (spectrophotometric method) |
| Overall study start date | 04/08/2016 |
| Completion date | 04/04/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 240 |
| Total final enrolment | 240 |
| Key inclusion criteria | Current inclusion criteria as of 19/05/2021: Pre-Diabetic patients: 1. Fasting blood glucose level between 100 mg/dl and 125 mg/dl or HbA1C between 5.7% and 6.4% 2. Male and female patients aged 30-60 years Diabetic patients: 3. Fasting blood glucose level >126 mg/dl or HbA1C >6.4% or taking oral hypoglycemic agents or insulin 4. Male and female patients aged 30-60 years Previous inclusion criteria: Pre-Diabetic patients: 1. Fasting blood glucose level between 100 mg/dl and 125 mg/dl or HbA1C between 5.7% and 6.4% 2. Male and female patient with age 20 - 70 years Diabetic patients: 3. Fasting blood glucose level >126 mg/dl or HbA1C >6.4% or taking oral hypoglycemic agents or insulin 4. Male and female patient with age 20 - 70 years |
| Key exclusion criteria | 1. Type 1 diabetes mellitus or gestational diabetes mellitus 2. Undergone any vestibular stimulation programs 3. Critically ill 4. Diagnosed with any cardiac diseases, cerebrovascular, renal diseases and liver diseases 5. On oral medication for hypertension and hyperlipidemia 6. Any planned surgery during the course of study 7. Pregnant or planning to get pregnant during the course of study 8. Taking vitamin supplements 9. Chronic smokers and severe alcoholic 10. Current continuous renal replacement therapy 11. Current use of steroids 12. Previous or current treatment with deep brain stimulation 13. Previous known disease, injury, or surgical intervention involving the brain or central nervous system 14. Moderate or greater hearing loss or presence of a cochlear implant 15. Diagnosed vestibular dysfunction 16. Any history of previous ear or eye surgery 17. Active ear infections or a perforated tympanic membrane 18. Presence of a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study |
| Date of first enrolment | 30/08/2016 |
| Date of final enrolment | 30/04/2019 |
Locations
Countries of recruitment
- India
Study participating centre
Kerala
683572
India
Sponsor information
Hospital/treatment centre
-
Angamaly
683572
India
| Phone | +91(0)484 2458327 |
|---|---|
| lfmrcang@gmail.com | |
| Website | http://www.lfhospital.org |
"ROR" |
https://ror.org/0375jhj23 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 20/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/07/2020 | 19/05/2021 | Yes | No |
Editorial Notes
19/05/2021: Publication reference and total final enrolment added, inclusion criteria updated.
14/11/2019: Internal review.
07/11/2019: Trial’s existence confirmed by Institutional ethics committee of Little Flower Hospital and Research Centre
