Role of Tele-physical Therapy in Patients With Type 2 Diabetes Mellitus Following COVID-19 Infection.

COVID-19 Clinical Trial

Official title:

Role of Tele-physical Therapy Training on Glycemic Control, Pulmonary Function, Physical Fitness, and Health-related Quality of Life in Patients With Type 2 Diabetes Mellitus Following COVID-19 Infection - a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05599893
• Other study ID #: RHPT/021/085
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Prince Sattam Bin Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diabetes mellitus (DM) is a chronic metabolic disease where the body is unable to metabolize carbohydrates properly either due to a lack of insulin production or abnormal insulin function. In recent times, it has been considered a global healthcare concern because of its high prevalence rate (9.2 %) and other associated health consequences. After being infected with Coronavirus disease-2019 (COVID-19), the Type 2 Diabetes mellitus (T2DM) sufferer experiences the following symptoms; reduced exercise tolerance, decreased muscle strength, altered respiratory functions, cognitive impairments and abnormal psychosomatic behaviour, which affects the overall well-being of the patient. To prevent or delay these clinical features and the associated consequences of type 2 Diabetes mellitus, the regular body works out and physical training is suggested either alone or in combination with diet modification. In this study, we tested the hypothesis that 12 months of supervised tele-physical therapy can positively influence patients with type 2 diabetes mellitus following COVID-19 infection. The reports of the study would be helpful for the clinicians and the physical therapists to make this as evidence for using tele-physical therapy in type 2 Diabates mellitus patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Participants between 18-60 years of age and being diagnosed with COVID-19 with mild dyspnea and type 2 DM and the ability to use smart mobile phones were selected to be included in the study.

Exclusion Criteria:

• Participants who had neurological (radiculopathy, myelopathy and disc problems) and orthopedic problems, cardio-pulmonary diseases (stroke, hypertension and syncope), other metabolic and endocrinal problems, metastasis, pregnancy, taking analgesics or corticosteroids, any contra indications to physical exercises (fracture, instability, osteoporosis, arthropathy and neural symptoms) and cognitive and mental disorder were excluded.

Related Conditions & MeSH terms

• COVID-19
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Tele physical therapy
Before commencing training, warm-up exercises involving upper and lower extremity joint movements were performed for 10 times. During the first and second weeks, the third and fourth weeks, the fifth and sixth weeks and the seventh and eighth weeks, the exercises were performed 10-15, 15-20, 20-25 and 25-30 times per session, respectively. Each session lasted for 10 minutes of warm up, 60 minutes of training and 10 minutes of cool down phase. The participants in the TPG received training four times a week, for 8 weeks, each session lasted for 60 minutes.
• Patient educationa and Conventional exercises
They were informed to do their normal daily activities, avoid a sedentary lifestyle, perform regular physical activities such as household activities, maintain a balanced diet and have 6-8 hours of sleep per day.

Locations

Country	Name	City	State
Saudi Arabia	Gopal Nambi	Al Kharj	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic level	The hemoglobin A1C test, also known as HbA1c test. It is a simple blood test which measures the blood sugar levels of the participants.	Baseline
Primary	Glycemic level	The hemoglobin A1C test, also known as HbA1c test. It is a simple blood test which measures the blood sugar levels of the participants.	8 weeks
Primary	Glycemic level	The hemoglobin A1C test, also known as HbA1c test. It is a simple blood test which measures the blood sugar levels of the participants.	6 months
Primary	Glycemic level	The hemoglobin A1C test, also known as HbA1c test. It is a simple blood test which measures the blood sugar levels of the participants.	12 months
Secondary	Forced Expiratory volume 1	It measures the forced expiratory volume in the first second (FEV1) in litres	Baseline
Secondary	Forced Expiratory volume 1	It measures the forced expiratory volume in the first second (FEV1) in litres	8 weeks
Secondary	Forced Expiratory volume 1	It measures the forced expiratory volume in the first second (FEV1) in litres	6 months
Secondary	Forced Expiratory volume 1	It measures the forced expiratory volume in the first second (FEV1) in litres	12 months
Secondary	Forced vital capacity	It measures the forced vital capacity (FVC) in litres.	Baseline
Secondary	Forced vital capacity	It measures the forced vital capacity (FVC) in litres.	8 weeks
Secondary	Forced vital capacity	It measures the forced vital capacity (FVC) in litres.	6 months
Secondary	Forced vital capacity	It measures the forced vital capacity (FVC) in litres.	12 months
Secondary	Forced vital capacity/Forced Expiratory volume 1	It measures the forced expiratory volume1/forced vital capacity in percentage.	Baseline
Secondary	Forced vital capacity/Forced Expiratory volume 1	It measures the forced expiratory volume1/forced vital capacity in percentage.	8 weeks
Secondary	Forced vital capacity/Forced Expiratory volume 1	It measures the forced expiratory volume1/forced vital capacity in percentage.	6 months
Secondary	Forced vital capacity/Forced Expiratory volume 1	It measures the forced expiratory volume1/forced vital capacity in percentage.	12 months
Secondary	Maximum voluntary ventilation	It measures the maximum voluntary ventilation (MVV) in liters/minute.	Baseline
Secondary	Maximum voluntary ventilation	It measures the maximum voluntary ventilation (MVV) in liters/minute.	8 weeks
Secondary	Maximum voluntary ventilation	It measures the maximum voluntary ventilation (MVV) in liters/minute.	6 months
Secondary	Maximum voluntary ventilation	It measures the maximum voluntary ventilation (MVV) in liters/minute.	12 months
Secondary	Peak exploratory flow	It measures the peak exploratory flow (PEF) in liters/second.	Baseline
Secondary	Peak exploratory flow	It measures the peak exploratory flow (PEF) in liters/second.	8 weeks
Secondary	Peak exploratory flow	It measures the peak exploratory flow (PEF) in liters/second.	6 months
Secondary	Peak exploratory flow	It measures the peak exploratory flow (PEF) in liters/second.	12 months
Secondary	Physical fitness	It was measured with six-minute walk test ,which assess the functional exercise capacity of the participants. Higher the scores represent better results and the lower scores represent worst results.	Baseline
Secondary	Physical fitness	It was measured with six-minute walk test ,which assess the functional exercise capacity of the participants. Higher the scores represent better results and the lower scores represent worst results.	8 weeks
Secondary	Physical fitness	It was measured with six-minute walk test ,which assess the functional exercise capacity of the participants. Higher the scores represent better results and the lower scores represent worst results.	6 months
Secondary	Physical fitness	It was measured with six-minute walk test ,which assess the functional exercise capacity of the participants. Higher the scores represent better results and the lower scores represent worst results.	12 months
Secondary	Health related quality of life	It was evaluated with the Short Form Health Survey-12 (SF-12). Higher the scores represent better results and the lower scores represent worst results.	Baseline
Secondary	Health related quality of life	It was evaluated with the Short Form Health Survey-12 (SF-12). Higher the scores represent better results and the lower scores represent worst results.	8 weeks
Secondary	Health related quality of life	It was evaluated with the Short Form Health Survey-12 (SF-12). Higher the scores represent better results and the lower scores represent worst results.	6 months
Secondary	Health related quality of life	It was evaluated with the Short Form Health Survey-12 (SF-12). Higher the scores represent better results and the lower scores represent worst results.	12 months