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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; COVID-19
• Interventions: Other: Patient educationa and Conventional exercises; Other: Tele physical therapy

• Registration Number: NCT05599893
• Lead Sponsor: Prince Sattam Bin Abdulaziz University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-10-28
• Last Update Submitted: 2022-10-29
• Study First Posted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control intervention group	Patient educationa and Conventional exercises	During the first visit, participants in the control intervention group (CIG) received patient education for 10 minutes from physical therapists and also received a pamphlet containing these instructions in written form. They were informed to do their normal daily activities, avoid sedentary lifestyle, perform regular physical activities such as household activities, maintain balance diet and have 6-8 hours of sleep per day.
Tele - physical therapy group	Tele physical therapy	Participants in the tele-physical therapy group underwent tele-physical therapy sessions which includes an internet-based video conference under the supervision of physical therapists. 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 a cool-down phase. The participants in the tele physical therapy group received training four times a week, for 8 weeks, each session lasted for 60 minutes.

Primary Outcome Measures

Name	Time	Method
Glycemic level	12 months	The hemoglobin A1C test, also known as HbA1c test. It is a simple blood test which measures the blood sugar levels of the participants.

Secondary Outcome Measures

Name	Time	Method
Forced vital capacity/Forced Expiratory volume 1	12 months	It measures the forced expiratory volume1/forced vital capacity in percentage.
Forced vital capacity	12 months	It measures the forced vital capacity (FVC) in litres.
Physical fitness	12 months	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.
Peak exploratory flow	12 months	It measures the peak exploratory flow (PEF) in liters/second.
Forced Expiratory volume 1	12 months	It measures the forced expiratory volume in the first second (FEV1) in litres
Maximum voluntary ventilation	12 months	It measures the maximum voluntary ventilation (MVV) in liters/minute.
Health related quality of life	12 months	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.

Trial Locations

Locations (1)

Gopal Nambi; 🇸🇦 Al Kharj, Riyadh, Saudi Arabia