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

NCT ID: NCT05599893

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-09-30

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.

Conditions

Type 2 Diabetes Mellitus; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tele - physical therapy group

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.

Group Type: EXPERIMENTAL

Tele physical therapy

Intervention Type: OTHER

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.

Control intervention group

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.

Group Type: ACTIVE_COMPARATOR

Patient educationa and Conventional exercises

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince Sattam Bin Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Gopal Nambi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gopal Nambi

Al Kharj, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

RHPT/021/085

Identifier Type: -

Identifier Source: org_study_id