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

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.

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Tele physical therapy; Other: Patient educationa and Conventional exercises

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al Kharj, Riyadh, Saudi Arabia, 11942
      • Gopal Nambi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory volume 1	It measures the forced expiratory volume in the first second (FEV1) in litres	Baseline
Forced Expiratory volume 1	It measures the forced expiratory volume in the first second (FEV1) in litres	8 weeks
Forced Expiratory volume 1	It measures the forced expiratory volume in the first second (FEV1) in litres	6 months
Forced Expiratory volume 1	It measures the forced expiratory volume in the first second (FEV1) in litres	12 months
Forced vital capacity	It measures the forced vital capacity (FVC) in litres.	Baseline
Forced vital capacity	It measures the forced vital capacity (FVC) in litres.	8 weeks
Forced vital capacity	It measures the forced vital capacity (FVC) in litres.	6 months
Forced vital capacity	It measures the forced vital capacity (FVC) in litres.	12 months
Forced vital capacity/Forced Expiratory volume 1	It measures the forced expiratory volume1/forced vital capacity in percentage.	Baseline
Forced vital capacity/Forced Expiratory volume 1	It measures the forced expiratory volume1/forced vital capacity in percentage.	8 weeks
Forced vital capacity/Forced Expiratory volume 1	It measures the forced expiratory volume1/forced vital capacity in percentage.	6 months
Forced vital capacity/Forced Expiratory volume 1	It measures the forced expiratory volume1/forced vital capacity in percentage.	12 months
Maximum voluntary ventilation	It measures the maximum voluntary ventilation (MVV) in liters/minute.	Baseline
Maximum voluntary ventilation	It measures the maximum voluntary ventilation (MVV) in liters/minute.	8 weeks
Maximum voluntary ventilation	It measures the maximum voluntary ventilation (MVV) in liters/minute.	6 months
Maximum voluntary ventilation	It measures the maximum voluntary ventilation (MVV) in liters/minute.	12 months
Peak exploratory flow	It measures the peak exploratory flow (PEF) in liters/second.	Baseline
Peak exploratory flow	It measures the peak exploratory flow (PEF) in liters/second.	8 weeks
Peak exploratory flow	It measures the peak exploratory flow (PEF) in liters/second.	6 months
Peak exploratory flow	It measures the peak exploratory flow (PEF) in liters/second.	12 months
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Prince Sattam Bin Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 29, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Endocrine System Diseases; COVID-19; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RHPT/021/085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: After publication
• IPD Sharing Supporting Information Type: Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No