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Completed

NCT Number: NCT05599893

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus COVID-19 Coronaviridae Infections Coronavirus Infections Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Infections Lung Diseases Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tele physical therapy

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.

Patient educationa and Conventional exercises

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.

Primary outcomes

  1. Glycemic level

    Time frame: Baseline

    The hemoglobin A1C test, also known as HbA1c test. It is a simple blood test which measures the blood sugar levels of the participants.

  2. Glycemic level

    Time frame: 8 weeks

    The hemoglobin A1C test, also known as HbA1c test. It is a simple blood test which measures the blood sugar levels of the participants.

  3. Glycemic level

    Time frame: 6 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.

  4. Glycemic level

    Time frame: 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 outcomes

  1. Forced Expiratory volume 1

    Time frame: Baseline

    It measures the forced expiratory volume in the first second (FEV1) in litres

  2. Forced Expiratory volume 1

    Time frame: 8 weeks

    It measures the forced expiratory volume in the first second (FEV1) in litres

  3. Forced Expiratory volume 1

    Time frame: 6 months

    It measures the forced expiratory volume in the first second (FEV1) in litres

  4. Forced Expiratory volume 1

    Time frame: 12 months

    It measures the forced expiratory volume in the first second (FEV1) in litres

  5. Forced vital capacity

    Time frame: Baseline

    It measures the forced vital capacity (FVC) in litres.

  6. Forced vital capacity

    Time frame: 8 weeks

    It measures the forced vital capacity (FVC) in litres.

  7. Forced vital capacity

    Time frame: 6 months

    It measures the forced vital capacity (FVC) in litres.

  8. Forced vital capacity

    Time frame: 12 months

    It measures the forced vital capacity (FVC) in litres.

  9. Forced vital capacity/Forced Expiratory volume 1

    Time frame: Baseline

    It measures the forced expiratory volume1/forced vital capacity in percentage.

  10. Forced vital capacity/Forced Expiratory volume 1

    Time frame: 8 weeks

    It measures the forced expiratory volume1/forced vital capacity in percentage.

  11. Forced vital capacity/Forced Expiratory volume 1

    Time frame: 6 months

    It measures the forced expiratory volume1/forced vital capacity in percentage.

  12. Forced vital capacity/Forced Expiratory volume 1

    Time frame: 12 months

    It measures the forced expiratory volume1/forced vital capacity in percentage.

  13. Maximum voluntary ventilation

    Time frame: Baseline

    It measures the maximum voluntary ventilation (MVV) in liters/minute.

  14. Maximum voluntary ventilation

    Time frame: 8 weeks

    It measures the maximum voluntary ventilation (MVV) in liters/minute.

  15. Maximum voluntary ventilation

    Time frame: 6 months

    It measures the maximum voluntary ventilation (MVV) in liters/minute.

  16. Maximum voluntary ventilation

    Time frame: 12 months

    It measures the maximum voluntary ventilation (MVV) in liters/minute.

  17. Peak exploratory flow

    Time frame: Baseline

    It measures the peak exploratory flow (PEF) in liters/second.

  18. Peak exploratory flow

    Time frame: 8 weeks

    It measures the peak exploratory flow (PEF) in liters/second.

  19. Peak exploratory flow

    Time frame: 6 months

    It measures the peak exploratory flow (PEF) in liters/second.

  20. Peak exploratory flow

    Time frame: 12 months

    It measures the peak exploratory flow (PEF) in liters/second.

  21. Physical fitness

    Time frame: Baseline

    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.

  22. Physical fitness

    Time frame: 8 weeks

    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.

  23. Physical fitness

    Time frame: 6 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.

  24. Physical fitness

    Time frame: 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.

  25. Health related quality of life

    Time frame: Baseline

    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.

  26. Health related quality of life

    Time frame: 8 weeks

    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.

  27. Health related quality of life

    Time frame: 6 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.

  28. Health related quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Prince Sattam Bin Abdulaziz University

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2022
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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