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

NCT05599893 | Completed DMC

• 1 other identifier: RHPT/021/085
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (28)

• Forced Expiratory volume 1

  Baseline

• Forced Expiratory volume 1

  8 weeks

• Forced Expiratory volume 1

  6 months

• Forced Expiratory volume 1

  12 months

• Forced vital capacity

  Baseline

Study Arms (2)

Tele - physical therapy group

EXPERIMENTAL

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

Control intervention group

ACTIVE COMPARATOR

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

Interventions

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.

Tele - physical therapy group

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.

Control intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Study Sites (1)

Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; COVID-19

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The treating therapists could not be blinded due to practical feasibility. Assessing therapists measured the outcomes of each participant at each interval without knowing the group allocation. Participants were also blinded by requesting them not to disclose their allocation to the assessing therapists and co-participants at any time during the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The participants were randomized into either of these two groups in 1:1 ratio through two block (block size 12-15) simple random sampling method. Tele - physical therapy group (TPG; n = 68) and a control intervention group (CIG; n = 68). To ensure allocation concealment, an independent therapist randomly picked up an envelope that contained patient information, in a blinded fashion and segregated the patient into either of these two groups.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: October 31, 2022
• Study Start: January 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: After publication

Locations

SA (1)