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

Primary Purpose

Type 2 Diabetes Mellitus, COVID-19

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Tele physical therapy
Patient educationa and Conventional exercises
Sponsored by
Prince Sattam Bin Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gopal Nambi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tele - physical therapy group

Control intervention group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Forced Expiratory volume 1
It measures the forced expiratory volume in the first second (FEV1) in litres
Forced Expiratory volume 1
It measures the forced expiratory volume in the first second (FEV1) in litres
Forced Expiratory volume 1
It measures the forced expiratory volume in the first second (FEV1) in litres
Forced Expiratory volume 1
It measures the forced expiratory volume in the first second (FEV1) in litres
Forced vital capacity
It measures the forced vital capacity (FVC) in litres.
Forced vital capacity
It measures the forced vital capacity (FVC) in litres.
Forced vital capacity
It measures the forced vital capacity (FVC) in litres.
Forced vital capacity
It measures the forced vital capacity (FVC) in litres.
Forced vital capacity/Forced Expiratory volume 1
It measures the forced expiratory volume1/forced vital capacity in percentage.
Forced vital capacity/Forced Expiratory volume 1
It measures the forced expiratory volume1/forced vital capacity in percentage.
Forced vital capacity/Forced Expiratory volume 1
It measures the forced expiratory volume1/forced vital capacity in percentage.
Forced vital capacity/Forced Expiratory volume 1
It measures the forced expiratory volume1/forced vital capacity in percentage.
Maximum voluntary ventilation
It measures the maximum voluntary ventilation (MVV) in liters/minute.
Maximum voluntary ventilation
It measures the maximum voluntary ventilation (MVV) in liters/minute.
Maximum voluntary ventilation
It measures the maximum voluntary ventilation (MVV) in liters/minute.
Maximum voluntary ventilation
It measures the maximum voluntary ventilation (MVV) in liters/minute.
Peak exploratory flow
It measures the peak exploratory flow (PEF) in liters/second.
Peak exploratory flow
It measures the peak exploratory flow (PEF) in liters/second.
Peak exploratory flow
It measures the peak exploratory flow (PEF) in liters/second.
Peak exploratory flow
It measures the peak exploratory flow (PEF) in liters/second.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 28, 2022
Last Updated
October 29, 2022
Sponsor
Prince Sattam Bin Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT05599893
Brief Title
Role of Tele-physical Therapy in Patients With Type 2 Diabetes Mellitus Following COVID-19 Infection.
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince Sattam Bin Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tele - physical therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control intervention group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tele physical therapy
Intervention Description
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
Intervention Name(s)
Patient educationa and Conventional exercises
Intervention Description
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 Outcome Measure Information:
Title
Glycemic level
Description
The hemoglobin A1C test, also known as HbA1c test. It is a simple blood test which measures the blood sugar levels of the participants.
Time Frame
Baseline
Title
Glycemic level
Description
The hemoglobin A1C test, also known as HbA1c test. It is a simple blood test which measures the blood sugar levels of the participants.
Time Frame
8 weeks
Title
Glycemic level
Description
The hemoglobin A1C test, also known as HbA1c test. It is a simple blood test which measures the blood sugar levels of the participants.
Time Frame
6 months
Title
Glycemic level
Description
The hemoglobin A1C test, also known as HbA1c test. It is a simple blood test which measures the blood sugar levels of the participants.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Forced Expiratory volume 1
Description
It measures the forced expiratory volume in the first second (FEV1) in litres
Time Frame
Baseline
Title
Forced Expiratory volume 1
Description
It measures the forced expiratory volume in the first second (FEV1) in litres
Time Frame
8 weeks
Title
Forced Expiratory volume 1
Description
It measures the forced expiratory volume in the first second (FEV1) in litres
Time Frame
6 months
Title
Forced Expiratory volume 1
Description
It measures the forced expiratory volume in the first second (FEV1) in litres
Time Frame
12 months
Title
Forced vital capacity
Description
It measures the forced vital capacity (FVC) in litres.
Time Frame
Baseline
Title
Forced vital capacity
Description
It measures the forced vital capacity (FVC) in litres.
Time Frame
8 weeks
Title
Forced vital capacity
Description
It measures the forced vital capacity (FVC) in litres.
Time Frame
6 months
Title
Forced vital capacity
Description
It measures the forced vital capacity (FVC) in litres.
Time Frame
12 months
Title
Forced vital capacity/Forced Expiratory volume 1
Description
It measures the forced expiratory volume1/forced vital capacity in percentage.
Time Frame
Baseline
Title
Forced vital capacity/Forced Expiratory volume 1
Description
It measures the forced expiratory volume1/forced vital capacity in percentage.
Time Frame
8 weeks
Title
Forced vital capacity/Forced Expiratory volume 1
Description
It measures the forced expiratory volume1/forced vital capacity in percentage.
Time Frame
6 months
Title
Forced vital capacity/Forced Expiratory volume 1
Description
It measures the forced expiratory volume1/forced vital capacity in percentage.
Time Frame
12 months
Title
Maximum voluntary ventilation
Description
It measures the maximum voluntary ventilation (MVV) in liters/minute.
Time Frame
Baseline
Title
Maximum voluntary ventilation
Description
It measures the maximum voluntary ventilation (MVV) in liters/minute.
Time Frame
8 weeks
Title
Maximum voluntary ventilation
Description
It measures the maximum voluntary ventilation (MVV) in liters/minute.
Time Frame
6 months
Title
Maximum voluntary ventilation
Description
It measures the maximum voluntary ventilation (MVV) in liters/minute.
Time Frame
12 months
Title
Peak exploratory flow
Description
It measures the peak exploratory flow (PEF) in liters/second.
Time Frame
Baseline
Title
Peak exploratory flow
Description
It measures the peak exploratory flow (PEF) in liters/second.
Time Frame
8 weeks
Title
Peak exploratory flow
Description
It measures the peak exploratory flow (PEF) in liters/second.
Time Frame
6 months
Title
Peak exploratory flow
Description
It measures the peak exploratory flow (PEF) in liters/second.
Time Frame
12 months
Title
Physical fitness
Description
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.
Time Frame
Baseline
Title
Physical fitness
Description
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.
Time Frame
8 weeks
Title
Physical fitness
Description
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.
Time Frame
6 months
Title
Physical fitness
Description
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.
Time Frame
12 months
Title
Health related quality of life
Description
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.
Time Frame
Baseline
Title
Health related quality of life
Description
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.
Time Frame
8 weeks
Title
Health related quality of life
Description
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.
Time Frame
6 months
Title
Health related quality of life
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Gopal Nambi
City
Al Kharj
State/Province
Riyadh
ZIP/Postal Code
11942
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
After publication

Learn more about this trial

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

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