Clinical trial NCT05599893: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
COVID-19
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Glycemic level
timeFrame: Baseline
measure: Glycemic level
timeFrame: 8 weeks
measure: Glycemic level
timeFrame: 6 months
measure: Glycemic level
timeFrame: 12 months
Secondary outcomes:
measure: Forced Expiratory volume 1
timeFrame: Baseline
measure: Forced Expiratory volume 1
timeFrame: 8 weeks
measure: Forced Expiratory volume 1
timeFrame: 6 months
measure: Forced Expiratory volume 1
timeFrame: 12 months
measure: Forced vital capacity
timeFrame: Baseline
measure: Forced vital capacity
timeFrame: 8 weeks
measure: Forced vital capacity
timeFrame: 6 months
measure: Forced vital capacity
timeFrame: 12 months
measure: Forced vital capacity/Forced Expiratory volume 1
timeFrame: Baseline
measure: Forced vital capacity/Forced Expiratory volume 1
timeFrame: 8 weeks
measure: Forced vital capacity/Forced Expiratory volume 1
timeFrame: 6 months
measure: Forced vital capacity/Forced Expiratory volume 1
timeFrame: 12 months
measure: Maximum voluntary ventilation
timeFrame: Baseline
measure: Maximum voluntary ventilation
timeFrame: 8 weeks
measure: Maximum voluntary ventilation
timeFrame: 6 months
measure: Maximum voluntary ventilation
timeFrame: 12 months
measure: Peak exploratory flow
timeFrame: Baseline
measure: Peak exploratory flow
timeFrame: 8 weeks
measure: Peak exploratory flow
timeFrame: 6 months
measure: Peak exploratory flow
timeFrame: 12 months
measure: Physical fitness
timeFrame: Baseline
measure: Physical fitness
timeFrame: 8 weeks
measure: Physical fitness
timeFrame: 6 months
measure: Physical fitness
timeFrame: 12 months
measure: Health related quality of life
timeFrame: Baseline
measure: Health related quality of life
timeFrame: 8 weeks
measure: Health related quality of life
timeFrame: 6 months
measure: Health related quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Gopal Nambi
state: Riyadh
Study officials:
References: