Type 2 Diabetes MellitusNCT05599893
Role of Tele-physical Therapy in Patients With Type 2 Diabetes Mellitus Following COVID-19 Infection.
A study testing Tele physical therapy and Patient educationa and Conventional exercises in people with Type 2 Diabetes Mellitus and COVID-19, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, COVID-19
- What is being tested?
- Tele physical therapy and Patient educationa and Conventional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Tele physical therapy, Patient educationa and Conventional exercises
- Medical subject headings
- Diabetes Mellitus, Type 2, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele physical therapyOther
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 exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Patient educationa and Conventional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (28)
Forced Expiratory volume 1
It measures the forced expiratory volume in the first second (FEV1) in litres
Measured: Baseline
Forced Expiratory volume 1
It measures the forced expiratory volume in the first second (FEV1) in litres
Measured: 8 weeks
Forced Expiratory volume 1
It measures the forced expiratory volume in the first second (FEV1) in litres
Measured: 6 months
Forced Expiratory volume 1
It measures the forced expiratory volume in the first second (FEV1) in litres
Measured: 12 months
Forced vital capacity
It measures the forced vital capacity (FVC) in litres.
Measured: Baseline
Forced vital capacity
It measures the forced vital capacity (FVC) in litres.
Measured: 8 weeks
Forced vital capacity
It measures the forced vital capacity (FVC) in litres.
Measured: 6 months
Forced vital capacity
It measures the forced vital capacity (FVC) in litres.
Measured: 12 months
Forced vital capacity/Forced Expiratory volume 1
It measures the forced expiratory volume1/forced vital capacity in percentage.
Measured: Baseline
Forced vital capacity/Forced Expiratory volume 1
It measures the forced expiratory volume1/forced vital capacity in percentage.
Measured: 8 weeks
Forced vital capacity/Forced Expiratory volume 1
It measures the forced expiratory volume1/forced vital capacity in percentage.
Measured: 6 months
Forced vital capacity/Forced Expiratory volume 1
It measures the forced expiratory volume1/forced vital capacity in percentage.
Measured: 12 months
Maximum voluntary ventilation
It measures the maximum voluntary ventilation (MVV) in liters/minute.
Measured: Baseline
Maximum voluntary ventilation
It measures the maximum voluntary ventilation (MVV) in liters/minute.
Measured: 8 weeks
Maximum voluntary ventilation
It measures the maximum voluntary ventilation (MVV) in liters/minute.
Measured: 6 months
Maximum voluntary ventilation
It measures the maximum voluntary ventilation (MVV) in liters/minute.
Measured: 12 months
Peak exploratory flow
It measures the peak exploratory flow (PEF) in liters/second.
Measured: Baseline
Peak exploratory flow
It measures the peak exploratory flow (PEF) in liters/second.
Measured: 8 weeks
Peak exploratory flow
It measures the peak exploratory flow (PEF) in liters/second.
Measured: 6 months
Peak exploratory flow
It measures the peak exploratory flow (PEF) in liters/second.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Jan 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gopal Nambi, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599893
- Sponsor's protocol ID
- RHPT/021/085
- Status last verified
- Oct 2022
- First submitted
- 28 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05599893
- Acronym / sponsor ID
- RHPT/021/085
- Conditions
- Type 2 Diabetes Mellitus, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tele - physical therapy group | Experimental | Other: Tele physical therapyParticipants 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. |
| Control intervention group | Active comparator | Other: Patient educationa and Conventional exercisesDuring 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele physical therapyBefore 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. | Other | Tele - physical therapy group |
| Patient educationa and Conventional exercisesThey 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. | Other | Control intervention group |
Primary outcome
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.
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.
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.
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.
28 secondary outcomes
Forced Expiratory volume 1
Time frame: Baseline
Forced Expiratory volume 1
Time frame: 8 weeks
Forced Expiratory volume 1
Time frame: 6 months
Forced Expiratory volume 1
Time frame: 12 months
Forced vital capacity
Time frame: Baseline
Forced vital capacity
Time frame: 8 weeks
Forced vital capacity
Time frame: 6 months
Forced vital capacity
Time frame: 12 months
Forced vital capacity/Forced Expiratory volume 1
Time frame: Baseline
Forced vital capacity/Forced Expiratory volume 1
Time frame: 8 weeks
Forced vital capacity/Forced Expiratory volume 1
Time frame: 6 months
Forced vital capacity/Forced Expiratory volume 1
Time frame: 12 months
Maximum voluntary ventilation
Time frame: Baseline
Maximum voluntary ventilation
Time frame: 8 weeks
Maximum voluntary ventilation
Time frame: 6 months
Maximum voluntary ventilation
Time frame: 12 months
Peak exploratory flow
Time frame: Baseline
Peak exploratory flow
Time frame: 8 weeks
Peak exploratory flow
Time frame: 6 months
Peak exploratory flow
Time frame: 12 months
Physical fitness
Time frame: Baseline
Physical fitness
Time frame: 8 weeks
Physical fitness
Time frame: 6 months
Physical fitness
Time frame: 12 months
Health related quality of life
Time frame: Baseline
Health related quality of life
Time frame: 8 weeks
Health related quality of life
Time frame: 6 months
Health related quality of life
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele physical therapy and Patient educationa and Conventional exercises in people with Type 2 Diabetes Mellitus and COVID-19, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic level (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.