Diabetic Nephropathy Type 2NCT06332378
Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients
A study testing Experimental group 1 :Ball training and Experimental group 2 :Frenkel Exercises in people with Diabetic Nephropathy Type 2, run by Dr. Sobia Hasan at 1 site in Pakistan.
Trial summary
The goal of this Randomized control trial (clinical trial) is to learn about the effect of Exercise therapy on Type II Diabetic Neuropathic Patient in Pakistan ,40-70 year's old patient, will be refer by physicians. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Nephropathy Type 2
- What is being tested?
- Experimental group 1 :Ball training and Experimental group 2 :Frenkel Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 5 May 2024to 28 Dec 2024
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type II diabetic neuropathy
- 40-70 year's old patient, will be refer by physicians.
Who cannot join
- lower extremity complications fracture
- having experience dislocation at least six months prior to the study
- having any history of surgical operations in muscles, bones, and joints of lower extremities,
- suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report)
- knee joint flexion contracture
- interruption of the intervention sessions for more than two days
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this Randomized control trial (clinical trial) is to learn about the effect of Exercise therapy on Type II Diabetic Neuropathic Patient in Pakistan ,40-70 year's old patient, will be refer by physicians.
Exclusion criteria of the study will lower extremity complications such as fracture, having experience dislocation at least six months prior to the study, having any history of surgical operations in muscles, bones, and joints of lower extremities, suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report), knee joint flexion contracture, and interruption of the intervention sessions for more than two days..
Read more
The main question it aims to answer are:
- To compare the effects of two therapeutic exercises on clinical balance measures on type II diabetic peripheral neuropathy patients.
- Effectiveness of exercises using Swiss ball in lowering BMI.
- To assess the effectiveness of exercise interventions on fasting blood sugar (FBS) levels and glycosylated hemoglobin (HbA1c) in individuals with Type II diabetes.
- To evaluate the effectiveness of exercise interventions on autonomic nervous system activity in patients with Type II diabetic peripheral neuropathy.
- To assess the comparative effectiveness of two therapeutic exercise interventions and a control group in improving the Michigan Neuropathy Screening Instrument (MNSI) score.
By using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30).
Each exercise session contain 5 min warm-up (stationary bike), 45 min exercise training (with 1 minute rest for every 5 minutes of exercise), and 5 min of cool down activities including stretching of the muscles involved in balance exercise (gluteal, erector spine, hamstring, rectus femorus, gastro soleus, and pectoral muscles). This make the participants' heart rate stable and prepare their muscles for optimal activity.
- Conditions
- Diabetic Nephropathy Type 2
- Being tested
- Experimental group 1 :Ball training, Experimental group 2 :Frenkel Exercises, Control Group
- Keywords
- Exercise Therapy, Diabetic Neuropathies, Type 2 Diabetes Mellitus, Michigan Neuropathy Screening Instrument
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group 1 :Ball trainingOther
Ball training Training in sitting position (the participants sat on the ball and did the exercises): holding balance position on the ball, active movements (flexion, extension, abduction, adduction) of one upper extremity, active movement of two upper extremities, trunk movements (bending forward and rotation), raising heel, raising toes, raising heel and toes simultaneously, resistance against perturbation, and weight shifting on ball and 2-Training in standing position: moving the ball up and down in a straight line with two upper extremities, moving the ball up and down in an oblique line with two upper extremities, moving the ball forward and backward with left and right lower extremities, moving the ball laterally with left and right lower extremities, throwing the ball against the wall with hand, throwing the ball against the wall with foot
Experimental group 2 :Frenkel ExercisesOther
Frenkel Exercises Supine position
- Flex and extend one leg, heel sliding down a straight line on table.
- Abduct and adduct leg with knee and hip extended, leg sliding on table. Sitting position
- Place foot on therapist's hand, which will change position. 2. Raise leg and put foot on traced footprint on the wall. 3. Rise and sit with knees together. Standing position
- Place foot forward and backward on a straight line.
- Walk along a winding strip.
- Walk between two parallel lines
Control GroupOther
By using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30
| Study group | Role | What they receive |
|---|---|---|
| ball training exercise | Experimental | Not described Receives: Other: Experimental group 1 :Ball training |
| Frenkel training exercise | Experimental | Not described Receives: Other: Experimental group 2 :Frenkel Exercises |
| control group | Other | Not described Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
One Leg Stance
One Leg Stance assesses postural stability. This test includes standing on one foot without any help. This vary according to age.40-49 years-old (eyes open): 40 seconds. 50-59 years-old (eyes open): 37 seconds .
60-69 years-old (eyes open): 26.9 seconds. 70-79 years-old (eyes open): 18.3 seconds. These are normal values less than normal values indicate postural instability
Measured: 6 weeks
Berg Balance Scale
The Berg Balance Scale, is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Measured: 6 weeks
Timed Up and Go Test:
Measures the time it takes for an individual to stand up from a chair, walk three meters, turn around, walk back to the chair, and sit down. < 10 seconds = normal. < 20 seconds = good mobility; can walk outside alone; does not require a walking aid. < 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.
Measured: 6 weeks
Diabetic Neuropathy Symptom Score
Diabetic Neuropathy Symptom (DNS) score is a diabetic neuropathy screening consisting of scores from 1 to 4, and a score of ≥1 is considered significant. The severity of diabetic neuropathy was measured using an England score consisting of mild, moderate, and severe.
Measured: 6 weeks
Hemoglobin A1C
HbA1c is short for glycated Haemoglobin. The test is also sometimes called Haemoglobin A1c. Haemoglobin (Hb) is the protein in red blood cells that carries oxygen through your body. HbA1c refers to glucose and haemoglobin joined together (the haemoglobin is 'glycated').An A1c level of 7 percent is considered high and means that 7% of the hemoglobin in your blood is saturated with sugar. HbA1c (%) levels of women and men in different age groups in HbA1c <6.5 and HbA1c ≥6.5 groups.
- 30-39: 5.34
- 40-49: 5.49
- 50-59 : 5.65. A1c levels of 6.5 or greater are considered diabetes.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start5 May 2024
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Nephropathy Type 2Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Sobia Hasan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Sobia Hasan, University of Karachi
- Investigators
- Sobia Hasan, PhD*, Principal investigator, Ameen Medical centerAftab Ahmed Mirza Baig, PhD, Study director, Iqra University, North Campus, Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332378
- Sponsor's protocol ID
- sHasan
- Status last verified
- Nov 2024
- First submitted
- 17 Mar 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melese H, Alamer A, Hailu Temesgen M, Kahsay G. Effectiveness of Exercise Therapy on Gait Function in Diabetic Peripheral Neuropathy Patients: A Systematic Review of Randomized Controlled Trials. Diabetes Metab Syndr Obes. 2020 Aug 5;13:2753-2764. doi: 10.2147/DMSO.S261175. eCollection 2020.
PubMed 32848436Francia P, De Bellis A, Iannone G, Sinopoli R, Bocchi L, Anichini R. The Role of New Technological Opportunities and the Need to Evaluate the Activities Performed in the Prevention of Diabetic Foot with Exercise Therapy. Medicines (Basel). 2021 Dec 2;8(12):76. doi: 10.3390/medicines8120076.
PubMed 34940288
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients
- ClinicalTrials.gov ID
- NCT06332378
- Acronym / sponsor ID
- sHasan
- Conditions
- Diabetic Nephropathy Type 2
- Keywords
- Exercise Therapy, Diabetic Neuropathies, Type 2 Diabetes Mellitus, Michigan Neuropathy Screening Instrument
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dr. Sobia HasanUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 27 Mar 2024 (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.
The goal of this Randomized control trial (clinical trial) is to learn about the effect of Exercise therapy on Type II Diabetic Neuropathic Patient in Pakistan ,40-70 year's old patient, will be refer by physicians.
Exclusion criteria of the study will lower extremity complications such as fracture, having experience dislocation at least six months prior to the study, having any history of surgical operations in muscles, bones, and joints of lower extremities, suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report), knee joint flexion contracture, and interruption of the intervention sessions for more than two days..
The main question it aims to answer are:
- To compare the effects of two therapeutic exercises on clinical balance measures on type II diabetic peripheral neuropathy patients.
- Effectiveness of exercises using Swiss ball in lowering BMI.
- To assess the effectiveness of exercise interventions on fasting blood sugar (FBS) levels and glycosylated hemoglobin (HbA1c) in individuals with Type II diabetes.
- To evaluate the effectiveness of exercise interventions on autonomic nervous system activity in patients with Type II diabetic peripheral neuropathy.
- To assess the comparative effectiveness of two therapeutic exercise interventions and a control group in improving the Michigan Neuropathy Screening Instrument (MNSI) score.
By using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30).
Each exercise session contain 5 min warm-up (stationary bike), 45 min exercise training (with 1 minute rest for every 5 minutes of exercise), and 5 min of cool down activities including stretching of the muscles involved in balance exercise (gluteal, erector spine, hamstring, rectus femorus, gastro soleus, and pectoral muscles). This make the participants' heart rate stable and prepare their muscles for optimal activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ball training exercise | Experimental | Other: Experimental group 1 :Ball training |
| Frenkel training exercise | Experimental | Other: Experimental group 2 :Frenkel Exercises |
| control group | Other | Other: Control Group |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with type II diabetic neuropathy
- 40-70 year's old patient, will be refer by physicians.
Key exclusion criteria (6 listed)
- lower extremity complications fracture
- having experience dislocation at least six months prior to the study
- having any history of surgical operations in muscles, bones, and joints of lower extremities,
- suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report)
- knee joint flexion contracture
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 |
|---|---|---|
| Experimental group 1 :Ball trainingBall training Training in sitting position (the participants sat on the ball and did the exercises): holding balance position on the ball, active movements (flexion, extension, abduction, adduction) of one upper extremity, active movement of two upper extremities, trunk movements (bending forward and rotation), raising heel, raising toes, raising heel and toes simultaneously, resistance against perturbation, and weight shifting on ball and 2-Training in standing position: moving the ball up and down in a straight line with two upper extremities, moving the ball up and down in an oblique line with two upper extremities, moving the ball forward and backward with left and right lower extremities, moving the ball laterally with left and right lower extremities, throwing the ball against the wall with hand, throwing the ball against the wall with foot | Other | ball training exercise |
| Experimental group 2 :Frenkel ExercisesFrenkel Exercises Supine position 1. Flex and extend one leg, heel sliding down a straight line on table. 2. Abduct and adduct leg with knee and hip extended, leg sliding on table. Sitting position 1. Place foot on therapist's hand, which will change position. 2. Raise leg and put foot on traced footprint on the wall. 3. Rise and sit with knees together. Standing position 1. Place foot forward and backward on a straight line. 2. Walk along a winding strip. 3. Walk between two parallel lines | Other | Frenkel training exercise |
| Control GroupBy using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30 | Other | control group |
Primary outcome
One Leg Stance
Time frame: 6 weeks
One Leg Stance assesses postural stability. This test includes standing on one foot without any help. This vary according to age.40-49 years-old (eyes open): 40 seconds. 50-59 years-old (eyes open): 37 seconds . 60-69 years-old (eyes open): 26.9 seconds. 70-79 years-old (eyes open): 18.3 seconds. These are normal values less than normal values indicate postural instability
Berg Balance Scale
Time frame: 6 weeks
The Berg Balance Scale, is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Timed Up and Go Test:
Time frame: 6 weeks
Measures the time it takes for an individual to stand up from a chair, walk three meters, turn around, walk back to the chair, and sit down. < 10 seconds = normal. < 20 seconds = good mobility; can walk outside alone; does not require a walking aid. < 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.
Diabetic Neuropathy Symptom Score
Time frame: 6 weeks
Diabetic Neuropathy Symptom (DNS) score is a diabetic neuropathy screening consisting of scores from 1 to 4, and a score of ≥1 is considered significant. The severity of diabetic neuropathy was measured using an England score consisting of mild, moderate, and severe.
Hemoglobin A1C
Time frame: 8 weeks
HbA1c is short for glycated Haemoglobin. The test is also sometimes called Haemoglobin A1c. Haemoglobin (Hb) is the protein in red blood cells that carries oxygen through your body. HbA1c refers to glucose and haemoglobin joined together (the haemoglobin is 'glycated').An A1c level of 7 percent is considered high and means that 7% of the hemoglobin in your blood is saturated with sugar. HbA1c (%) levels of women and men in different age groups in HbA1c <6.5 and HbA1c ≥6.5 groups. 1. 30-39: 5.34 2. 40-49: 5.49 3. 50-59 : 5.65. A1c levels of 6.5 or greater are considered diabetes.
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 31 Dec 2024.
- Results publication: PubMed 32848436Melese H, Alamer A, Hailu Temesgen M, Kahsay G. Effectiveness of Exercise Therapy on Gait Function in Diabetic Peripheral Neuropathy Patients: A Systematic Review of Randomized Controlled Trials. Diabetes Metab Syndr Obes. 2020 Aug 5;13:2753-2764. doi: 10.2147/DMSO.S261175. eCollection 2020.
- Results publication: PubMed 34940288Francia P, De Bellis A, Iannone G, Sinopoli R, Bocchi L, Anichini R. The Role of New Technological Opportunities and the Need to Evaluate the Activities Performed in the Prevention of Diabetic Foot with Exercise Therapy. Medicines (Basel). 2021 Dec 2;8(12):76. doi: 10.3390/medicines8120076.
- Individual participant dataSharing planned: No
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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.
Sobia Hasan, PhD* principal investigator
Ameen Medical center
Aftab Ahmed Mirza Baig, PhD study director
Iqra University, North Campus, Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group 1 :Ball training and Experimental group 2 :Frenkel Exercises in people with Diabetic Nephropathy Type 2, run by Dr. Sobia Hasan at 1 site in Pakistan.
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 2 inclusion and 6 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 31 Dec 2024. 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 Pakistan. 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?
One Leg Stance (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06332378, which also lists 2 linked publications.
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 31 Dec 2024.