Diabetic Peripheral NeuropathyNCT06262074
Effect of Structured Training Program in Diabetic Patients
A study testing Structured Exercise Program and Non structured exercise program in people with Diabetic Peripheral Neuropathy, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
Trial summary
Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Structured Exercise Program and Non structured exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 8 Feb 2024to 31 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diabetes mellitus with moderate to severe DPN
- Subjects of both gender
- Age from 40 to 70 years
- Independent walking
- MNSI score more than 2 out of 13
Who cannot join
- Presence of an active planter ulcer
- History of surgery during intervention period
- Neurological diseases other than DPN
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
MMIPR
Ambāla, Haryana, 133207
Subhashish Chatterjee, MPT(NEURO), +918950037407, subhasishphysio@gmail.com
Subhashish Chatterjee, MPT
About this study
Official title: Effect of Structured Training Program on Functional Abilities in Patients With Diabetic Neuropathy
Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. In such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals.
Read the detailed description
The goal of this type of interventional study is to assess the effect a well-defined exercise program for individuals with DPN, despite the existence of various individualized exercise programs designed for DPN patients. The main questions this study aims to answer is:
What is the effect of a 4-weeks structured training program as an adjunct to general lower limb exercise in patients with DPN on pain, sensory symptoms, balance, vibration sense and Quality of life?
Group 1:
Patients in group 1 will receive a structured exercise program.
Group 2:
Patients in group 2 will receive a non-structured exercise program. This group will allow us to compare the effects of a structured and a non-structured exercise program.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Structured Exercise Program, Non structured exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Exercise ProgramOther
30 minutes of structured exercise programs
Non structured exercise programOther
Non structured exercises
| Study group | Role | What they receive |
|---|---|---|
| Group-1 (Structured Exercise Program) | Experimental | Patients undergo structured exercise sessions lasting 30 minutes, encompassing activities such as range of motion, flexibility exercises, strength training, balance exercises, and aerobic exercises, with designated intervals between each session. Receives: Other: Structured Exercise Program |
| Group-2 (Non-Structured Exercise Program) | Other | Patients are provided with a simple exercise routine that lacks a structured format. Receives: Other: Non structured exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan neuropathy screening instrument (MNSI)
The scale consists of two parts: the first part involves a patient history assessment, while the second part focuses on physical examination. This scale is considered both reliable and practical for evaluating the severity of neuropathy. If the patient's score increases, it indicates a higher severity of the disease, whereas if the score decreases, it suggests a lower severity.
Measured: The measurement will be taken during the baseline assessment and again after the completion of treatment.
Biothesiometer
This objective measure is utilized to assess the vibratory pressure threshold in affected areas. It possesses the capability to detect various frequencies for vibratory pressure threshold assessment. It is regarded as a practical tool for evaluating both superficial and vibratory sensations. If there is an increased perception of frequency, it indicates that the vibratory pressure threshold is more severely affected.
Measured: The measurement will be taken during the baseline assessment and again after the completion of treatment.
NeuroQoL
The Neuropathy-and Foot-Ulcer Specific Quality of Life Instrument is designed as a Likert scale and serves as a reliable method for assessing quality of life related to neuropathy. If the scoring indicates a higher value, it suggests that the disease is more severe.
Measured: The measurement will be taken during the baseline assessment and again after the completion of treatment.
Secondary outcomes (1)
NPRS
The Numeric Pain Rating Scale, ranging from 0 to 10, is employed as a subjective assessment tool to measure an individual's pain perception. In general, higher scores on the scale indicate a greater severity of pain linked to the disease.
Measured: The measurement will be taken during the baseline assessment and again after the completion of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start8 Feb 2024
- Primary completion8 Feb 2024
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies 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
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhasish Chatterjee, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Khushboo Kumari, BPT, (MPT), Principal investigator, Maharishi Markandeshwar Instirtute of Physiotherapy and Rehabilitation, Ambala, Haryana, 133207
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262074
- Sponsor's protocol ID
- IEC-2418
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Structured Training Program on Functional Abilities in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT06262074
- Acronym / sponsor ID
- IEC-2418
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 15 Feb 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.
Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. In such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals.
Detailed description
The goal of this type of interventional study is to assess the effect a well-defined exercise program for individuals with DPN, despite the existence of various individualized exercise programs designed for DPN patients. The main questions this study aims to answer is:
What is the effect of a 4-weeks structured training program as an adjunct to general lower limb exercise in patients with DPN on pain, sensory symptoms, balance, vibration sense and Quality of life?
Group 1:
Patients in group 1 will receive a structured exercise program.
Group 2:
Patients in group 2 will receive a non-structured exercise program. This group will allow us to compare the effects of a structured and a non-structured exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-1 (Structured Exercise Program) | Experimental | Other: Structured Exercise ProgramPatients undergo structured exercise sessions lasting 30 minutes, encompassing activities such as range of motion, flexibility exercises, strength training, balance exercises, and aerobic exercises, with designated intervals between each session. |
| Group-2 (Non-Structured Exercise Program) | Other | Other: Non structured exercise programPatients are provided with a simple exercise routine that lacks a structured format. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes mellitus with moderate to severe DPN
- Subjects of both gender
- Age from 40 to 70 years
- Independent walking
- MNSI score more than 2 out of 13
Key exclusion criteria (3 listed)
- Presence of an active planter ulcer
- History of surgery during intervention period
- Neurological diseases other than DPN
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 |
|---|---|---|
| Structured Exercise Program30 minutes of structured exercise programs | Other | Group-1 (Structured Exercise Program) |
| Non structured exercise programNon structured exercises | Other | Group-2 (Non-Structured Exercise Program) |
Primary outcome
Michigan neuropathy screening instrument (MNSI)
Time frame: The measurement will be taken during the baseline assessment and again after the completion of treatment.
The scale consists of two parts: the first part involves a patient history assessment, while the second part focuses on physical examination. This scale is considered both reliable and practical for evaluating the severity of neuropathy. If the patient's score increases, it indicates a higher severity of the disease, whereas if the score decreases, it suggests a lower severity.
Biothesiometer
Time frame: The measurement will be taken during the baseline assessment and again after the completion of treatment.
This objective measure is utilized to assess the vibratory pressure threshold in affected areas. It possesses the capability to detect various frequencies for vibratory pressure threshold assessment. It is regarded as a practical tool for evaluating both superficial and vibratory sensations. If there is an increased perception of frequency, it indicates that the vibratory pressure threshold is more severely affected.
NeuroQoL
Time frame: The measurement will be taken during the baseline assessment and again after the completion of treatment.
The Neuropathy-and Foot-Ulcer Specific Quality of Life Instrument is designed as a Likert scale and serves as a reliable method for assessing quality of life related to neuropathy. If the scoring indicates a higher value, it suggests that the disease is more severe.
1 secondary outcome
NPRS
Time frame: The measurement will be taken during the baseline assessment and again after the completion of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- 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.
Khushboo Kumari, BPT, (MPT) principal investigator
Maharishi Markandeshwar Instirtute of Physiotherapy and Rehabilitation, Ambala, Haryana, 133207
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Exercise Program and Non structured exercise program in people with Diabetic Peripheral Neuropathy, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Subhasish Chatterjee, PhD (8708660994, subhasishphysio@mmumullana.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Michigan neuropathy screening instrument (MNSI) (time frame: The measurement will be taken during the baseline assessment and again after the completion of treatment.). The study lists 3 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 15 Feb 2024.