Peripheral Diabetic NeuropathyNCT05491850
Effects of Moderate Physical Activity on Early Symptoms of Peripheral Diabetic Neuropathy in Type-II Diabetes: A Randomized Clinical Trial
A study testing Moderate Physical Activity for Peripheral Diabetic Neuropathy in people with Peripheral Diabetic Neuropathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study determines the effects of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes. Most of the literature shows the impact of physical activity to manage/controlling diabetes. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Peripheral Diabetic Neuropathy
- What is being tested?
- Moderate Physical Activity for Peripheral Diabetic Neuropathy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2021to 25 Dec 2021
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type-II Diabetes
- Diagnosed cases of Peripheral Diabetic Neuropathy
- Peripheral Diabetic Neuropathy Stage 1 \& 2
- Numbness or reduced ability to feel pain or temperature changes.
- Tingling or burning sensation.
- Sharp pains or cramps.
Show all 12Show fewer
- Increased sensitivity to touch
- Males and females
- Age: 35-65
- HbA1c above 6.5
- Mild activity level on IPAQ-7 (< 150min/per week)
- Berg Balance Scale score (< 45)
Who cannot join
- Cardiac Issues
- Any neurological issue
- Lower limb deformity
- Acute injury
- Hip and Knee OA
- Patients with walking difficulty
- Diabetic foot
Trial locations and contacts
1 site in 1 country.
About this study
This study determines the effects of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes. Most of the literature shows the impact of physical activity to manage/controlling diabetes. Some studies were conducted on animals to study the impact of physical activity on diabetic neuropathy and neurogenesis. There is no study on the impact of physical activity to manage early symptoms of peripheral diabetic neuropathy in patients with type-II diabetes in humans. This study finds the impact of moderate physical activity to manage early symptoms of peripheral diabetic neuropathy in patients with type-II diabetes in humans.
- Conditions
- Peripheral Diabetic Neuropathy
- Being tested
- Moderate Physical Activity for Peripheral Diabetic Neuropathy
- Keywords
- Type 2 diabetes mellitus, moderate physical activity, HbA1c, diabetic neuropathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Physical Activity for Peripheral Diabetic NeuropathyOther
Moderate physical activity can increase movement and heart rate are particularly important for people suffering with peripheral neuropathy. Physical activity can improve blood circulation, which strengthens nerve tissues by increasing the flow of oxygen.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Physical Activity Group | Experimental | The Experimental Group gets moderate physical activity. Elliptical will be performed at least 5 days/per week. Moderate intensity, corresponding approximately to 40-60% of Vo2max (maximal aerobic capacity) 150 min/week of exercise undertaken at moderate intensity or greater. Warm-up and Dynamic stretching is given before and static stretching is given after moderate physical activity. Receives: Other: Moderate Physical Activity for Peripheral Diabetic Neuropathy |
| Non Specific Physical Activity Group | No intervention | The Control group continues their regular medication for diabetic neuropathy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes
Research Hypothesis
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Oct 2021
- Primary completion30 Nov 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waqar Ahmed Awan, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491850
- Sponsor's protocol ID
- RIPHAH/FR&AHS/Letter-0985
- Status last verified
- Aug 2022
- First submitted
- 31 Jul 2022
- Last updated
- 8 Aug 2022
- 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 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moderate Physical Activity on Early Symptoms of Peripheral Diabetic Neuropathy in Type-II Diabetes: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05491850
- Acronym / sponsor ID
- RIPHAH/FR&AHS/Letter-0985
- Conditions
- Peripheral Diabetic Neuropathy
- Keywords
- Type 2 diabetes mellitus, moderate physical activity, HbA1c, diabetic neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 8 Aug 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.
This study determines the effects of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes. Most of the literature shows the impact of physical activity to manage/controlling diabetes. Some studies were conducted on animals to study the impact of physical activity on diabetic neuropathy and neurogenesis. There is no study on the impact of physical activity to manage early symptoms of peripheral diabetic neuropathy in patients with type-II diabetes in humans. This study finds the impact of moderate physical activity to manage early symptoms of peripheral diabetic neuropathy in patients with type-II diabetes in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Physical Activity Group | Experimental | Other: Moderate Physical Activity for Peripheral Diabetic NeuropathyThe Experimental Group gets moderate physical activity. Elliptical will be performed at least 5 days/per week. Moderate intensity, corresponding approximately to 40-60% of Vo2max (maximal aerobic capacity) 150 min/week of exercise undertaken at moderate intensity or greater. Warm-up and Dynamic stretching is given before and static stretching is given after moderate physical activity. |
| Non Specific Physical Activity Group | No intervention | –The Control group continues their regular medication for diabetic neuropathy. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with Type-II Diabetes
- Diagnosed cases of Peripheral Diabetic Neuropathy
- Peripheral Diabetic Neuropathy Stage 1 \& 2
- Numbness or reduced ability to feel pain or temperature changes.
- Tingling or burning sensation.
Key exclusion criteria (7 listed)
- Cardiac Issues
- Any neurological issue
- Lower limb deformity
- Acute injury
- Hip and Knee OA
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 |
|---|---|---|
| Moderate Physical Activity for Peripheral Diabetic NeuropathyModerate physical activity can increase movement and heart rate are particularly important for people suffering with peripheral neuropathy. Physical activity can improve blood circulation, which strengthens nerve tissues by increasing the flow of oxygen. | Other | Moderate Physical Activity Group |
Primary outcome
Effect of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes
Time frame: 2 Months
Research Hypothesis
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 8 Aug 2022.
- 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.
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 Moderate Physical Activity for Peripheral Diabetic Neuropathy in people with Peripheral Diabetic Neuropathy, run by Riphah International University 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 12 inclusion and 7 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 8 Aug 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 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?
Effect of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes (time frame: 2 Months). 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 8 Aug 2022.