Peripheral Diabetic NeuropathyNCT06964542
Effect of Supervised in Comparison to Non-supervised Multicomponent Exercise Training on Balance and Quality of Life in Peripheral Diabetic Neuropathy
A study testing Multicomponent exercise intervention and Non Supervised in people with Peripheral Diabetic Neuropathy, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
THIS STUDY IS A RANDOMIZED CONTROL TRIAL AND THE PURPOSE OF THIS STUDY IS TO DETERMINE THE effect of supervised in comparison to non-supervised multicomponent exercise training on balance and quality of life in peripheral diabetic neuropathy Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Peripheral Diabetic Neuropathy
- What is being tested?
- Multicomponent exercise intervention and Non Supervised
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2024to 30 May 2025
- 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55-70 years (both male and female)
- Diagnosed patients of diabetes type 2, 10 years after disease
- Completely assessed with Michigan Neuropathy Screening Instrument (MNSI) score scale and patients fulfilling this criterion will be included in this study
- Patients who are fulfilling PARQ will be included in study
Who cannot join
- Hypoglycemia
- Patient having ischemic heart diseases will not be included
- unable to walk independent
- major orthopedic problems (e.g. lower limb fractures)
- Diagnosed neurological and psychological patients
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Thrapy
Islamabad, 44000
About this study
THIS STUDY IS A RANDOMIZED CONTROL TRIAL AND THE PURPOSE OF THIS STUDY IS TO DETERMINE THE effect of supervised in comparison to non-supervised multicomponent exercise training on balance and quality of life in peripheral diabetic neuropathy
Read the detailed description
Effect of exercises to assess the benefits on strength endurance, balance and mobility.
Peripheral Neuropathy aged 55-70 will be recruited in the study. The participants would be assessed through WHOQOL BREF, BERG BALANCE SCALE, TIME UP AND GO TEST .
Informed Consent will Be taken after which the participants will be recruited into the two groups, where one group will receive supervised exercise intervention while other group will receive non supervised exercise intervention
- Conditions
- Peripheral Diabetic Neuropathy
- Being tested
- Multicomponent exercise intervention, Non Supervised
- Keywords
- Endurance, Multicomponent exercise training, Diabetes Mellitus, Peripheral Diabetic Neuropathy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exercise interventionProcedure or surgery
Patient will be under the complete supervision of physical therapist in a clinical setup.A total of 18 sessions of supervised multicomponent exercise training, thrice a week on alternate days for 6 consecutive weeks, session will be of 45 mins. Multicomponent exercise training including strength and progressive resistance training exercises, actvities will inc. Seated Marching,heel raises,toe raises, sit - to-stand. And balance training activities will involve tandem stands,single leg stance,weight shifting and resistance activities including weight lifting according to feasibility.
Non SupervisedProcedure or surgery
In non supervised group , patient will receive all the intervention with the help of exercise diary and guidance provided by the physical therapist. Patient will perform 18 sessions, thrice a week on alternative days, for 6 consecutive days for 45 mins. In diary patient is provided the tick mark table in which patient will mark the attendance on days ptn will perform the exercise. Diary is a complete guidance for home based exercise program which include QR based videos of performance of all exercises and complete guidelines are provided in urdu for the better understanding along with pictorial information. In this program activities that patient will perform includes; stairs climbing, sit to stand, leg raises, side stepping, leg raises with weight on ankles starting from 1kg to 3kg. Walk starting from 20 minutes to 40 minutes till 6 weeks. Resistance and other activities will be included.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Group | Experimental | In supervised exercise intervention a multicomponent exercise training will be applied to group 1 patients for improveent of symptoms caused from diabetic peripheral neuropathy such as balance, endurance, strength and quality of life. Strength and resistive training along with aerobic and balance training will be applied to patients under the supervision of physical therapist in a clinical setup. Receives: Procedure: Multicomponent exercise intervention |
| NON SUPERVISED | Experimental | In non-supervised exercise training, patients will receive multicomponent exercise intervention without the supervision of physical therapist but still under the supervision of caregiver at home. Patients will be provided with the complete guidance in the form of exercise diary. This diary included all the protocols for exercise at home , it also included QR code. Receives: Procedure: Non Supervised |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Berg balance scale. The score range is 0-56, with higher scores indicating better balance and functional mobility.
Measured: 4 weeks
Strength
The MMT scale refers to the Manual Muscle Testing scale, a standardized method used by physical therapists and healthcare providers to assess muscle strength. It has 6 grades.
Measured: 4 weeks
ENDURANCE
6-Minute Walk Test (6MWT) ) is a widely used and validated test to assess endurance.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start10 Sep 2024
- Primary completion15 May 2025
- Study completion30 May 2025
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.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964542
- Sponsor's protocol ID
- FUI/CTR/2024/63
- Status last verified
- Dec 2025
- First submitted
- 1 May 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supervised in Comparison to Non-supervised Multicomponent Exercise Training on Balance and Quality of Life in Peripheral Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT06964542
- Acronym / sponsor ID
- FUI/CTR/2024/63
- Conditions
- Peripheral Diabetic Neuropathy
- Keywords
- Endurance, Multicomponent exercise training, Diabetes Mellitus, Peripheral Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 9 May 2025 (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 IS A RANDOMIZED CONTROL TRIAL AND THE PURPOSE OF THIS STUDY IS TO DETERMINE THE effect of supervised in comparison to non-supervised multicomponent exercise training on balance and quality of life in peripheral diabetic neuropathy
Detailed description
Effect of exercises to assess the benefits on strength endurance, balance and mobility.
Peripheral Neuropathy aged 55-70 will be recruited in the study. The participants would be assessed through WHOQOL BREF, BERG BALANCE SCALE, TIME UP AND GO TEST .
Informed Consent will Be taken after which the participants will be recruited into the two groups, where one group will receive supervised exercise intervention while other group will receive non supervised exercise intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Group | Experimental | Procedure: Multicomponent exercise interventionIn supervised exercise intervention a multicomponent exercise training will be applied to group 1 patients for improveent of symptoms caused from diabetic peripheral neuropathy such as balance, endurance, strength and quality of life. Strength and resistive training along with aerobic and balance training will be applied to patients under the supervision of physical therapist in a clinical setup. |
| NON SUPERVISED | Experimental | Procedure: Non SupervisedIn non-supervised exercise training, patients will receive multicomponent exercise intervention without the supervision of physical therapist but still under the supervision of caregiver at home. Patients will be provided with the complete guidance in the form of exercise diary. This diary included all the protocols for exercise at home , it also included QR code. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 55-70 years (both male and female)
- Diagnosed patients of diabetes type 2, 10 years after disease
- Completely assessed with Michigan Neuropathy Screening Instrument (MNSI) score scale and patients fulfilling this criterion will be included in this study
- Patients who are fulfilling PARQ will be included in study
Key exclusion criteria (5 listed)
- Hypoglycemia
- Patient having ischemic heart diseases will not be included
- unable to walk independent
- major orthopedic problems (e.g. lower limb fractures)
- Diagnosed neurological and psychological patients
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 |
|---|---|---|
| Multicomponent exercise interventionPatient will be under the complete supervision of physical therapist in a clinical setup.A total of 18 sessions of supervised multicomponent exercise training, thrice a week on alternate days for 6 consecutive weeks, session will be of 45 mins. Multicomponent exercise training including strength and progressive resistance training exercises, actvities will inc. Seated Marching,heel raises,toe raises, sit - to-stand. And balance training activities will involve tandem stands,single leg stance,weight shifting and resistance activities including weight lifting according to feasibility. | Procedure or surgery | Supervised Group |
| Non SupervisedIn non supervised group , patient will receive all the intervention with the help of exercise diary and guidance provided by the physical therapist. Patient will perform 18 sessions, thrice a week on alternative days, for 6 consecutive days for 45 mins. In diary patient is provided the tick mark table in which patient will mark the attendance on days ptn will perform the exercise. Diary is a complete guidance for home based exercise program which include QR based videos of performance of all exercises and complete guidelines are provided in urdu for the better understanding along with pictorial information. In this program activities that patient will perform includes; stairs climbing, sit to stand, leg raises, side stepping, leg raises with weight on ankles starting from 1kg to 3kg. Walk starting from 20 minutes to 40 minutes till 6 weeks. Resistance and other activities will be included. | Procedure or surgery | NON SUPERVISED |
Primary outcome
Balance
Time frame: 4 weeks
Berg balance scale. The score range is 0-56, with higher scores indicating better balance and functional mobility.
Strength
Time frame: 4 weeks
The MMT scale refers to the Manual Muscle Testing scale, a standardized method used by physical therapists and healthcare providers to assess muscle strength. It has 6 grades.
ENDURANCE
Time frame: 4 weeks
6-Minute Walk Test (6MWT) ) is a widely used and validated test to assess endurance.
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 2025.
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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 Multicomponent exercise intervention and Non Supervised in people with Peripheral Diabetic Neuropathy, run by Foundation University Islamabad 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 4 inclusion and 5 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 2025. 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?
Balance (time frame: 4 weeks). 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 31 Dec 2025.