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Clinical Trials/CTRI/2024/05/066755
CTRI/2024/05/066755CompletedPhase 3

Effect of blood flow restriction training on foot pain, disability and functional activities of daily living among diabetic adult population- A randomized controlled trial

Galgotias University1 site in 1 country50 target enrollmentStarted: May 15, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Foot function Index will be used to assess foot-related pain, disability, and activity limitations

Study Overview

Brief Summary

This randomized controlled trial investigates the impact of blood flow restriction training on foot pain, disability, and functional activities of daily living in diabetic adults. Participants will be randomized into intervention and control groups, with the intervention group undergoing blood flow restriction training while the control group receives standard care. Outcome measures include foot pain intensity, disability using the Foot Function Index, and functional activities of daily living using the SF-36 Health Survey. The study aims to provide insights into the efficacy of blood flow restriction training in improving the quality of life and functional outcomes in diabetic individuals with foot complications.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Diabetic adults (Type 1 or Type 2).
  • Presence of foot pain, disability, or limitations in daily activities.
  • Stable medical condition without contraindications for exercise.

Exclusion Criteria

  • Severe peripheral vascular disease.
  • Recent foot ulcerations or infections.
  • Inability to participate in exercise programs due to other medical conditions.

Outcomes

Primary Outcomes

Foot function Index will be used to assess foot-related pain, disability, and activity limitations

Time Frame: Baseline, 4 weeks and after 6 weeks.

The Barthel Index Wwill be used for assessing activities of daily living (ADL)

Time Frame: Baseline, 4 weeks and after 6 weeks.

Secondary Outcomes

  • SF36 The SF-36 will be used to assess health-related quality of life(Baseline, 4 weeks and 6 weeks)

Investigators

Sponsor
Galgotias University
Sponsor Class
Research institution
Responsible Party
Principal Investigator
Principal Investigator

Dr Adarsh Kumar Singh

Galgotias University

Study Sites (1)

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