NCT06387550

Brief Summary

Diabetes is defined by the level of hyperglycemia its a metabolic chronic disorder that furthur lead to life threatning medical conditions however, the prevalence of diabetes is rapidly increasing day by day in both developed and developing countries making it global pandemic and type II is more prevalent. Life dependency is increased due to long term effects of diabetes in specifically older individuals. Physical activity and exercise improves glucose tolerance and also reduces other life threatening diabetic complications, improving the quality of life in diabetic population.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 23, 2024

Last Update Submit

April 23, 2024

Conditions

Keywords

Eccentric training, Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Glycemic control

    Lab investigation of glycemic control will be through HBA1C test.

    8 weeks

  • Patient's quality of life

    Quality of life will be assessed using EQ5DL Questionnaire.

    8 weeks

Study Arms (1)

Eccentric Training Group

EXPERIMENTAL

Patients in this group firstly passing through warm up phase that include hip circles and shoulder rolls(1 sets of 5 reps), participants are trained on bicycle ergometer for 15 minutes on 2-3 times a week and its duration is increased according to patient tolerance, after that they will be pass through exercise phase that include squating, lunges and leg press (8-10 reps of 3 sets) after that cool down phase begin that include cat cow stretch and oblique stretch (5 reps of 1 set)

Procedure: Eccentric Training

Interventions

Warm up phase that include hip circles and shoulder rolls(1 sets of 5 reps), participants are trained on bicycle ergometer for 15 minutes on 2-3 times a week and its duration is increased according to patient tolerance, after that they will be pass through exercise phase that include squating, lunges and leg press (8-10 reps of 3 sets) after that cool down phase begin that include cat cow stretch and oblique stretch (5 reps of 1 set)

Eccentric Training Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both gender
  • Blood pressure should be \<140/90mm of Hg
  • Diagnosed Diabetic patient (HBA1C\>6.4%)
  • Adults (Age 40 +) from Rawalpindi and Islamabad

You may not qualify if:

  • Acute infection
  • History of recent trauma
  • Acute coronary syndrome
  • Peripheral vascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Hajab Zehra, MS-MSKPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a pre-post quasi experimental study having one group analysis.Participants will be selected through inclusion and exclusion criteria then pre assessment would be done that include HBA1C and EQ5DL QOL tool, followed by intervention and post assessment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 29, 2024

Study Start

March 20, 2024

Primary Completion

July 1, 2024

Study Completion

July 15, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04

Locations