NCT03203278

Brief Summary

This randomised controlled trial aims to investigate the effect of a 12 week personalised exercise programme delivered using a web-based platform, compared to usual care, on glycaemic control, muscle strength, functional ability, blood lipid profile, blood pressure and quality of life in adult South Asians with Type 2 Diabetes Mellitus

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 27, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

10 months

First QC Date

June 27, 2017

Last Update Submit

November 20, 2018

Conditions

Diabetes Mellitus, Type 2

Keywords

South Asian

Outcome Measures

Primary Outcomes (1)

  • Glycaemic control

    Change in HbA1c

    Baseline to 12 weeks

Secondary Outcomes (28)

  • Blood lipid profile (cholesterol)

    Baseline to 12 weeks

  • Blood lipid profile (cholesterol)

    12 weeks to 20 weeks

  • Blood lipid profile (high density lipoproteins)

    Baseline to 12 weeks

  • Blood lipid profile (high density lipoproteins)

    12 weeks to 20 weeks

  • Blood lipid profile (low-density lipoproteins)

    Baseline to 12 weeks

  • +23 more secondary outcomes

Study Arms (2)

Web-based exercise programme

EXPERIMENTAL

Personalised exercise programme, undertaken three times a week (with no more than two rest days between sessions) for 12 weeks

Behavioral: Web-based exercise programme

Control group

NO INTERVENTION

Usual care

Interventions

Web-based exercise programmeBEHAVIORAL

Aerobic, resistance and balance exercises

Web-based exercise programme

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • define themselves as South Asians
  • BMI 21 - 29.9 kg/m2
  • diagnosed with Type 2 Diabetes Mellitus (T2DM) by a physician more than 6 months previously
  • access to a personal computer/tablet, smart phone or smart television with an email address and Internet connection
  • able to understand English or Urdu

You may not qualify if:

  • type 1 diabetes
  • any medical conditions that would affect adherence or contraindicate exercise including severe peripheral neuropathy, severe autonomic neuropathy, severe physical limitations, heart disease, pre-proliferative or proliferative retinopathy, uncontrolled hypertension (\>180/ 100mmHg), or coronary artery disease.
  • people using insulin if they do not have a self-monitoring glucose device or are unable to use such devices.
  • engaging in exercise training of 150 minutes a week or more
  • participating in other interventional studies aiming to improve glycaemic control
  • unwilling to be randomised

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lorna Paul, PhD

    Glasgow Caledonian University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2017

First Posted

June 29, 2017

Study Start

November 6, 2017

Primary Completion

August 22, 2018

Study Completion

August 22, 2018

Last Updated

November 23, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)