NCT03103126

Brief Summary

The study aims to investigate whether 12 weeks of structured aerobic and resistance exercises completed at home can have a beneficial effect on the health of patients with type 2 diabetes compared to standard physical activity advice. The study will investigate whether the exercises can reduce factors such as patient's BMI, blood pressure and waist circumference, as well as blood glucose and insulin sensitivity. Participants will use pedometers and Therabands to carry out their exercises. This will be compared to giving participants a physical activity advice sheet and no structured exercise examples.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2019

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 20, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
2.1 years until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

March 20, 2017

Last Update Submit

March 24, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

pedometer-determined walkingresistance exercise

Outcome Measures

Primary Outcomes (1)

  • The effects of home-based combined exercise on insulin sensitivity compared to physical activity advice during the 6 week study period

    Insulin sensitivity will be calculated from plasma glucose and serum insulin measures

    6 weeks

Secondary Outcomes (9)

  • The effects of HBCE on body mass index (BMI) compared to physical activity advice during the 6 week study period

    6 weeks

  • The effects of HBCE on waist circumference compared to physical activity advice during the 6 week study period

    6 weeks

  • The effects of HBCE on body fat percentage compared to physical activity advice during the 6 week study period

    6 weeks

  • The effect of HBCE on physical activity levels compared to physical activity advice during the 6 week study period

    6 weeks

  • The effect of HBCE on fitness compared to physical activity advice during the 6 week study period

    6 weeks

  • +4 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Standard care.

Combined resistance exercise and walking

EXPERIMENTAL

Combined resistance exercise and walking.

Behavioral: Combined resistance exercise and walking

Interventions

Combined resistance exercise and walkingBEHAVIORAL

Combined resistance exercise and walking

Combined resistance exercise and walking

Eligibility Criteria

Age18 Years - 90 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGender is not an eligibility or outcome measure so self-representation will suffice as an indicator
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must not be meeting the government's recommended physical activity guideline (150 min moderate intensity exercise per week)
  • Must be 18 years of age or over
  • Diagnosed with Type 2 Diabetes and have been referred to DESMOND, as this is where they will be recruited from.

You may not qualify if:

  • ● Co-morbidity that prevents them undertaking physical activity safely, such as cardiac disease or pulmonary disease or significant musculoskeletal limitations. This will be determined from the Exercise and Health History Questionnaire. If their diabetes is severe and they have peripheral neuropathy or any associated systemic, cardiovascular, metabolic or musculoskeletal problems which will inhibit their ability to perform exercise safely.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrew Scott

Portsmouth, Hampshire, PO1 2ER, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Walking

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Andrew T Scott, PhD

    University of Portsmouth

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The conditions/treatments cannot be masked but the outcome assessors will be masked as to the arm that the participants are allocated to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial: control group vs. one intervention arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Lecturer

Study Record Dates

First Submitted

March 20, 2017

First Posted

April 6, 2017

Study Start

May 1, 2019

Primary Completion

July 1, 2019

Study Completion

September 1, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

The data will be stored in link-anonymised form and will not be made available outside of the research team.

Locations

GB(1)