Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/05/2006
Date assigned
16/10/2006
Last edited
13/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Raj Padwal

ORCID ID

Contact details

Clinical Pharmacology and Internal Medicine
University of Alberta
2E3.22 Walter C. Mackenzie Health Sciences Center
8440 - 112 Street
Edmonton
Alberta
T6G 2B7
Canada
+1 780 407 8153
rpadwal@ualberta.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RF-06-0419

Study information

Scientific title

Acronym

CT, ORH & BP

Study hypothesis

In comparison with the Usual Care group (UC), obese hypertensive individuals undergoing 12 weeks of Circuit Weight Training (CWT), will exhibit greater reductions in blood pressure.

Ethics approval

University of Alberta Health Research Ethics Board (HREB) (ref no: 6276).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Obesity and /or resistant hypertension

Intervention

Circuit Weight Training (CWT) group: Individuals will be prescribed an exercise regimen based on baseline fitness and strength assessments and their exercise blood pressure response. Loads prescribed will be low resistance but high volume (two to three sets of 15 repetitions). Subjects will be asked to train on at least three non-consecutive days of the week and given free membership to local health club facilities for the duration of the intervention (12 weeks). Adherence to CWT intervention will be monitored via electronic attendance records at the health club facilities

Usual Care (UC) Group: Individuals randomly assigned to the usual care group will be asked to continue their current level of activity for the duration of the intervention (12 weeks).

Both groups will recieve the same nutritional counselling at the start of the intervention.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Efficacy of prescribing circuit weight training in reducing blood pressure of obese resistant hypertensives

Secondary outcome measures

1. Effiacy of circuit weight training in reducing weight
2. Increasing cardio-respiratory endurance
3. Improving glycemic control and lipid profiles
4. Enhancing Health Related Quality of Life (HRQL)

Overall trial start date

01/06/2006

Overall trial end date

01/02/2007

Reason abandoned

This study has been cancelled due to the private fitness centre pulling out of the trial.

Eligibility

Participant inclusion criteria

1. Aged 25 to 70 years
2. Obese (Body Mass Index [BMI] more than 30 kg/m^2)
3. Mean 24 hour ambulatory blood pressure of 150/99 mmHg or less (on drug therapy)

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

40 (20 randomised into either group)

Participant exclusion criteria

1. White-coat hypertension
2. Secondary hypertension
3. Unstable cardiovascular disease
4. Not residing in Edmonton or the surrounding area

Recruitment start date

01/06/2006

Recruitment end date

01/02/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Clinical Pharmacology and Internal Medicine
Alberta
T6G 2B7
Canada

Sponsor information

Organisation

University of Alberta (Canada)

Sponsor details

114 St - 89 Avenue
Edmonton
Alberta
T6G 2E1
Canada

Sponsor type

University/education

Website

http://www.ualberta.ca

Funders

Funder type

Hospital/treatment centre

Funder name

University of Alberta Hospital Foundation (Canada) (ref: RF-06-0419)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes