Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
08/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew C Hutchesson

ORCID ID

Contact details

Consultant in Clinical Chemistry
Royal Bolton Hospital
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
+44 (0)1204 390 422
Andrew.Hutchesson@boltonh-tr.nwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

M0010111344

Study information

Scientific title

The effects of a 12-week exercise intervention on respiratory exchange ratio, body composition, thyroid function and lipid metabolism in hypothyroid, obese women

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nutritional, Metabolic, Endocrine: Obesity

Intervention

Patients who appear eligible to the inclusion criteria will be selected from among those having their thyroid function checked, and will be sent a letter via their GP. This letter invites the patient to give consent for the investigator to gain access to her address. If consent is given, the investigator will contact the patient by letter, inviting her to a meeting to discuss the study. Enclosed with this letter will be a patient information sheet and an informed consent form, which the patient will be invited to complete at or within 24 h after the end of the meeting. After recruitment patients randomised to the intervention group will receive a 12-week structured exercise program, supervised by the investigator. Patients in the control group will receive information on 'underactive thyroid' and will have their opportunity to participate in exercise delayed for 12 weeks. Before and after this period, all subjects will undergo: echocardiography and near infra-red spectrometry, respiratory exchange ratio (RER) rest and exercise, body composition analysis and serum lipid profile and thyroid function measurement. After the second (post-intervention) measurements, all subjects will receive a 3-month membership to the Bolton Excel Cardiogym, where they will have the opportunity to complete an exercise program under qualified gym supervision.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Percentage reduction in body fat.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

11/03/2002

Overall trial end date

01/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Obese (Body Mass Index [BMI] =30.1-40, American College of Sports Medicine [ACSM])
2. Female
3. Sedentary (>90min of moderate physical activity per week)
4. Age 40-50
5. Subclinical hypothyroidism ('mild hypothyroidism'): elevated thyroid stimulating hormone (TSH) 4-10 mU/l but within-normal-range serum and T4 levels (>8 pmol/l)
6. Able to attend exercise sessions

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

11/03/2002

Recruitment end date

01/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant in Clinical Chemistry
Bolton
BL4 0JR
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Bolton Hospitals NHS Trust (UK)

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

08/08/21016: No publications found in PubMed, verifying study status with principal investigator.