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

ISRCTN	ISRCTN52563354
DOI	https://doi.org/10.1186/ISRCTN52563354
Secondary identifying numbers	M0010111344

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 08/08/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrew C Hutchesson
Scientific

Consultant in Clinical Chemistry
Royal Bolton Hospital
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom

Phone	+44 (0)1204 390 422
Email	Andrew.Hutchesson@boltonh-tr.nwest.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Percentage reduction in body fat.
Secondary outcome measures	Not provided at time of registration
Overall study start date	11/03/2002
Completion date	01/09/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	11/03/2002
Date of final enrolment	01/09/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Consultant in Clinical Chemistry

Bolton
BL4 0JR
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

Bolton Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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