Effect of a 12 week supervised exercise programme 12–24 months after weight-loss surgery on physical function and physical activity maintenance: the Motion Study

• Register: ISRCTN
• Last refreshed on: 4 September 2017
• Main ID: ISRCTN17240262
• Date of registration: 06/02/2015
• Prospective Registration: No
• Primary sponsor: University of Leicester
• Public title: Effect of a 12 week supervised exercise programme 12–24 months after weight-loss surgery on physical function and physical activity maintenance: the Motion Study
• Scientific title: Effect of a 12 week supervised exercise programme 12–24 months after bariatric surgery for obesity on physical function and physical activity maintenance: a randomised controlled trial
• Date of first enrolment: 26/02/2014
• Target sample size: 52
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN17240262
• Study type: Interventional
• Study design: Interventional single-centre study (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Louisa Herring

Key inclusion & exclusion criteria

Inclusion criteria: 1. Age 18–60 years old
2. Had bariatric surgery in past 12–24 months
3. Body-mass index (BMI) of at least 30 kg/m2 (=28 kg/m2 for South Asian people)
4. Completion of a stress test and approval from an in-house clinician in accordance with our standard operating procedure and document
Exclusion criteria: 1. Highly active individuals or individuals meeting current physical activity guidelines (self-report of =2·5 hours per week)
2. Unstable diabetes
3. Orthopaedic limitations
4. Motor neurone disease
5. Stage II hypertension (systolic blood pressure >60 mmHg and/or diastolic blood pressure >100 mmHg)
6. Cardiovascular disease: coronary artery disease, cardiomyopathy, heart failure, cor pulmonale, cardiac dysrhythmias, endocarditis, myocarditis, valvular heart disease, cerebrovascular disease, peripheral arterial disease, congenital heart disease and rheumatic heart disease
7. Pulmonary disease: inflammatory lung disease, obstructive lung disease, chronic obstructive pulmonary disease, emphysema, cystic fibrosis, respiratory tract infections, pleural cavity disease and pulmonary vascular disease
8. Renal disease
9. Chair bound
10. Weight limit of 200 kg or greater


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Obesity
Digestive System
Obesity

Intervention(s)

Patients will be randomly assigned to one of two groups:
1. Exercise group: moderate intensity exercise combining aerobic and resistance exercise
1.1 Pre-intervention (baseline) assessment
1.2. 12 week hospital-based moderate intensity exercise intervention (3 x 60 minute sessions per week)
1.3. Ongoing behavioural counselling incorporated into sessions (through ongoing client–trainer interaction)
1.4. Post-intervention assessment (at about 12 weeks)
1.5. Patient-specific advice session (30–60 minutes) to discuss relevant topics (e.g., physical activity maintenance, overcoming barriers and goal setting); patients will be offered an optional exercise programme of their choice (e.g., home based, walking outside, gym or swimming); and they will be given a diet information sheet
1.6. 6 month follow-up assessment
2. Control group
2.1. Pre-intervention (baseline) assessment
2.2. 12 weeks of no structured exercise
2.3. Post-intervention assessment (at about 12 weeks)
2.4. Patient-specific advice session (60 minutes) to discuss relevant topics (e.g., physical activity maintenance, overcoming barriers and goal setting); patients will be offered an exercise programme of their choice (e.g., home based, gym or swimming); and they will be given a diet information sheet
2.5. 6 month follow-up assessment

Primary Outcome(s)

Incremental shuttle walk test (metres): will be measured at baseline, 3 months and 6 months

Secondary Outcome(s)

1. Grip strength (kg), measured with a analogue hand grip dynamometer
2. Seat to stand test (seconds), using a 5 x seat to stand protocol
3. Body composition: measured using Tanita bioelectrical impedance scales (BC-418-MA)
4. Height (cm), measured by a SECA stadiometer
5. Weight (kg), measured by Tanita bioelectrical impedance scales (BC-418-MA)
6. Waist and hip circumference (cm), measured with a SECA tape measure
7. Physical activity, measured by Actigraph GT3X+ accelerometer
8. Self-reported physical activity, measured with the Short form International Physical Activity Questionnaire (IPAQ)
9. Blood pressure (mmHg), measured with an automated Intelle sense blood pressure machine (arm cuff)
10. Resting heart rate (beats per minute), measured with a finger pulse oximeter
11. Oxygen saturation (%), measured with a finger pulse oximeter
12. Dietary intake, measured with a 24-hour food recall
13. Self-efficacy, measured using the self-efficacy to regulate physical activity (SERPA) questionnaire
14. Anxiety and depression measured with the Hospital Anxiety and Depression Scale (HADS)
15. Medications and doses: obtained from medical notes
18. Cholesterol, measured with venous blood specimens
19. High-density lipoprotein, measured with venous blood specimens
20. Low-density lipoprotein, measured with venous blood specimens
21. Triglycerides, measured with venous blood specimens
22. Non-fasting glycated haemoglobin, measured with venous blood specimens
All these outcomes will be measured at baseline, 3 months and 6 months.

Secondary ID(s)

120659

Source(s) of Monetary Support

Leicester Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit (UK)