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Trial registered on ANZCTR


Registration number
ACTRN12616000991415
Ethics application status
Approved
Date submitted
23/07/2016
Date registered
27/07/2016
Date last updated
27/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of low and moderate intensity exercise on quality of life in overweight or obese men and women: A pilot study
Scientific title
Impact of low and moderate intensity exercise on quality of life in overweight or obese men and women: A pilot study
Secondary ID [1] 289374 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 299009 0
Condition category
Condition code
Diet and Nutrition 299067 299067 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exercise program consisted of twice weekly, one hour small group classes involving a combination of aerobic and resistance training in a supervised environment. Time restraints and availability of the gym facilities prevented additional classes from being provided and longer class durations.

Aerobic and resistance training exercise was performed to coincide with current exercise guidelines. The aerobic component involved 15 minutes of treadmill walking or jogging and 15 minutes on an exercise bike. Resistance exercise included calf raises, lunges, squats and shoulder press. Resistance exercises were chosen to target the major muscle groups of the upper and lower limbs whilst remaining within the time restrictions. Participants performed three sets of 10 repetition of each of these resistance exercises and used a variety of free weights depending on their level of fitness and corresponding heart rate. Participants were encouraged to perform a five minute warm up on one of the exercise machines before each class and time was allocated for stretching at the completion of each session. Stretches performed post exercise were up to the individual, with no strict structure for 30 second holds for each muscle group stretched.

The exercise program for both groups was identical in terms of volume and type with the only difference being exercise intensity. The intensity of the exercise was established by using percentage of maximal heart rate (MHR) with low intensity exercise being defined as 40-55% MHR and moderate intensity as 55-70% MHR. Each participants MHR was estimated by subtracting their age in years away from 220. Individual MHR were used to calculate their target heart rate zone in correlation with their allocated exercise group. Each participant was required to wear a heart rate chest strap and watch which allowed them to constantly monitor their heart rate. Participants were informed of their target heart rate zone and were instructed to stay between these values whilst exercising. The personal trainer would regularly monitor participant’s heart rates to ensure they were remaining within their target heart rate zone.

The exercise classes consisted of small groups (5-7 people) and ran for 5 weeks with twice weekly, one hour long classes. Attendance was monitored and recorded and only participants who achieved an attendance rate of 70% or greater had their data utilized.

Current Australian physical activity guidelines for overweight or obese individuals recommend approximately 300 minutes of moderate intensity activity, or 150 minutes of vigorous activity per week to achieve weight loss (National Health and Medical Research Council (2013) Clinical practice guidelines for the management of overweight and obesity in adults, adolescents and children in Australia. Retrieved from National Health and Medical Research Council website: https://www.nhmrc.gov.au/guidelines-publications/n57)
Intervention code [1] 294962 0
Treatment: Other
Comparator / control treatment
Participants randomly allocated into group A or group B
Group A: Low intensity exercise
Group B: Moderate intensity exercise
Control group
Active

Outcomes
Primary outcome [1] 298544 0
Change in QOL following exercise intervention in overweight or obese individuals using SF-36 V1 Quality of Life questionnaire
Timepoint [1] 298544 0
Baseline and at the end of the 5 week intervention
Secondary outcome [1] 324525 0
Body weight. using digital scales
Timepoint [1] 324525 0
Baseline and at the end of the 5 week intervention
Secondary outcome [2] 326010 0
Waist Circumference. Assessed by physiotherapist using tape measure
Timepoint [2] 326010 0
Baseline and at the end of the 5 week intervention
Secondary outcome [3] 326011 0
Body Mass Index. Using digital scales and a stadiometer
Timepoint [3] 326011 0
Baseline and at the end of the 5 week intervention
Secondary outcome [4] 326012 0
Systolic blood pressure by sphygmomanometry
Timepoint [4] 326012 0
Baseline and at the end of the 5 week intervention
Secondary outcome [5] 326013 0
Diastolic Blood Pressure by sphygmomanometry
Timepoint [5] 326013 0
Baseline and at the end of the 5 week intervention

Eligibility
Key inclusion criteria
Overweight or obese (Overweight/Pre obese = Body Mass Index of 25-29.99, Obese (Class 1 & 2) = Body Mass Index of 30-39.99). Data regarding definition of overweight/obese retrieved from http://www.measureup.gov.au/internet/abhi/publishing.nsf/Content/Weight,+waist+circumference+and+BMI-lp

Able to attend twice weekly exercise class at the Charles Sturt University Physiotherapy/Podiatry clinic, Thurgoona.

Understand and accept that they may perform low or moderate intensity exercise depending on their random group allocation

Completed health screening by allied health professional
Minimum age
20 Years
Maximum age
54 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability or refusal to provide informed consent or complete pre-exercise screening

Any contraindication to exercise requirements such as recent heart disease or myocardial infarction, peripheral vascular disease, severe illness or infection and any medications that interfere with or alter heart rhythm (Information obtained from medical history questionnaire and pre exercise subjective and objective assessment).

Any chronic disease such as diabetes and metabolic syndrome or health conditions such as previous stroke or heart attack (Information obtained from medical questionnaire and pre exercise subjective and objective assessment)

Blood glucose measure using glucometer that does not lie between 70-125 mg/dL (not fasting) (National Institutes of Health. (2014). Glucose test – blood. Retrieved from
http://www.nlm.nih.gov/medlineplus/ency/article/003482.htm) (Standards of medical care in diabetes--2012.(POSITION STATEMENT). (2012). Diabetes Care, 35(1), S11.).

Systolic blood pressure above 139 or below 90 (mmHg) and diastolic blood pressure above 89 or below 60 at rest. (American Heart Association. (2011). Understanding blood pressure readings. Retrieved from
(http://www.heart.org/HEARTORG/Conditions/HighBloodPressure/AboutHighBloodPressure/Understanding-Blood-Pressure-Body mass index of lower than 25 or greater than or equal to 40 to exclude morbid obesity and persons of normal to low body weight
(http://www.measureup.gov.au/internet/abhi/publishing.nsf/Content/Weight,+waist+circumference+and+BMI-lp).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Flip of coin for group allocation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All data was analysed using IBM SPSS V20. Only participants who achieved an attendance rate of greater than 80% and who completed a pre and post exercise assessment of outcome measures were included in the data analysis. An 80% attendance rate was decided on to ensure the reliability of results. Lower participation rates may have provided inaccurate results and falsely skewed data.

A Mixed-Design (Split-Plot) ANOVA for repeated measures over time was used to compare the effects of the interventions on QOL and secondary outcome measures. Independent samples t-tests were performed to examine differences between exercise groups. Statistical significance was set at p < 0.05 throughout the analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 13440 0
2640 - Thurgoona

Funding & Sponsors
Funding source category [1] 293902 0
University
Name [1] 293902 0
Charles Sturt University
Address [1] 293902 0
Elizabeth Mitchell Dr, Albury NSW, 2640
Country [1] 293902 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
Elizabeth Mitchell Dr, Albury NSW, 2640
Country
Australia
Secondary sponsor category [1] 292727 0
Individual
Name [1] 292727 0
Wade McGrath
Address [1] 292727 0
Elizabeth Mitchell Dr, Albury NSW, 2640
Charles Sturt University
Country [1] 292727 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295317 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [1] 295317 0
Elizabeth Mitchell Dr, Albury NSW 2640
Ethics committee country [1] 295317 0
Australia
Date submitted for ethics approval [1] 295317 0
28/10/2014
Approval date [1] 295317 0
03/12/2014
Ethics approval number [1] 295317 0
2014/200

Summary
Brief summary
The purpose of the study is to address the gap in literature regarding the use of exercise as an intervention to improve quality of life in overweight or obese individuals.

The rates of obesity and overweight are increasing rapidly in Australia and worldwide. Overweight and obesity increase the risk of developing chronic diseases like type 2 diabetes, cardiovascular disease, hypertension, stroke and other health conditions. In addition to these risks, increased weight is linked to lower health related quality of life (QOL) scores when compared to healthy weight individuals.

The effects of exercise for improving body weight have been well established from previous studies. Physical activity has also been found to improve cardiovascular disease risk factors, with or without weight loss.

An increasing number of studies involving overweight or obese participants are utilising QOL as an outcome measure as it is now considered a vital part of an individual’s health status. Exercise and lifestyle change studies have found improvements in QOL scores in these individuals. Exercise programs that achieve weight loss have also been found to improve QOL scores, with and without the inclusion of dietary change. Despite these findings there have been no studies to date which have investigated the optimal exercise intensity to maximise improvements in QOL in overweight or obese individuals.

Current Australian physical activity guidelines for overweight or obese individuals recommend approximately 300 minutes of moderate intensity activity, or 150 minutes of vigorous activity per week to achieve weight loss. In contrast to these clear recommendations there exist no clinical guidelines regarding exercise prescription for maximising improvements in QOL in these individuals. Most previous trials targeting QOL in overweight or obese peoples or in the general population follow the physical activity guidelines for achieving weight loss and have not attempted to compare the effect of differing exercise intensities on QOL improvements.

This research study aimed to show the impact of regular physical activity as a method of improving QOL in overweight or obese persons. It also aimed to establish whether low or moderate intensity exercise was superior for maximising improvements in QOL in these individuals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66458 0
Mr Wade McGrath
Address 66458 0
Elizabeth Mitchell Dr, Albury NSW, 2640
Charles Sturt University
Country 66458 0
Australia
Phone 66458 0
+61438639393
Fax 66458 0
Email 66458 0
wademcgrath7@hotmail.com
Contact person for public queries
Name 66459 0
Mr Wade McGrath
Address 66459 0
Elizabeth Mitchell Dr, Albury NSW, 2640
Charles Sturt University
Country 66459 0
Australia
Phone 66459 0
+61438639393
Fax 66459 0
Email 66459 0
wademcgrath7@hotmail.com
Contact person for scientific queries
Name 66460 0
Mr Wade McGrath
Address 66460 0
Elizabeth Mitchell Dr, Albury NSW, 2640
Charles Sturt University
Country 66460 0
Australia
Phone 66460 0
+61438639393
Fax 66460 0
Email 66460 0
wademcgrath7@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary