Plain English Summary
Background and aims
Knee osteoarthritis (OA) is a major public health problem worldwide, as well as the most common long-term illness among older adults. Knee OA may result in pain, discomfort and stiffness which may in turn restrict activities of daily living and have a negative effect on quality of life. This is more likely to happen in someone who is also overweight or obese. Current clinical guidelines and recommendations to help manage knee OA emphasise the importance of both diet and exercise on reducing weight and improving function. The effect of combined diet and exercise in overweight older adults with knee OA has been evaluated in the United States but no UK studies have been published to date. The main aim of this study is to evaluate the feasibility of a combined programmed of exercise and diet for older adults with obesity and knee OA.
Who can participate?
Obese patients aged 45-90 years, who have been referred to an outpatient clinic and physiotherapy department at the Royal Orthopaedic Hospital, Birmingham with knee OA
What does the study involve?
All participants receive an initial education session about knee OA, advice about physical activity, healthy diet and ideal weight. They then follow a diet alongside usual physiotherapy care for 4 months. They are asked to attend three assessment sessions to complete a questionnaire, undertake some physical tests and provide a small sample of blood. Also, they are asked to attend a group discussion at the end of the study to give their feedback and report their experience of participating in the study.
What are the possible benefits and risks of participating?
Regular exercise has many benefits. It is possible that the participation in this study may result in improved physical function as well as quality of life. This may be further helped by controlling diet. We cannot guarantee that participants will receive all of these benefits but we would be surprised if they didn’t receive any. However the main purpose of the study is to find out whether the delivery of a combined diet and exercise programme is acceptable to older adults with knee OA. So although this study may not benefit participants directly, the information we get from the study will help us design future studies to improve the management of knee OA. We have taken every step in the design of this study to minimise any possible disadvantages and risks. Safety considerations for exercise will be explained to participants during the educational session before starting the exercise classes. All the sessions will be carried under a supervision of trained physiotherapist and the diet plans will be designed by a member of the study team who is a clinical dietician.
When is the study starting and how long is it expected to run for?
December 2017 to November 2018
Who is funding the study?
University of Birmingham (UK)
Who is the main contact?
1. Ms Asma Alrushud (scientific)
2. Dr Carolyn Greig (public)
Trial website
Contact information
Type
Scientific
Primary contact
Ms Asma Alrushud
ORCID ID
http://orcid.org/0000-0002-5572-8897
Contact details
School of Sport
Exercise and Rehabilitation Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Type
Public
Additional contact
Dr Carolyn Greig
ORCID ID
Contact details
School of Sport
Exercise and Rehabilitation Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ERN_16-1432
Study information
Scientific title
The effect of a combined programme of dietary restriction and physical activity on the physical function and body composition of obese middle aged and older adults with knee OA (DRPA): Feasibility study
Acronym
DRPA
Study hypothesis
A combined intervention programme of dietary restriction plus usual care for older adults with knee OA is feasible, acceptable and effective. Also, it is hypothesized that all outcome measures including body weight, waist circumference, knee joint inflammation and pain will be reduced and physical function and quality of life will be improved.
Ethics approval
1. West Midlands - Solihull Research Ethics Committee, 12/05/2017, ref: 17/WM/0122
2. HRA approved protocol number ERN_16-1432; RG_17-024, Version 6.0 01/03/2018
Study design
Single-centre feasibility study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Knee osteoarthritis
Intervention
Current interventions as of 06/06/2018:
Participants will be recruited via the ROH outpatient clinic and physiotherapy department. Potential participants will be identified by a ROH clinician or senior physiotherapists according to the eligibility criteria. Eligible participants will be provided with a copy of the participant information sheet and a response slip, which will include a telephone number and email address to contact the study team directly and a stamped addressed envelope for those who prefer to respond by post.
After consenting to participate, participants will be invited to attend the Sport, Exercise and Rehabilitation School (SportExR), University of Birmingham where the study procedures will be explained in further detail, participants will be given the opportunity to ask questions, informed consent will be obtained and baseline data collected. Participants will be asked to complete a 3-day food diary (week day and week end) and to return it by post to a member of the study team (using the stamped addressed envelope provided to them), and a date will be scheduled to begin the exercise classes at ROH. The first class will be preceded by an educational session about knee OA, during which participants will be given the opportunity to ask any further questions. The study will be run in the physiotherapy gym under the supervision of a physiotherapist for one month.
Participants will receive a physiotherapy usual care programme for knee OA (stretching and strengthening exercise) for 60min/week. Participants will continue to exercise in their local gyms for 3 months. The study team will assist participants with application for a free (or discounted, funded by the study) gym pass via the Birmingham Be Active scheme. Participants will follow dietary restriction throughout the 4 months of the intervention and we aim for a decrease of 300-500 kcal.day-1 or 500-1000 kcal.day-1 as appropriate to initial BMI. The diet will be planned and modified (if needed) by a qualified clinical dietician. All outcome measures will be recorded 3 times except the biomarkers of joint remodelling and body composition only at baseline and 16 weeks. Finally, feasibility questionnaire and focus groups will be organised.
Participants focus group and feasibility questionnaire for ROH physio staff will be completed at the final assessment point (week 16).
Previous interventions:
Participants will be recruited via the ROH outpatient clinic after being identified by a ROH clinician according to the eligibility criteria. Eligible participants will be provided with a copy of the participant information sheet and a response slip, which will include a telephone number and email address to contact the study team directly and a stamped addressed envelope for those who prefer to respond by post.
After consenting to participate, participants will be invited to attend the Sport, Exercise and Rehabilitation School (SportExR), University of Birmingham where the study procedures will be explained in further detail, participants will be given the opportunity to ask questions, informed consent will be obtained and baseline data collected. Participants will be asked to complete a 3-day food diary (week day and week end) and to return it by post to a member of the study team (using the stamped addressed envelope provided to them), and a date will be scheduled to begin the exercise classes at ROH. The first class will be preceded by an educational session about knee OA, during which participants will be given the opportunity to ask any further questions. The study will be run in the physiotherapy gym under the supervision of a physiotherapist for one month.
Participants will receive a physiotherapy usual care programme for knee OA (stretching and strengthening exercise) for 60min/week. Participants will continue to exercise in their local gyms for 3 months. The study team will assist participants with application for a free (or discounted, funded by the study) gym pass via the Birmingham Be Active scheme. Participants will follow dietary restriction throughout the 4 months of the intervention and we aim for a decrease of 300-500 kcal.day-1 or 500-1000 kcal.day-1 as appropriate to initial BMI. The diet will be planned and modified (if needed) by a qualified clinical dietician. All outcome measures will be recorded 3 times except the biomarkers of joint remodelling and body composition only at baseline and 16 weeks. Finally, feasibility questionnaire and focus groups will be organised.
Participants focus group and feasibility questionnaire for ROH physio staff will be completed at the final assessment point (week 16).
Intervention type
Other
Phase
Drug names
Primary outcome measure
Feasibility assessed via focus group (participants) and questionnaire (ROH physio staff) at week 16.
Secondary outcome measures
1. Body weight, waist circumference and body mass index (BMI) are measured using standard anthropomorphic techniques at baseline, 4 and 16 weeks
2. Musculoskeletal function is measured at baseline, 4 and 16 weeks:
2.1. Knee range of motion is measured by goniometry
2.2. Lower limb muscle power is measured by Nottingham Power Rig
3. Physical performance is measured using a stair climb and timed up and go test at baseline, 4 and 16 weeks
4. Pain intensity is measured using WOMAC pain subscale at baseline, 4 and 16 weeks
5. Quality of life is assessed using the SF-36 questionnaire at baseline, 4 and 16 weeks
6. Body composition is measured by body impedance analysis; BIA at baseline and 16 weeks
7. Markers of joint remodelling are assessed by Blood samples analysis at baseline and 16 weeks
Overall trial start date
01/09/2016
Overall trial end date
30/11/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 06/06/2018:
1. Older adults (men and women aged 45-90 years)
2. Obese according to BMI ≥30 kg/m²
3. Not participating in regular exercise more than twice a week
4. Diagnosed with knee OA with or without radiographic evidence
Previous inclusion criteria:
1. Older adults (men and women aged ≥55 years)
2. Obese according to BMI ≥30Kg/m²
3. Not participating in regular exercise more than twice a week
4. Diagnosed with knee OA with or without radiographic evidence
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
30
Participant exclusion criteria
Current exclusion criteria as of 06/06/2018:
1. Significant co-morbid disease that would pose a safety threat or impair ability to participate such as coronary artery disease, severe hypertension, peripheral vascular disease, stroke, congestive heart failure, chronic obstructive pulmonary disease, insulin-dependent diabetes, psychiatric disease, renal disease, liver disease, active cancer other than skin cancer, advanced osteoporosis and anaemia
2. Previous acute knee injury (moderate-severe) which may restrict the participant
3. Neuromuscular impairments that preclude participating in physical activity, visual, hearing, or moderate/ severe cognitive impairments
4. Unwillingness to modify diet or physical activity patterns or inability to comply with the intervention because of inability to access a gym, food allergies or reactions to the meal replacement
5. Resting systolic blood pressure greater than 200 mmHg and resting diastolic blood pressure greater than 100 mmHg
Previous exclusion criteria:
1. Significant co-morbid disease that would pose a safety threat or impair ability to participate such as coronary artery disease, severe hypertension, peripheral vascular disease, stroke, congestive heart failure, chronic obstructive pulmonary disease, insulin-dependent diabetes, psychiatric disease, renal disease, liver disease, active cancer other than skin cancer, advanced osteoporosis and anaemia
2. Previous acute knee injury (moderate-severe) which may restrict the participant
3. Neuromuscular impairments that preclude participating in physical activity, visual, hearing, or moderate/ severe cognitive impairments
4. Unwillingness to modify diet or physical activity patterns or inability to comply with the intervention because of inability to access a gym, food allergies or reactions to the meal replacement
Recruitment start date
02/10/2017
Recruitment end date
20/07/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Royal Orthopaedic Hospital
Royal Orthopaedic Hospital NHS Foundation Trust
Bristol Road South
Northfield
Birmingham
B31 2AP
United Kingdom
Trial participating centre
University of Birmingham
School of Sport, Exercise and Rehabilitation Sciences
University of Birmingham Edgbaston Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Birmingham
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results of this trial will be submitted for publication in peer reviewed journals and the full study report can be accessed 6 months after completing the trial.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study will be available upon request from Dr. Carolyn Greig (c.a.greig@bham.ac.uk)
Intention to publish date
01/03/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN12906938_PIS_09Jan17_V1.3.docx Uploaded 12/01/2017
- ISRCTN12906938_PIS_v5_10Jan18.docx Uploaded 06/06/2018