A combined programme of dietary restriction and physical activity in people with osteoarthritis of the knee
| ISRCTN | ISRCTN12906938 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12906938 |
| Secondary identifying numbers | ERN_16-1432 |
- Submission date
- 06/01/2017
- Registration date
- 12/01/2017
- Last edited
- 21/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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)
Contact information
Scientific
School of Sport, Exercise and Rehabilitation Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0002-5572-8897 |
|---|
Public
School of Sport, Exercise and Rehabilitation Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Single-centre feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN12906938_PIS_09Jan17_V1.3.docx |
| 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 |
| Study acronym | DRPA |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2016 |
| Completion date | 30/11/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 35 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/10/2017 |
| Date of final enrolment | 20/07/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Bristol Road South
Northfield
Birmingham
B31 2AP
United Kingdom
University of Birmingham Edgbaston Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.birmingham.ac.uk/index.aspx |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1.3 | 09/01/2017 | 12/01/2017 | No | Yes |
| Participant information sheet | version v5 | 10/01/2018 | 06/06/2018 | No | Yes |
| Protocol article | protocol | 14/12/2018 | 06/11/2019 | Yes | No |
| Results article | results | 01/12/2020 | 30/01/2020 | Yes | No |
| Other publications | systematic review and mixed method data synthesis | 08/06/2017 | 21/02/2023 | Yes | No |
| HRA research summary | 26/07/2023 | No | No |
Additional files
- ISRCTN12906938_PIS_09Jan17_V1.3.docx
- Uploaded 12/01/2017
- ISRCTN12906938_PIS_v5_10Jan18.docx
- Uploaded 06/06/2018
Editorial Notes
21/02/2023: Publication reference added.
30/01/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
06/11/2019: Publication reference added.
06/06/2018: The following changes have been made:
1. The scientific title has been changed from "The effect of a combined programme of dietary restriction and physical activity on the physical function and body composition of obese elders with knee OA: Feasibility study" to "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".
2. HRA approval of protocol 6.0 has been added to the ethics approval section.
3. The interventions have been changed.
4. The overall trial end date has been changed from 01/09/2017 to 30/11/2018.
5. The participant inclusion criteria have been changed.
6. The participant exclusion criteria have been changed.
7. The recruitment start date has been changed from 01/03/2017 to 02/10/2017.
8. The recruitment end date has been changed from 01/05/2017 to 20/07/2018.
9. The intention to publish date has been changed from 01/03/2018 to 01/03/2019.
10. The plain English summary has been updated to reflect the changes above.
11. An updated participant information sheet has been uploaded.
22/09/2017: Internal review.
05/09/2017: Ethics approval information has been added.
12/01/2017: The participant information sheet has been uploaded.
