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A pilot study of a healthy food guidance programme and an exercise therapy programme for people with hip and knee osteoarthritis and at least one other chronic condition.

He Oranga mo te Whanau: a Pilot Study on the Management of Osteoarthritis (MOA) and the Prediabetes Intervention Package (PIP) for people with hip and knee osteoarthritis and co-morbidities

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001330639
Acronym
MOA-PIP
Enrollment
12
Registered
2023-12-19
Start date
2024-01-22
Completion date
2024-02-16
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Exercise therapy, patient education, and weight loss when indicated are the first-line standard care recommended by international clinical practice guidelines for people with osteoarthritis. Many people with hip and/or knee osteoarthritis also have other chronic conditions, such as type 2 diabetes, prediabetes, heart disease and hypertension. Our previous research has demonstrated the effectiveness and feasibility of: a) an exercise programme for people with hip or knee osteoarthritis; and b) a primary care nurse-delivered healthy eating prediabetes intervention programme designed to facilitate regression to normoglycaemia for people with prediabetes and a body mass index greater than 25kg/m2. These two programmes have been combined and this pilot study seeks to determine recruitment rates and evaluate organisational processess associated with the study and the delivery of the combined exercise therapy and healthy eating intervention programme to facilitate the smooth running of the full study.

Interventions

The intervention will have two main components - a healthy food guidance programme and an exercise therapy programme. HEALTHY FOOD GUIDANCE and SUPPORT - THE PIP PROGRAMME This intervention will be delivered by trained primary care nurses and health coaches in the general practice setting. The purpose of the intervention is to deliver consistent evidence-based dietary messages to participants by their primary health care team. The focus of the intervention is to provide participants (and their

The intervention will have two main components - a healthy food guidance programme and an exercise therapy programme. HEALTHY FOOD GUIDANCE and SUPPORT - THE PIP PROGRAMME This intervention will be delivered by trained primary care nurses and health coaches in the general practice setting. The purpose of the intervention is to deliver consistent evidence-based dietary messages to participants by their primary health care team. The focus of the intervention is to provide participants (and their family/whanau) with an understanding of the principles of healthy eating, so they are empowered and able to make good food choices. That is, the dietary guidance and support will not be prescriptive. The pragmatic intervention package, designed and trialed previously in collaboration with primary care providers has five main components: 1. Health Professional Training and Support Primary care nurses and health coaches will undertake an intensive half-day training course on brief dietary assessment and guidance. The specific topics will include dietary assessments in the primary care setting using a New Zealand modified version of Starting the Conversation:Diet, internal and external factors affecting food choices, culture, behaviour change, goal setting and effective communication of dietary information. The course will be delivered by study investigators. A training manual will provide reference material, as well as research protocols. A 2-hour update course will be run at 6-months. A research nurse will visit participating practices monthly to review intervention delivery processes and to provide support and advice, as needed, in order to maximise intervention fidelity. Fidelity will be reviewed at monthly practice visits. All participating primary care nurses will be instructed on standard practices for measuring anthropometry and blood pressure. Practice equipment will be calibrated. 2. Individual Patient Education All eligible participants will be offered an initial 30 minute individual dietary session with the primary care nurse. They will be asked to complete a brief dietary assessment (Starting the Conversation:Diet modified to the New Zealand context.) at their first appointment. They will be encouraged to bring family/whanau to the session. Two to three goals will be determined and they will be given individualised dietary advice tailored to their situation based on a set of structured questions and the brief dietary assessment. They will be provided with appropriate written resources. Fifteen minute follow-up sessions will be delivered by health coaches or practice nurses at 1-2 weeks, 5-6 weeks, 3 months, 4 months and 6 months. Ongoing follow-up will be provided at 3-monthly intervals for a ‘weigh-in’ and to provide brief targeted dietary advice and support. If a participant has a healthy weight, and good dietary habits, then they may not complete all six visits. This will be at the discretion of the primary care nurse or health coach following the first appointment. 3. Goal Setting & Key Messages Two to three individually tailored dietary goals determined between the primary care nurse and patient (based on the structured questions and brief dietary assessment) will be incorporated into the general practice patient management systems (PMS). These messages will facilitate opportunistic targeted advice and guidance by GPs, thus reinforcing information provided at primary care nurse dietary consultations. The goals/messages will be reviewed and updated accordingly at the follow up appointments. 4. Nutritionally supportive primary care environment The dietary information provided in pamphlets, magazines and posters in participating general practice waiting rooms will be reviewed, and updated so that consistent appropriate dietary messages are reinforced within the primary care environment. 5. Written Resources The main written patient resource used will the Diabetes New Zealand “Diabetes and healthy food choices” pamphlet. EXERCISE THERAPY PROGRAMME The exercise therapy programme will commence after the second PIP visit and will take place concurrently with the remaining PIP intervention visits thereafter. The exercise programme consists of twelve 50-60 minute exercise therapy sessions with a trained physiotherapist. The first session will be individual (one to one); subsequent visits may be individual (one to one) or supervised group exercise therapy, depending on each participant’s preference. The sessions will take place at either a community physiotherapy clinic or, in the case of group sessions, at a community location, such as a community hall, sport venue or public park. The exercise therapy protocols include land-based functional strength and neuromuscular coordination exercises, which have been specifically designed to use minimal equipment, be readily delivered in outpatient or primary care settings and transferable to group and home use. The exercise therapy programme was co-designed with the physiotherapists who are going to deliver the programme. This occurred during 3 development/training sessions (of 3-4 hours duration) with input from a Maori community exercise consultant. The development was based on existing evidence-based interventions (Management of Osteoarthritis (MOA) and GLA:D (gladinternational.org)), which were adapted for the local context and population for this study. At the beginning of the programme, each participant will be given a booklet describing the programme principles and each exercise (a warm-up section with four different options plus seven exercise sections or stations). Each exercise has 4 levels of difficulty, along with tips on how to make each level a little more, or a little less, challenging. Each of the 12 exercise-therapy programme sessions will consist of three parts: a warm-up (3-5 minutes of any one of four options from the ‘warm-up’ section of the booklet), followed by two or more sets of each of the 7 standardised but individualised exercises. Exercises include: 1. Calf muscle strengthening; 2. Outer hip muscle strengthening; 3. Trunk muscle strengthening; 4. Knee extensor muscle strengthening, functional movements (e.g. knee extension in sitting and chair stands); 5. Lunges; 6. Backwards walking for neuromuscular coordination and muscle lengthening; and 7. Hip extensor muscle strengthening (e.g. extension in standing and ‘bridging’ pelvic lifts). Each exercise is progressed within and between levels with the intention that participants find the exercises at least moderately difficult and ideally ‘hard’ to ‘very hard’ based on the Borg rate of perceived exertion scale (i.e. between 4 and 8-or-9 on a scale from 1 to 10) whilst avoiding undue joint pain exacerbation during or following exercise sessions (pain increase to >5/10 or lasting longer than 24 hours), ideally returning to day-to-day symptoms within 24 hours. Participants will be counselled to expect some muscle soreness (explained as distinct from joint pain) that may last more than 48 hours. These principles will be explained to participants during the first one-to-one sessions with further explanations and information in the exercise booklet provided. The 12 exercise therapy sessions will take place over one year, beginning with an initial block of nine supervised sessions over a 7 week period. This is referred to as the ‘loading dose’ with the intention of also guiding participants toward independent self-management. This will followed by two booster sessions at 6 months and one at 11 months. Each participant’s performance of the exercises will be assessed during each supervised session, in which the physiotherapist will provide recommendations to each participant on what level to start each exercise station at – that is,. exercise difficulty will be individualised. Exercise difficultys will then be progressed or regressed based on guidance from the booklet resources and/or the supervising physiotherapist, where applicable. Adherence to the intervention by participants will be monitored by the supervising physiotherapist verbally at each intervention session, and through assessment of each participant’s goal achievement. All participants, whether one to one or group exercise, will be encouraged to continue to do exercise sessions, or their chosen form of alternative exercise, at least twice a week for the duration of the trial and beyond.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
35 Years to 74 Years
Healthy volunteers
No

Inclusion criteria

A clinical diagnosis of osteoarthritis using the established National Institute for Health and Care Excellence (NICE) (www.nice.org.uk/guidance/ng226/chapter/Recommendations#diagnosis) or the American College of Rheumatology (ACR) criteria, and at least one of the following: - type 2 diabetes, - pre-diabetes, - heart failure, - coronary heart disease (CHD), - hypertension, - chronic obstructive pulmonary disease (COPD), or - mild-to-moderate depression.

Exclusion criteria

* Participation in supervised systematic exercise for hip or knee osteoarthritis or a chronic condition within the last 3 months, * Pregnancy, * An unstable health condition or at risk of serious adverse events from land-based exercise, * Life expectancy of less than 12 months, * Major depression or other major mental illness * Not independently mobile in the community, * Not willing or available to participate for the intervention duration, * Unable to comprehend the recruitment or intervention processes (with an interpreter or assessor reading assistance provided, if required), * Planning to move prior to completing the study treatment programme..

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026