Clinical trial NCT04084834: Feasibility of a Web-based, Peer-supported Exercise Program for Patients With Hip and/or Knee Osteoarthritis
Official title: Feasibility of a Web-based, Peer-supported Exercise Program for Patients With Hip and/or Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Exercise
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: The Norwegian Rheumatism Association
name: University of Melbourne
name: Extrastiftelsen
First posted: 2019-09-10
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A pre-post single arm feasibility study
Primary purpose: TREATMENT

Brief summary: In this project, a web-based exercise program is developed in co-creation between specialized health care, the Norwegian Association for Rheumatic diseases (NRF) and a group of experienced patient representatives. The project emerges from the evidence that exercise is recommended as first-line treatment for patients with chronic diseases like hip- and knee-osteoarthritis (OA). However, the number of patients in need of targeted exercise will increase considerably the next decades, and their treatment needs cannot be fully handled within the health care system. Development of innovative and effective treatment trajectories and follow-up strategies is urgently required. Peer-support is recognized as an effective way to increase patients' long-term adherence to exercise. Thus, patient-organizations may be an unutilized resource in support and follow-up of patients who need long-term exercise as part of their treatment plan. After discharge from examination in hospital, patients with hip/knee OA will be recruited to follow-up in a novel web-based, peer-supported exercise program, and the feasibility of the intervention will be evaluated.

Detailed description: The study will be conducted as a pre-post single-arm feasibility study comprising 50 participants.

The main objective of the study will be to evaluate the feasibility of the web-based, peer-supported exercise intervention in patients with hip and/or knee OA.

Specific research objectives are:

* to assess feasibility of intervention delivery, data collection, eligibility and inclusion/exclusion criteria and intervention fidelity
* to assess the responsiveness of relevant primary and secondary outcome measures

In the feasibility study, all participants will be allocated to an intervention group, receiving a 12-week web-based, peer-supported aerobic exercise program including weekly motivational messages. Patients between 40 and 80 years of age that are not candidates for surgery will be recruited from Diakonhjemmet Hospital, Oslo, Norway.

To assess and evaluate feasibility, we will report on descriptive statistics. Responsiveness will be assessed using Receiver Operating Curve (ROC) analyses.

Eligibility criteria: Inclusion Criteria:

• patients with hip and/or knee osteoarthritis being referred to Diakonhjemmet Hospital

Exclusion Criteria:

* candidate for surgery
* unable to understand or write Norwegian
* unable to walk unaided and continuously for 15 minutes
* absolute or relative contradictions to maximal exercise testing
* have relatives with sudden death before 40 years of age
* have first-degree relatives with hypertrophic cardiomyopathy

Primary outcomes:
measure: Feasibility: time resources used by peer-supporters
timeFrame: baseline to 12 weeks
measure: Feasibility: time resources used on the exercise program delivery
timeFrame: baseline to 12 weeks
measure: Feasibility: time resources used on motivational messages delivery
timeFrame: baseline to 12 weeks
measure: Feasibility: proportion of received exercise diaries
timeFrame: baseline to 12 weeks
measure: Feasibility: proportion wearing the activity monitor
timeFrame: baseline
measure: Feasibility: proportion completing treadmill test
timeFrame: baseline
measure: Eligible: proportion eligible
timeFrame: baseline
measure: Recruitment: proportion enrolled
timeFrame: baseline
measure: Retention: proportion of enrolled participants
timeFrame: baseline and 12 weeks
measure: Adverse events: number of adverse events
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in objectively measured physical activity
timeFrame: baseline and 12 weeks
measure: Change in physical fitness (VO2 peak)
timeFrame: baseline and 12 weeks
measure: Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: baseline and 12 weeks
measure: Change in Knee disability and Osteoarthritis Outcome Score (KOOS)
timeFrame: baseline and 12 weeks
measure: Change in Patient-specific functional scale (PSFS)
timeFrame: baseline and 12 weeks
measure: Change in self-reported physical activity (International Physical Activity Questionnaire-Short Form)
timeFrame: baseline and 12 weeks
measure: Change in self-reported physical activity (HUNT)
timeFrame: baseline and 12 weeks
measure: Change in self-reported pain intensity the last week
timeFrame: baseline and 12 weeks
measure: Change in self-reported fatigue the last week
timeFrame: baseline and 12 weeks
measure: Change in self-reported disease activity the last week
timeFrame: baseline and 12 weeks
measure: Change in Health-related quality of life (EQ-5D-5L)
timeFrame: baseline and 12 weeks
measure: Change in Arthritis Self-Efficacy Scale (ASES)
timeFrame: baseline and 12 weeks
measure: Change in exercise self-efficacy
timeFrame: baseline and 12 weeks
Other outcomes:
measure: Participant fidelity: proportion attending learning and mastery-course
timeFrame: baseline to 12 weeks
measure: Participant fidelity (adherence): frequency of exercise
timeFrame: baseline to 12 weeks
measure: Participant fidelity (adherence): frequency of exercise per week
timeFrame: baseline to 12 weeks
measure: Participant fidelity (adherence): frequency of exercise weeks
timeFrame: baseline to 12 weeks
measure: Participant fidelity (adherence): duration of exercise sessions
timeFrame: baseline to 12 weeks
measure: Participant fidelity (adherence): intensity of exercise sessions
timeFrame: baseline to 12 weeks
measure: Use of health care resources due to musculoskeletal pain
timeFrame: baseline
measure: Use of medication due to musculoskeletal pain
timeFrame: baseline
measure: Osteoarthritis pain on a Global Rating of Change scale
timeFrame: 12 weeks
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: National Resource Center on Research in Rheumatology
name: Anne Therese Tveter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joseph KL, Dagfinrud H, Hagen KB, Norden KR, Fongen C, Wold OM, Hinman RS, Nelligan RK, Bennell KL, Tveter AT. The AktiWeb study: feasibility of a web-based exercise program delivered by a patient organisation to patients with hip and/or knee osteoarthritis. Pilot Feasibility Stud. 2022 Jul 20;8(1):150. doi: 10.1186/s40814-022-01110-3.