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Clinical Trials/NCT04084834
NCT04084834
Completed
N/A

Feasibility of a Web-based, Peer-supported Exercise Program for Patients With Hip and/or Knee Osteoarthritis

Diakonhjemmet Hospital1 site in 1 country31 target enrollmentOctober 9, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Diakonhjemmet Hospital
Enrollment
31
Locations
1
Primary Endpoint
Feasibility: time resources used by peer-supporters
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 9, 2019
End Date
June 1, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Diakonhjemmet Hospital
Responsible Party
Principal Investigator
Principal Investigator

Anne Therese Tveter

Physiotherapist, PhD

Diakonhjemmet Hospital

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

Outcomes

Primary Outcomes

Feasibility: time resources used by peer-supporters

Time Frame: baseline to 12 weeks

Time (hours/minutes) per participant-peer-support contact (frequency of contacts divided by total time used by peer-supporters).

Feasibility: time resources used on the exercise program delivery

Time Frame: baseline to 12 weeks

Time (hours/minutes) per week per participant used on web-based exercise program delivery.

Feasibility: time resources used on motivational messages delivery

Time Frame: baseline to 12 weeks

Time (hours/minutes) per week per participant used on motivational message delivery.

Feasibility: proportion of received exercise diaries

Time Frame: baseline to 12 weeks

Proportion of received exercise diaries (0-12 per participant).

Feasibility: proportion wearing the activity monitor

Time Frame: baseline

Proportion of participants providing activity monitor data (at least 4 days, including one weekend day, with minimum 10 hours recording per day) at baseline.

Feasibility: proportion completing treadmill test

Time Frame: baseline

Proportion of participants completing the indirect maximal cardiorespiratory exercise test according to test-protocol at baseline.

Eligible: proportion eligible

Time Frame: baseline

Proportion of potentially eligible participants approached that are invited.

Recruitment: proportion enrolled

Time Frame: baseline

Proportion of eligible patients enrolled.

Retention: proportion of enrolled participants

Time Frame: baseline and 12 weeks

Proportion of enrolled participants providing data at 12 week post-test.

Adverse events: number of adverse events

Time Frame: 12 weeks

Total number of adverse events (by cause if possible) evaluated by answers at post-test: The four questions addressing possible adverse events: 1) Have you carried out any type of treatment during the last 3 months? (With treatment we mean medication, physical exercise, self-management course or any alternative treatments) (yes/no), 2) If yes, have you experienced any adverse event as a result of the treatment? (yes/no). 3) If yes, which adverse events as a result of treatment? 4) In your opinion, which treatment(s) do you think the adverse event was/were caused by? (medication, physical exercise, self-management course, alternative treatments, other) (Elaborate).

Secondary Outcomes

  • Changes in objectively measured physical activity(baseline and 12 weeks)
  • Change in physical fitness (VO2 peak)(baseline and 12 weeks)
  • Change in Hip disability and Osteoarthritis Outcome Score (HOOS)(baseline and 12 weeks)
  • Change in Knee disability and Osteoarthritis Outcome Score (KOOS)(baseline and 12 weeks)
  • Change in Patient-specific functional scale (PSFS)(baseline and 12 weeks)
  • Change in self-reported physical activity (International Physical Activity Questionnaire-Short Form)(baseline and 12 weeks)
  • Change in self-reported physical activity (HUNT)(baseline and 12 weeks)
  • Change in self-reported pain intensity the last week(baseline and 12 weeks)
  • Change in self-reported fatigue the last week(baseline and 12 weeks)
  • Change in self-reported disease activity the last week(baseline and 12 weeks)
  • Change in Health-related quality of life (EQ-5D-5L)(baseline and 12 weeks)
  • Change in Arthritis Self-Efficacy Scale (ASES)(baseline and 12 weeks)
  • Change in exercise self-efficacy(baseline and 12 weeks)

Study Sites (1)

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