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

NCT04084834 | Completed

• 1 other identifier: 2018/2198-feasibility
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

Exercise

Outcome Measures

Primary Outcomes (10)

• Feasibility: time resources used by peer-supporters

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

  baseline to 12 weeks

• Feasibility: time resources used on the exercise program delivery

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

  baseline to 12 weeks

• Feasibility: time resources used on motivational messages delivery

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

  baseline to 12 weeks

• Feasibility: proportion of received exercise diaries

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

  baseline to 12 weeks

• Feasibility: proportion wearing the activity monitor

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

  baseline

• Feasibility: proportion completing treadmill test

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

  baseline

• Eligible: proportion eligible

  Proportion of potentially eligible participants approached that are invited.

  baseline

• Recruitment: proportion enrolled

  Proportion of eligible patients enrolled.

  baseline

• Retention: proportion of enrolled participants

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

  baseline and 12 weeks

• Adverse events: number of adverse events

  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).

  12 weeks

Secondary Outcomes (13)

• 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

Other Outcomes (9)

• Participant fidelity: proportion attending learning and mastery-course

  baseline to 12 weeks

• Participant fidelity (adherence): frequency of exercise

  baseline to 12 weeks

• Participant fidelity (adherence): frequency of exercise per week

  baseline to 12 weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

Participants allocated to the intervention group will be familiarized with exercise intensity levels (heart rate and Borg RPE) during the assessment at Diakonhjemmet Hospital. Further, the patients will be offered to take part in a 5-hour Learning and Mastery-course at Diakonhjemmet Hospital. Thereafter, the participants will get access to a web-based exercise program and guided to choose the appropriate exercise-level. Weekly, based on the individual progression, all participants will receive an exercise program by email consisting of individually tailored exercise sessions and motivational messages. At the end of each week, the participants complete an electronic exercise diary for monitoring adherence. All participants will be offered the possibility to seek peer-support; however, if preferred they may also follow the exercise program by themselves.

Other: Exercise

Interventions

Exercise OTHER

Participants will be offered to take part in a 5-hour Learning and Mastery-course at Diakonhjemmet Hospital, receiving information about the osteoarthritis disease, symptoms and the importance of exercise and physical activity. Participants will then be given a weekly web-based exercise program (12 weeks) consisting of three aerobic exercise sessions per week. The exercise program consists of five levels, and the participants will each week be guided to the most appropriate level based on their measured physical fitness level and the weekly exercise diary. The participants will at initial assessment at Diakonhjemmet Hospital be instructed to use Borgs scale to adjust exercise level. Based on the weekly exercise diary the participants will also get motivational messages by email.

Intervention group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Female gender is a predictor of osteoarthritis, so we expect that more women will be eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• The Norwegian Rheumatism Association: collaborator
• University of Melbourne: collaborator
• Extrastiftelsen: collaborator

Study Sites (1)

Diakonhjemmet Hospital

Oslo, 0319, Norway

Location

Related Publications (2)

• Joseph KL, Dagfinrud H, Hagen KB, Norden KR, Fongen C, Wold OM, Hinman RS, Nelligan RK, Bennell KL, Tveter AT. Adherence to a Web-based Exercise Programme: A Feasibility Study Among Patients with Hip or Knee Osteoarthritis. J Rehabil Med. 2023 Aug 14;55:jrm7139. doi: 10.2340/jrm.v55.7139.

  PMID: 37578100 DERIVED

• 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.

  PMID: 35859065 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anne Therese Tveter, PhD

  National Resource Center on Research in Rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD

Model Details: A pre-post single arm feasibility study

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: September 10, 2019
• Study Start: October 9, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)