Promoting Physical Activity Following Dysvascular Amputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest Park Healthcare Centre
About this trial
Loss of a lower limb due to diabetes can have a devastating impact on physical and mental health and quality of life. Individuals are at risk of other diseases such as cardiovascular disease, loss of the other limb and death. Physical activity can reduce risk of chronic disease and improve health outcomes; however, physical activity levels in people with limb loss are low, often due to reduced balance and walking ability. Rehabilitation services are not readily available and the cost of delivering such programs remains high. Working with individuals with lower limb amputation, we created a virtual, peer-led physical activity behaviour change intervention called IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3). We will conduct a pilot study to assess feasibility and optimize design of a future trial of effectiveness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Dysvascular LLA (LLA due to diabetes or vascular disease)
major LLA (at the ankle or above)
living in the community
adult at least 18 years of age
Disqualifiers
actively receiving rehabilitation services related to physical activity/mobility
recommended medical supervision for physical activity by health care provider, or skin problems preventing usual activity
not able to provide informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
IMPACT-L3
BehavioralThe intervention is a physical activity behaviour change intervention: IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3). Two theories provide a framework for IMPACT-L3. One is social cognitive theory and the other is self-determination theory. As mHealth solutions have the potential to increase access and improve health outcomes, IMPACT-L3 will be delivered entirely virtually.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: IMPACT-L3Experimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Consent rate: the percent of recruited individuals who provide consent per month.
Time frame
8 weeks2
Withdrawal Rate: the percent of study participants withdrawing by 9 weeks and 4 week follow-up
Time frame
enrollment to 13 weeks3
Peer coach adherence: total number of peer coaching sessions attended by the peer-trainer.
Time frame
enrollment to 8 weeks4
Participant and tester burden: the amount of time it took to administer study outcomes at T1, T2, and T3 and the acceptability of the evaluation time commitment from the perspective of participants.
Time frame
Baseline, end of intervention (week 9) and 4 week follow-upSecondary outcomes
1
Objective physical activity
A tri-axial accelerometer is a lightweight device used to measure total activity counts. The sum of the total count for the day will be used and averaged over the measurement period.
Time frame
Baseline, week 9, 4 week follow-up2
Self-efficacy for Exercise Scale
A self-report measure (9 items) that includes situations that may influence physical activity participation. Participants will respond to each item on a 0 (not very confident) to 10 (very confident) scale.
Time frame
Baseline, week 9, 4 week follow-up3
Self-Regulatory Efficacy for Exercise
8-item measure to assess participants' confidence in their ability to manage their exercise.
Time frame
Baseline, week 9, 4 week follow-up4
Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D will assess participant\'s self-rated depressive symptoms. It is a 20-item scale that refers to symptoms in the last week.
Time frame
Baseline, week 9, 4 week follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
West Park Healthcare Centre
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov