The Adaptive Physical Activity Study for Stroke

NCT05606770 | Recruiting DMC

• 1 other identifier: ULimerick1
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

Despite recent advances in acute stroke intervention, secondary prevention strategies are lacking. Physical activity (PA) is the second largest predictor of stroke and the cornerstone of secondary prevention therapies. Adaptive interventions involve sequential treatments responsive to individuals' performance. Despite guidelines to adapt PA to individuals' needs, there is no evidence on the empirical development of adaptive PA interventions post-stroke. The evidence is dominated by standard trial designs, used to evaluate non-adaptive PA interventions. This trial will make original contributions to the literature by designing a first-in-class adaptive PA intervention using an innovative experimental design. This design will permit the delivery of optimal sequences of treatments to increase PA for individuals. Furthermore, by developing a user-informed smartphone application, this feasibility trial will lead to the design and evaluation of a highly-scalable definitive intervention to reduce the risk of recurrent stroke. Aim To use a Sequential Multiple-Assignment Randomised Trial (SMART) design to develop an adaptive, user-informed mobile health (mHealth) intervention to improve PA post-stroke. Subsequently this adaptive intervention will be evaluated against a treatment-as-usual control using a standard trial design in a definitive trial. Methods A co-design process was used to develop the technology platform for intervention delivery. There are two components which target increased PA in the current intervention: Structured Exercise and Lifestyle PA. The SMART will determine what sequence and/or combination of these intervention components produces the greatest increase in physical activity as measured by average daily step count. The primary outcome will be PA (steps/day), with clear feasibility and secondary clinical and cost outcomes. A SMART design will be used to evaluate the optimum adaptive PA intervention among people post-mild-to-moderate stroke.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Physical activity- mean steps/day over 7 days

  The primary outcome in this study is mean steps/day over 7 days measured using the Fitbit Charge 4 on the non-paretic limb.

  6 weeks post initial randomisation

Secondary Outcomes (15)

• Sedentary behaviour

  6 weeks post initial randomisation

• Fatigue

  6 weeks post initial randomisation

• Quality of Life post-stroke

  6 weeks post initial randomisation

• Anxiety and depression

  6 weeks post initial randomisation

• Re-integration into Normal Living

  6 weeks post initial randomisation

Study Arms (2)

Structured exercise

OTHER

Participants assigned to Structured Exercise will be provided with twice weekly strengthening exercise classes, delivered through the digital platform. The exercise classes will follow a circuit class style, in order to target a moderate-vigorous exercise intensity, in keeping with recent guidelines on secondary stroke prevention. Classes will include a full body warm up followed by a circuit of eight strengthening exercises completed for between one and three sets of 12 repetitions. Participants will be encouraged to exercise to fatigue on the 12th repetition of each set. This will be repeated for increasing sets and adding resistance through the use of resistance bands. During each session, participants will be reminded to reach their targeted weekly step count goals. The structured exercise component is informed by international clinical guidelines (Kleindorfer et al 2021 and Billinger et al 2021).

Behavioral: Structured Exercise

Lifestyle Physical Activity

OTHER

The Lifestyle PA component was developed using the Behaviour Change Wheel (BCW) Guide to Designing Interventions and is underpinned by the COM-B model of behavior change (Michie et al., 2014). This posits that people need capability(C), opportunity(O), and motivation(M) to perform a behavior(B). The aim of the Lifestyle PA component is to increase the capability, opportunity, and motivation of participants to reach their daily step count goals. To achieve this the 3 stages of the BCW intervention design process were followed. The first stage, understanding the behaviour, is done through a review of the literature and primary qualitative research(Cardy et al., 2022). This stage identifies the change objectives of the intervention. Stage 2 requires the selection of intervention functions and the policies that would support them. The final stage is defining the content of the intervention using behaviour change techniques (BCTs) and selecting their mode of delivery.

Behavioral: Lifestyle Physical Activity

Interventions

Structured Exercise BEHAVIORAL

Participants assigned to Structured Exercise will be provided with twice weekly strengthening exercise classes, delivered through the digital platform. The exercise classes will follow a circuit class style, in order to target a moderate-vigorous exercise intensity. Classes will gradually progress in intensity throughout the program. Classes will include a full body warm up followed by a circuit of eight strengthening exercises. This will be repeated for increasing sets and adding resistance through the use of resistance bands . Exercises will involve simple full body exercises and movements for each major muscle group. This will ensure that exercises that can be completed regardless of possible unilateral weakness or physical impairment. During each session, participants will be reminded to reach their targeted weekly step count goals. The structured exercise component is informed by international clinical guidelines (Kleindorfer et al 2021 and Billinger et al 2021).

Structured exercise

Lifestyle Physical Activity BEHAVIORAL

The Lifestyle PA component was developed using the Behaviour Change Wheel (BCW) Guide to Designing Interventions and is underpinned by the COM-B model of behavior change (Michie et al., 2014). This posits that people need capability(C), opportunity(O), and motivation(M) to perform a behavior(B). The aim of the Lifestyle PA component is to increase the capability, opportunity, and motivation of participants to reach their daily step count goals. To achieve this the 3 stages of the BCW intervention design process were followed. The first stage, understanding the behaviour, is done through a review of the literature and primary qualitative research(Cardy et al., 2022). This stage identifies the change objectives of the intervention. Stage 2 requires the selection of intervention functions and the policies that would support them. The final stage is defining the content of the intervention using behaviour change techniques (BCTs) and selecting their mode of delivery.

Lifestyle Physical Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years+
• Clinician-confirmed stroke- ischaemic or haemorrhagic subtype
• Living within 90km of University
• Person in the first 6 months post-stroke
• No longer receiving inpatient or outpatient or community-based physical activity rehabilitation
• modified Rankin Scale score of 0-3
• People post-stroke who are able to express their basic needs verbally
• Have access to relevant technology to enable mHealth intervention delivery
• Have cognitive capacity to provide informed consent
• Medical clearance for participation in the TAPAS programme.

You may not qualify if:

• Contraindications for undertaking physical activity e.g. safety, presence of unstable heart disease

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

University Hospital Limerick

Limerick, Limeick, V94P7X9, Ireland

RECRUITING

Related Publications (2)

• Rocliffe P, Whiston A, O' Mahony A, O'Reilly SM, O'Connor M, Cunningham N, Glynn L, Walsh JC, Walsh C, Hennessy E, Murphy E, Hunter A, Butler M, Paul L, Fitzsimons CF, Richardson I, Bradley JG, Salsberg J, Hayes S. The adaptive physical activity programme in stroke (TAPAS): protocol for a process evaluation in a sequential multiple assignment randomised trial. BMJ Open. 2025 Sep 14;15(9):e087016. doi: 10.1136/bmjopen-2024-087016.

  PMID: 40953869 DERIVED

• Carr E, Whiston A, O'Reilly S, O Donoghue M, Cardy N, Carter D, Glynn L, Walsh JC, Forbes J, Walsh C, McManus J, Hunter A, Butler M, Paul L, Fitzsimons C, Bernhardt J, Richardson I, Bradley JG, Salsberg J, Hayes S. Sequential multiple assignment randomised trial to develop an adaptive mobile health intervention to increase physical activity in people poststroke in the community setting in Ireland: TAPAS trial protocol. BMJ Open. 2024 Jan 18;14(1):e072811. doi: 10.1136/bmjopen-2023-072811.

  PMID: 38238182 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

sara hayes, PhD

CONTACT

0035361202062; sara.hayes@ul.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 7, 2022
• Study Start: September 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 24 months after trial completion, when all data have been analysed and the results papers have been published.

Locations

IE (1)