Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)

Background and rationale:

Chronic musculoskeletal pain is highly prevalent in older adults and is a major determinant of disability, functional decline and reduced health-related quality of life. Persistent pain is associated with lower physical activity, muscle weakness, impaired postural control, fear of movement and fear of falling, which together promote avoidance behaviours and increase the risk of falls. Structured exercise (e.g., the Otago Exercise Programme, multicomponent strength, balance and functional training) is effective in preventing falls in community-dwelling older adults, and pain science education combined with exercise is well accepted by older people with chronic pain. However, no protocol has yet been identified that systematically integrates fall-prevention multicomponent exercise with pain self-management, including pain science education, in community-dwelling adults aged 65 years or over who have both chronic musculoskeletal pain and an increased risk of falling. Dual-task (motor-cognitive) training is also included because chronic pain may amplify cognitive-motor interference during gait and balance.

Objectives:

General: to assess the feasibility, acceptability and safety of a multicomponent exercise programme combined with pain science education, compared with a control group, in community-dwelling older adults with chronic musculoskeletal pain, and to explore its preliminary effects on clinical and functional outcomes.

Specific: (1) to assess the feasibility of recruitment, randomisation, retention, adherence and safety; (2) to explore changes in functional mobility, balance, lower-limb function and fall-risk-related task performance; (3) to assess changes in pain intensity and interference, fear of falling, fear of movement and quality of life; (4) to produce preliminary effect size estimates to inform a future full-scale randomised controlled trial.

Design and setting:

Two-arm, parallel-group pilot randomised controlled feasibility trial, reported according to the CONSORT 2025 statement and the CONSORT extension for randomised pilot and feasibility trials. The intervention is delivered within the existing community programme +Idade +Saúde at the School of Education of the Universidade Politécnica de Bragança (UPB; formerly Instituto Politécnico de Bragança, IPB), Portugal, in the context of the LiveWell - Research Centre for Active Living and Wellbeing Internal Seed Project call (project title: ActiveAge-Fall: Exercise, Pain Management and Fall Prevention in Older Adults).

Sample size:

As a feasibility study, no formal power calculation was performed. A sample of 30-40 participants follows methodological recommendations for pilot and feasibility trials and will allow estimation of recruitment, adherence and retention rates and of the variability of clinical outcomes with sufficient precision to inform the sample size of a definitive trial.

Recruitment and baseline characterisation:

Participants are recruited through the +Idade +Saúde programme. After screening and written informed consent, baseline data are collected: sociodemographic data, clinical data (musculoskeletal diagnoses, pain duration and location, pain medication, comorbidities), anthropometry (weight, height, body mass index), body composition by bioimpedance (TANITA MC780P MA), habitual physical activity (IPAQ-SF, Portuguese version; used for characterisation only) and number of self-reported falls in the previous 12 months.

Randomisation and blinding:

After the baseline assessment, participants are individually randomised (1:1) using a simple computer-generated sequence (RStudio) held by an independent researcher, ensuring allocation concealment. Outcome assessors are blinded and are different from the instructors; data forms and databases are coded and randomisation codes remain concealed until database lock. Participants and instructors cannot be blinded.

Interventions:

Intervention group: 12-week supervised group programme with three 60-minute multicomponent exercise sessions per week (warm-up/joint mobility; progressive strength and power training organised in three 4-week mesocycles; challenging balance training; motor-cognitive dual-task training in three progressive phases; functional gait and activities-of-daily-living circuit; relaxation), designed according to the ICFSR international exercise recommendations for older adults (FITT parameters), plus one weekly 30-45-minute group session of pain science and fall-prevention education. Intensity is monitored with the Borg rating of perceived exertion (6-20) and repetitions in reserve; progression is individualised.

Control group: usual activities and routine care, without new supervised structured exercise; may be invited to attend the programme after the post-intervention assessment (waiting list).

Safety procedures: sessions delivered by physiotherapists/qualified professionals; attendance recorded at every session, with telephone contact after two consecutive absences; structured adverse event log; participants may stop any activity at any time.

Assessments:

Assessments are performed at baseline and immediately after the 12-week intervention by trained blinded assessors, using standardised protocols. Primary (feasibility) outcomes: recruitment, eligibility/consent, adherence, retention, adverse events and acceptability (PGIC and satisfaction questionnaire). Pre-specified feasibility success criteria: recruitment >=75% of target, mean adherence >=70% of sessions, retention >=80%, and no serious intervention-related adverse events, interpreted using a traffic-light (green/amber/red) approach for progression to a definitive trial. Exploratory clinical outcomes: TUG, TUG-DT and dual-task cost, 30-second Chair Stand Test, Mini-BESTest, isokinetic knee strength (HUMAC NORM, 60 and 180 deg/s), BPI-SF, Short FES-I, TSK-13 and WHOQOL-BREF.

Statistical analysis:

Analyses are performed in R (RStudio) according to a pre-defined plan, focusing on estimation rather than hypothesis testing. Feasibility outcomes are summarised descriptively (means/SD or medians/IQR; frequencies and percentages) with 95% confidence intervals for the main proportions. For clinical outcomes, within-group pre-post changes and exploratory between-group comparisons are estimated as mean differences with 95% confidence intervals and effect sizes, following the intention-to-treat principle whenever feasible, complemented by per-protocol analyses where relevant.

Ethics and data protection:

The study was approved by the Ethics Committee of the Universidade Politécnica de Bragança (opinion no. 2458328, 4 October 2026) and is conducted in accordance with the Declaration of Helsinki, the Oviedo Convention and the General Data Protection Regulation (GDPR). Participants are identified by numerical codes; data are stored in password-protected files accessible only to the research team. No financial rewards are given to participants.

Funding:

LiveWell - Research Centre for Active Living and Wellbeing, Internal Call for LiveWell's Seed Projects, Universidade Politécnica de Bragança (process no. P574305-R733916-D2398889).