An interventional study of MovePainFall multicomponent exercise programme and Pain science and fall-prevention education in Chronic Pain, Musculoskeletal Pain and Accidental Falls, sponsored by Instituto Politécnico de Bragança. Not yet recruiting at 1 site in Portugal. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Instituto Politécnico de Bragança · Not applicable, Interventional, and Prevention
Chronic musculoskeletal pain is common in older adults and is associated with reduced mobility, loss of function, poorer quality of life, fear of movement, fear of falling and a higher risk of falls. Exercise programmes are effective in preventing falls, but very few programmes combine fall-prevention exercise with pain self-management, including pain science education, for older people who live in the community and have both chronic pain and an increased risk of falling.
The goal of this pilot randomised controlled feasibility trial is to find out whether it is feasible, acceptable and safe to deliver a 12-week supervised group programme (MovePainFall) that combines multicomponent exercise with pain science and fall-prevention education, compared with a control group that maintains usual activities, in community-dwelling adults aged 65 years or over with chronic musculoskeletal pain (lasting 3 months or more).
The main questions it aims to answer are:
Researchers will compare the MovePainFall group with the control group to estimate feasibility parameters and preliminary effect sizes that will inform the design and sample size of a future full-scale randomised controlled trial.
Participants in the MovePainFall group will:
Participants in the control group will maintain their usual activities and routine health care and may be invited to attend the programme after the post-intervention assessment (waiting list).
All participants will be assessed by blinded assessors before randomisation and after the 12-week intervention period.
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).
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 2,209 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Instituto Politécnico de Bragança is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Supervised group programme delivered by physiotherapists/qualified professionals within the community programme +Idade +Saúde (Polytechnic University of Bragança) for 12 weeks: three 60-minute multicomponent exercise sessions per week (warm-up and joint mobility; progressive strength and power training; challenging static and dynamic balance training; motor-cognitive dual-task training in 3 progressive phases; functional gait and activities-of-daily-living circuit; relaxation), plus one additional 30-45-minute group education session per week on pain neuroscience, pain self-management and fall prevention (12 sessions). Progression is individualised according to functional capacity, tolerance and symptom fluctuation.
Behavioral: MovePainFall multicomponent exercise programme · Behavioral: Pain science and fall-prevention education
Participants maintain their usual daily activities and routine health care throughout the study and are asked not to start any new supervised structured exercise programme during the intervention period. Relevant changes in physical activity, treatments or interventions for musculoskeletal pain are recorded. They undergo the same assessments, at the same time points and with the same blinded assessors as the intervention group, and may be invited to attend the MovePainFall programme after the post-intervention assessment (waiting list).
Supervised group multicomponent exercise, 3 sessions/week x 60 min for 12 weeks (36 sessions), based on ICFSR exercise recommendations (FITT), Otago principles and MultiMove motor-cognitive training. Each session: (i) warm-up/joint mobility, 5-10 min, Borg 9-11; (ii) strength and power, 15 min, 4-6 functional exercises, 1-3 sets x 8-12 reps, from 30-40% to 70-80% 1RM (Borg 12-13 to 15-17), with power training (40-60% 1RM, maximal intended concentric velocity) in weeks 9-12; (iii) challenging balance, 10-15 min, stations with reduced base of support, weight shifts, reduced sensory input and stepping strategies; (iv) motor-cognitive dual-task training, 10 min, 3 phases of increasing complexity (weeks 1-4, 5-8, 9-12); (v) functional gait and ADL circuit, 10 min, Borg 12-14; (vi) relaxation, 5-10 min, Borg \<11. Individualised progression; attendance and adverse events are recorded.
Group education session of 30-45 minutes once per week for 12 weeks (12 sessions), delivered in addition to the exercise sessions and always combined with exercise. Pain neuroscience content: neurophysiology of pain, nociception, pain versus tissue damage, peripheral and central sensitisation, neuroplasticity, fear-avoidance, pain and sleep, cognitions (catastrophising, fear, self-efficacy) and emotions, and self-management strategies (exercise, activity pacing, sleep hygiene, stress management). Fall-prevention content: intrinsic and environmental risk factors, the role of strength and balance exercise, safe gait and transfers, managing fear of falling and active-living strategies. Delivered with discussion of personal experiences, metaphors, diagrams, audiovisual and written materials, and information leaflets.
Recruitment rate
Number of participants recruited per month and proportion of the target sample (30-40 participants) recruited within the planned recruitment period. Pre-specified feasibility success criterion: \>=75% of the target sample recruited. Participant flow will be reported in a CONSORT 2025 flow diagram, adapted according to the CONSORT extension for pilot and feasibility trials.
Time frame: Recruitment period (approximately 2 weeks, before randomisation)
Eligibility and consent rates
Proportion of screened individuals who are eligible, and proportion of eligible individuals who consent to participate and are randomised (%, with 95% confidence intervals). Reasons for ineligibility and refusal will be recorded.
Time frame: Recruitment period (approximately 2 weeks, before randomisation)
Adherence to the intervention
Percentage of scheduled sessions attended (36 exercise sessions and 12 education sessions), per participant and overall, in the intervention group. Pre-specified feasibility success criterion: mean attendance \>=70% of sessions.
Time frame: During the 12-week intervention period
Retention
Proportion of randomised participants who complete the post-intervention assessment, and proportion of dropouts with reasons, in each group. Pre-specified feasibility success criterion: retention \>=80%.
Time frame: From randomisation to post-intervention assessment (approximately 16 weeks, including a 2-week holiday break)
Safety: adverse events
Number, type and severity of adverse events, reported as counts and rates per participant and per session, recorded in a structured safety log. Pre-specified success criterion: no serious intervention-related adverse events.
Time frame: From the start of the intervention to post-intervention assessment (approximately 16 weeks)
Acceptability: Patient Global Impression of Change (PGIC)
Participant-rated global impression of change in pain and function attributable to the exercise programme on the 7-point PGIC (Portuguese version; 1 = no change/worse to 7 = a great deal better), complemented by a brief study-specific satisfaction and acceptability questionnaire on the programme components.
Time frame: Post-intervention (within 2 weeks after completion of the 12-week intervention)
Change in functional mobility: Timed Up and Go (TUG)
Time (seconds) to rise from a chair, walk 3 m, turn 180 degrees, walk back and sit down. Lower values indicate better mobility.
Time frame: Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention)
Change in dual-task mobility: TUG with cognitive task (TUG-DT) and dual-task cost
TUG performed while serially subtracting 3 from a 3-digit number between 300 and 400 (seconds). Dual-task cost (%) = \[(TUG-DT - TUG single task) / TUG single task\] x 100; higher positive values indicate greater cognitive-motor interference.
Time frame: Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention)
Change in lower-limb function: 30-second Chair Stand Test
Number of complete sit-to-stand repetitions in 30 seconds. Higher values indicate better lower-limb function.
Time frame: Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention)
Change in balance: Mini-BESTest
European Portuguese Mini-BESTest, 14 items (anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait), total score 0-28. Higher scores indicate better balance.
Time frame: Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention)
Change in knee extensor and flexor muscle strength (isokinetic dynamometry)
Concentric peak torque (Nm), peak torque normalised to body mass (Nm/kg) and flexor/extensor ratio of the knee extensors and flexors at 60 deg/s and 180 deg/s, measured with a HUMAC NORM isokinetic dynamometer (CSMi).
Time frame: Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention)
Change in pain intensity: Brief Pain Inventory - Short Form (BPI-SF)
Portuguese BPI-SF pain severity score: mean of 4 items (worst, least, average and current pain), each rated 0-10. Higher scores indicate more severe pain.
Time frame: Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention)
Change in pain interference: Brief Pain Inventory - Short Form (BPI-SF)
Portuguese BPI-SF pain interference score: mean of 7 items (general activity, mood, walking, normal work, relations with others, sleep, enjoyment of life), each rated 0-10. Higher scores indicate greater interference.
Time frame: Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention)
Change in fear of falling: Short Falls Efficacy Scale-International (Short FES-I)
European Portuguese Short FES-I, 7 items rated 1-4, total score 7-28. Higher scores indicate greater concern about falling.
Time frame: Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention)
Change in kinesiophobia: Tampa Scale for Kinesiophobia (TSK-13)
Portuguese 13-item TSK, each item rated on a 4-point Likert scale, total score 13-52. Higher scores indicate greater fear of movement/(re)injury.
Time frame: Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention)
Change in health-related quality of life: WHOQOL-BREF
European Portuguese WHOQOL-BREF, 26 items rated on 5-point Likert scales; scores for the physical, psychological, social relationships and environment domains and 2 general items. Higher scores indicate better perceived quality of life.
Time frame: Baseline (before randomisation) and post-intervention (within 2 weeks after completion of the 12-week intervention)
Progression level achieved in the dual-task training block
Highest progression phase achieved (phase 1, 2 or 3) and modifications made, recorded by instructors on a standardised form for each participant in the intervention group.
Time frame: During the 12-week intervention period
Participants' perceptions of the education component (qualitative)
Qualitative data from a brief group interview at the end of the intervention exploring understanding of content, perceived usefulness, applicability of self-management strategies and satisfaction with the pain science and fall-prevention education. Analysed thematically.
Time frame: Post-intervention (within 2 weeks after completion of the 12-week intervention)
Plan to share: Yes — De-identified (anonymised) individual participant data underlying the results reported in publications (baseline characteristics, feasibility indicators and clinical outcomes), with the data dictionary, will be deposited in the institutional repository of the Polytechnic University of Bragança, in line with the study Data Management Plan, FAIR principles, GDPR and LiveWell guidelines, safeguarding participant confidentiality and the ethical and legal restrictions on sharing health data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning after publication of the main results (expected 2027-2028) and for at least 5 years thereafter, or as defined by the institutional repository policy.
Access criteria: Controlled access for researchers with a methodologically sound proposal, upon reasonable request to the principal investigator (marisalages@unipb.pt), subject to approval by the research team and, where applicable, the Ethics Committee, and to the signature of a data-use agreement. Data will be used for scientific purposes only (e.g., individual participant data meta-analyses, sample size calculation).
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 1,209 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 4 months is below that.
Counting every sponsor, half of 1,296 studies reached it within 21 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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