Effect of LiFE-SePBT on Postural Stability in Community-dwelling Older Adults: an Assessor-blinded Randomised Controlled Trial (LiFE-SePBT)
Combined Effects of Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Training on Postural Stability in Community-dwelling Older Adults: an Assessor-blinded Randomised Controlled Trial
This study is an assessor-blinded randomised controlled trial investigating the effects of combined Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Training (LiFE-SePBT) on postural stability in community-dwelling older adults with an elevated risk of falling.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Participants will be randomly assigned to two groups: LiFE-SePBT or an attention control group. All participants will provide their written informed consent before baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenience sampling in the local community. After baseline assessment, both groups will receive five 90-minute intervention sessions over 10 weeks. Between-group differences in behaviour will be examined before and after training to identify immediate training-induced changes in postural stability. Retention of the changes in postural stability will be assessed four months after the training period. Fall incidents will be followed up for 12 months after training.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Bryan Tsz Lok Heung, Bsc
- Telefonnummer: +852-9210-2491
- E-Mail: 26119566r@connect.poly.hk
Studienorte
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Kowloon
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Hung Hom, Kowloon, Hongkong, 000
- Rekrutierung
- The Hong Kong Polytechnic University
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Kontakt:
- Bryan Tsz Lok Heung, Bsc
- Telefonnummer: +852-9210-2491
- E-Mail: 26119566r@connect.polyu.hk
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Community-dwelling older adults aged 60 or older
- Able to communicate effectively in Cantonese or Mandarin
- Able to walk independently on level ground for at least 30 minutes
- A score of ≥ 6 in the Abbreviated Mental Test (Hong Kong)
- Have fallen in the preceding year, have concerns about falling, or feel unsteady while walking or standing
Exclusion Criteria:
- Uncorrected vision or hearing impairment
- Osteoporosis
- Hip or knee replacement within the last year
- Resting blood pressure ≥ 160/100 mmHg even with medication taken
- A score of ≤ 6 in 5-items Geriatric Depression Scale (GDS-5)
- Have musculoskeletal, cardiovascular, mental, or neurological disorders that preclude their participation in the assessment or intervention safety
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: LiFE-SePBT
5 sessions of combined Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Training (LiFE-SePBT) will be delivered. The LiFE component involves having participants embed functional exercises into their lifestyle, as well as practising recovering their balance upon self-initiated perturbation. Each session is 90 minutes long and will be hosted once every 2 weeks. |
Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Exercise (LiFE-SePBT) is a synergistic fall prevention programme. LiFE programme targets generic balance and muscle strength whereas SePBT mainly influences through reactive balance. |
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Placebo-Komparator: Attention control group
Participants in the attention control group will receive 5 sessions of upper limb mobilisation and flexibility exercises. Each session is 90 minutes long and will be held once every 2 weeks. |
Upper limb mobilisation and flexibility training, including arm circles, deltoid stretches, shoulder internal rotations, etc. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Generic Balance ability
Zeitfenster: Week 0 (baseline assessment), week 10 (post-assessment), week 22 (i.e., 3-month follow-up assessment)
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Generic balance ability will be assessed by the Mini-BESTest. Mini-BESTest can challenge balance across anticipatory postural adjustments, postural responses, sensory orientation and stability in gait, allowing for a comprehensive examination of improvements that occur in reactive control. |
Week 0 (baseline assessment), week 10 (post-assessment), week 22 (i.e., 3-month follow-up assessment)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Number of real-life falls
Zeitfenster: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.
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The number of real-life falls in months after randomization will be recorded. Fall circumstances and related injuries will be required via phone contact. A fall is defined as an event resulting in a person unintentionally coming to rest on the ground or other lower level, not as the result of a major intrinsic event (e.g., syncope, stroke, or overwhelming hazard such as an earthquake). |
1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.
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Dynamic balance
Zeitfenster: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Dynamic balance will be assessed by Alternative Step Test (in the unit of seconds). |
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Balance confidence
Zeitfenster: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Balance confidence will be measured with the Chinese version of the shortened version of Activities-specific Balance Confidence Scale (ABC-6). The scale value is from 0 to 100, with higher values representing higher balance confidence. |
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Functional lower body strength
Zeitfenster: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Functional lower body strength will be assessed by Five-time Sit to Stand Test (in the unit of seconds). |
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Number of laboratory falls
Zeitfenster: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Participants will be exposed to one trip-like perturbation and slip-like perturbation on each foot at an unexpected time. The number of falls upon perturbations will be recorded. |
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Depressive symptoms
Zeitfenster: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Depressive symptoms will be assessed by Five-Item Geriatric Depression Scale. Participants will be asked to answer 5 questions as yes or no. The answer "no" for the first question and "yes" for the other four questions will be evaluated for depression. |
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Health-related quality of life
Zeitfenster: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Health-related quality of life will be assessed by the EQ-5D-5L. In the EQ-5D-5L descriptive system, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Each health state is identified by a five-digit code, with 11111 representing the best and 55555 the worst possible health state. |
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Muscle activations
Zeitfenster: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Muscle activations will be assessed by surface electromyography using an electromyography system (Trigno IM, Delsys Inc., Natick, MA, USA). Fourteen electrodes are placed bilaterally over erector spinae, rectus abdominis, gastrocnemius medialis, biceps femoris, rectus femoris, tibialis anterior, and gluteus medius according to the SENIAM guidelines (www.seniam.org) by the physical therapist. |
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Physical activity
Zeitfenster: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Physical activity will be assessed by the Physical Activity Scale for the Elderly. This questionnaire will ask participants to recall their activity over the last 7-days. Activity types include sitting, walking, sport/recreation, exercise, occupational and household. A total score for physical activity can be calculated using these answers and the predetermined weights associated with each activity. |
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Cognitive flexibility and executive function
Zeitfenster: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Cognitive flexibility and executive function will be assessed by Trial Making Tests A and B (in the unit of seconds). |
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Perceived ability to execute reactive stepping
Zeitfenster: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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The perceived ability to execute reactive stepping in different scenarios in real life situations via Short-Form Balance Recovery Confidence (SF-BRC) Scale. Each item is ranked from 0-10. |
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Exercise adherence
Zeitfenster: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Exercise adherence will be measured via the Chinese version of Exercise Adherence Rating Scale (EARS-C). The total score of this scale is ranked between 0 to 24; each item is graded from 0 to 4 while item 1, 4 and 6 are reverse-scored. |
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Charlotte Sau Lan Tsang, PhD, The Hong Kong Polytechnic University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- HSEARS20260330008
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Due to participant privacy concerns.
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