- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07817914
Feasibility of an Interval Running Exercise Program With Self-Regulated Unloading in Adults Aged 60 and Older
Feasibility and Preliminary Effects of an Exercise Model Based on Running Interval Training With Self-Regulated Unloading on Body Composition, Physical Fitness and Exercise Capacity, Muscle Strength, Pain Level, and Fall Risk in Adults Aged 60 and Older
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Regular physical activity is important for maintaining health and physical function in older adults. However, conventional exercise programs may be difficult to perform because of limited mobility, joint pain, concerns about injury, or other individual barriers. Short bouts of exercise combined with individually regulated joint unloading may provide a practical and adaptable approach for older adults. This pilot feasibility study will evaluate a novel self-regulated interval exercise program designed for adults aged 60 to 80 years. The program is inspired by the concepts of high-intensity interval training (HIIT) and exercise snacks, but is adapted to the individual physical abilities of older adults.
The intervention will last 4 weeks. Assessments will include adherence and adverse events monitoring, body composition analysis by a bioelectrical impedance method, lower-extremity muscle strength assessment using the five times sit to stand test (FTSST), aerobic capacity assessment by 2-minute step in place test (2MST), pain intensity assessment using numerical rating scale (NRS), and fall risk assessment using timed up & go test (TUG).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Lubusz Voivodeship
-
Nowa Sól, Lubusz Voivodeship, Polen, 67-100
- Wielospecjalistyczny Szpital Samodzielny Publiczny Zakład Opieki Zdrowotnej w Nowej Soli
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- age between 60-80 years
- written consent to participate in the study
Exclusion Criteria:
- unstable angina
- circulatory and respiratory failure
- implanted metal materials (e.g. defibrillator, pacemaker, stent)
- a mental disorder that makes it difficult to cooperate with medical personnel
- inability to safely perform exercise at an exertion corresponding to rating of perceived exertion (RPE) ≥ 14 on the 6-20 Borg scale
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Running Interval Training
|
The intervention will last 4 weeks.
Participants will perform four exercise sessions each day.
Each session will consist of five 1-minute periods of running or walking in place, separated by 20-second rest periods.
Gymnastic sticks will be used to allow participants to regulate the amount of weight placed through the lower extremities.
Participants will be able to increase or decrease the amount of support provided by the sticks according to their individual needs and comfort, thereby self-regulating the unloading of the lower-extremity joints.
The target exercise intensity corresponds to rating of perceived exertion (RPE) ≥ 14 on the 6-20 Borg scale
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility of the Exercise Program (proportion (%) of participants meeting the described feasibility criteria across 4 domains: adherence, retention, tolerability, and safety)
Zeitfenster: From baseline through post-intervention assessment following the 4-week intervention period
|
Feasibility will be assessed as the proportion (%) of participants meeting the following feasibility criteria across 4 domains: adherence, retention, tolerability, and safety.
Adherence: % of participants completing ≥75% of prescribed training days (weekly training recordings).
Green ≥75%, amber 50-74%, red <50%.
Retention: % completing intervention and post-assessment.
Green ≥80%, amber 60-79%, red <60%.
Tolerability: % with worsening in strength (Five Times Sit-to-Stand Test), aerobic capacity (2-Minute Step Test), or pain (Numeric Rating Scale).
Green ≤20%, amber 20-30%, red >30%.
Safety: % reporting minor adverse events and number of serious adverse events (SAE) (medical records).
Green <10% and no related SAE; amber 10-40% and no related SAE; red >40% or any related SAE.
Overall feasibility: all domains green = feasible without modification; any amber with no red = feasible after modification; any red = not feasible and requires major modification and further feasibility testing.
|
From baseline through post-intervention assessment following the 4-week intervention period
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Franciszek Pietraszkiewicz, University of Zielona Góra
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
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
- UZ/0015.37/2024
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .