NCT05835297

Brief Summary

The aim of the study is to examine the effect of multicomponent exercises recommendations on falls, physical functioning, physical activity, and general physical and psychological well-being among Hungarian older adults dwelling in nursing homes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

May 25, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 9, 2025

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

April 17, 2023

Last Update Submit

January 7, 2025

Conditions

Keywords

FallExerciseElderlyGuidelineRiskFunctionality

Outcome Measures

Primary Outcomes (1)

  • Number of all falls (non-injurious and injurious)

    Whenever a fall occurred for any of the participants during intervention time, it will be recorded by the staff and reported on a fall incidence report. All fall will be reported; non-injurious (i.e., does not result in a physical harm), moderate injurious falls (i.e., result in bruising, sprains, cuts, abrasions, or reduction in physical function for at least three days, or if the participant sought medical help), and serious injurious falls (i.e., result in a fracture or admission to hospital with an injury or required stitches).

    During the 12-week of the intervention.

Secondary Outcomes (14)

  • Short Physical Performance Battery (SPPB)

    Baseline and 12th week.

  • Six-minute Walking Test (6MWT)

    Baseline and 12th week.

  • Timed Up and Go Test (TUGT)

    Baseline and 12th week.

  • Single Leg Stance Test (SLST)

    Baseline and 12th week.

  • Functional Reach Test (FRT)

    Baseline and 12th week.

  • +9 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

Physical exercise interventions for 45 min, twice a week plus usual care provided at the nursing home.

Other: Physical exercise interventions

Usual care

NO INTERVENTION

Usual care provided at the nursing home with no specific physical exercise intervention.

Interventions

Participants will undergo a 12-week multicomponent exercise regimen, twice per week on non-consecutive days for 45-60 min each. The session will be divided into 4 min of warm-up; range of motion exercises of upper and lower extremities, followed by light walking, then 8 min balance exercises, followed by 15 min strength exercises; two sets of 13-15 repetitions maximum of chair rises with progression, two sets of 13-15 repetitions of modified squats (holding a chair backrest if needed) with progression, 2 sets of 20-30 repetitions of seated or 2 sets of 13-15 repetitions of standing calf raises, then 15 min aerobic exercises; five 3-min bouts of walking between two strengthening exercises and/or 2 balance exercises, finally 3 min cool down exercises of light walking and stretching exercises.

Exercise group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Willingness to participate
  • Males and females aged ≥65 years living in nursing homes
  • Physically mobile (capable of ambulating/rising from chair with or without assistance)
  • Not under simultaneous physical activity/exercise investigation in other experimental studies or under other exercise rehabilitation programme
  • To be able to read and understand the self-reported assessments as well as follow the verbal instructions.

You may not qualify if:

  • Physically unable or medically unfit to participate in physical exercise after consultation of the responsible medical team
  • Score of \< 18 on mini-mental state examination (MMSE).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pécs

Pécs, Hungary

Location

Related Publications (2)

  • Sadaqa M, Debes WA, Nemeth Z, Bera-Baka Z, Vachtler-Szepesi M, Foldes LN, Premusz V, Hock M. Multicomponent exercise intervention for preventing falls and improving physical functioning in older adult nursing home residents: study protocol for a randomised controlled trial. BMC Public Health. 2025 Oct 2;25(1):3296. doi: 10.1186/s12889-025-24606-y.

  • Sadaqa M, Debes WA, Nemeth Z, Bera-Baka Z, Vachtler-Szepesi M, Naczine Foldes L, Premusz V, Hock M. Multicomponent Exercise Intervention for Preventing Falls and Improving Physical Functioning in Older Nursing Home Residents: A Single-Blinded Pilot Randomised Controlled Trial. J Clin Med. 2024 Mar 10;13(6):1577. doi: 10.3390/jcm13061577.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (PhD candidate)

Study Record Dates

First Submitted

April 17, 2023

First Posted

April 28, 2023

Study Start

May 25, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 9, 2025

Record last verified: 2024-03

Locations