NCT05957133

Brief Summary

Randomised clinical trial involving 58 independent subjects of both sexes who attended the Geriatric Revitalisation Programme run jointly by the University of Salamanca and the Salamanca City Council. At the beginning and at the end of the programme, data were collected on participants' balance, fall risk and other parameters, using anthropometric tests (weight, % body fat and body mass index (BMI)), and physical performance tests (grip strength, the Short Physical Performance Battery, TUG and the stair step test). Study participants performed three 50-minute sessions per week for a total of 35 weeks. The components of balance, gait, cardiovascular resistance, stability, upper and lower limb strength, flexibility and breathing exercises were worked on. In the OC group, the physiotherapist performed the entire session together with the participants, while in the other group, the physiotherapist simply ordered the exercises.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

July 31, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

July 11, 2023

Last Update Submit

July 19, 2023

Conditions

Keywords

exerciseelderlymulticomponent exerciseAction Observation

Outcome Measures

Primary Outcomes (1)

  • Short Physical Performance Battery (SPPB)

    Test to assess physical performance and degree of frailty consisting of 3 subtests: gait speed, balance, and lower limb strength. The maximum score is 12 points and a score ≤ 8 points indicates poor physical performance.

    thirty-five weeks

Secondary Outcomes (7)

  • Gait speed

    thirty-five weeks

  • Timed Up and Go (TUG)

    thirty-five weeks

  • Grip strength test

    thirty-five weeks

  • Chair stand test

    thirty-five weeks

  • Step-Up Box Test

    thirty-five weeks

  • +2 more secondary outcomes

Study Arms (2)

Multicomponent exercise group without action observation (MTG)

ACTIVE COMPARATOR

The main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises, playful activities or games are also included with some activities aimed at working on cognitive functions to reinforce the overall effects of the program, such as games with colors, numbers, letters, right-left laterality, memory, etc. The progression of the different models is as follows: E. Aerobic: Start with continuous work, then intervallic, and decrease rest times in intervallic work. E. Strength: Increase sets, repetitions and decrease rest time. Balance: start with static and evolve with blindfolds, perturbations, dynamic balance, etc. Coordination, and cognitive games will also become more complicated, with more complicated and faster decision making.

Procedure: Multicomponent exercise without action observation.

Multicomponent exercise group associated to action observation (AOG)

EXPERIMENTAL

It is the same intervention as the other group with the addition of the observation of actions thanks to the fact that the physiotherapist carries out the exercises with them at all times. The main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises, playful activities or games are also included with some activities aimed at working on cognitive functions to reinforce the overall effects of the program, such as games with colors, numbers, letters, right-left laterality, memory, etc. The progression of the exercises will be the same as in the other group.

Procedure: Multicomponent exercise associated with action observation

Interventions

Different exercise modalities are integrated: Aerobic, mobility, strength, balance and coordination exercises.

Multicomponent exercise group without action observation (MTG)

Different exercise modalities are integrated: aerobic, mobility, strength, balance and coordination exercises carried out at all times by the physiotherapist and observed by the participants.

Multicomponent exercise group associated to action observation (AOG)

Eligibility Criteria

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

You may qualify if:

  • adults over 65 years of age.

You may not qualify if:

  • Tumors
  • Pacemakers
  • Fibrillations
  • Cardiac pathology or uncontrolled hypertension
  • History of severe trauma/recent cervical surgery
  • Uncontrolled systemic and inflammatory pathologies
  • Congenital collagen compromise
  • Presence of difficulties in performing the Initial Evaluation tests
  • Language barriers
  • Pending litigation or legal claim

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Luis Polo Ferrero, MsC

CONTACT

Roberto Méndez Sánchez, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Single blind masking with blinded assessor.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Longitudinal prospective, controlled, single-blind study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 24, 2023

Study Start

July 31, 2023

Primary Completion

February 28, 2024

Study Completion

March 30, 2024

Last Updated

July 24, 2023

Record last verified: 2023-07