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Clinical Trials/NCT07741513
NCT07741513Not yet recruitingNot Applicable

Balance Workshops Focusing on Learning to Stand Up From the Floor for Older Adults Living at Home: A Pilot Study - Sol'Up

Centre Hospitalier Emile Roux1 site in 1 country80 target enrollmentStarted: September 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Feasibility of the intervention

Study Overview

Brief Summary

Falls among older adults are a major public health issue, accounting for approximately 2 million incidents annually in France, resulting in more than 10,000 deaths and 130,000 hospitalizations. Their cost is estimated at nearly 2 billion euros per year and is expected to rise as the population ages.

Falls result from multiple factors, including biological, behavioral, and environmental factors, with balance and gait disorders playing a central role. Their consequences include loss of independence, restricted activity, and fear of falling.

The ability to get back up from the ground after a fall is still largely overlooked. Yet up to two-thirds of older adults who have fallen are unable to get up on their own, exposing them to serious complications and an increased risk of further falls. This skill remains under-assessed and under-trained.

Physical activity-particularly programs combining balance, muscle strengthening, and functional training-can reduce the risk of falling by approximately 20 to 30 percent. Balance workshops are widely used for this purpose. However, these interventions primarily focus on fall prevention and rarely address fall management, particularly the ability to get up from the floor. Specific interventions targeting this skill are still underdeveloped, with mixed results.

The integration of structured training in getting up from the floor into balance workshops

Detailed Description

The primary objective of this study is to explore the feasibility and acceptability of integrating a soil survey training module into a balance workshop program for older adults living at home.

The secondary objectives of this study are to explore the potential effects of the program on certain functional and psychosocial dimensions among participants, by conducting an exploratory comparison between the intervention group and the control group.

The study will aim to assess:

  • the ability to get up from the floor;
  • functional mobility;
  • functional strength of the lower limbs;
  • postural balance;
  • confidence in balance during daily activities;
  • perceived self-efficacy for getting up from the floor;
  • level of physical activity;
  • the number of falls The feasibility of the intervention will be assessed based on the fidelity of its implementation: adherence to the content, the instructional progression, and the duration of the scheduled sessions. This aspect will be evaluated by the research team using a standardized monitoring form completed by the physical therapists.

The acceptability of the intervention will be assessed based on the following factors:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • People over the age of 65
  • Able to walk 100 m independently, with or without a walking aid (1 cane or 1 crutch)
  • Individuals who have fallen at least once in the past 12 months
  • Individuals who feel unsteady while standing or walking
  • Individuals who express a fear of falling
  • Individuals enrolled in the social security system or a similar program
  • Individuals who have been informed and have given their written consent to participate in the study

Exclusion Criteria

  • Refusal to participate in the study
  • Individuals who walk with two canes or a walker, or who are unable to walk
  • Medical contraindications to physical activity (cardiac conditions, acute illness, uncompensated vestibular disorder).
  • Major cognitive impairment or dementia preventing active participation.
  • Individuals with other contraindications, at the investigator's discretion
  • Recent orthopedic surgery (<3 months).
  • Major uncompensated sensory impairment

Outcomes

Primary Outcomes

Feasibility of the intervention

Time Frame: 6 months

The feasibility of the intervention will be assessed based on the fidelity of its implementation: adherence to the content. This aspect will be evaluated by the research team using a standardized monitoring form completed by the physical therapists.

Acceptability of the intervention

Time Frame: 6 months

The acceptability of the intervention will be assessed based on the following factors: • Participants' satisfaction with the program, measured using a satisfaction questionnaire administered at the end of the intervention. The satisfaction survey for participants in the control group alternates between multiple-choice questions (to assess overall satisfaction, sense of safety, trust built, and organization) and open-ended questions (to gather their personal feedback on the benefits, challenges they faced, and areas for improvement). The satisfaction survey for participants in the intervention group alternates between multiple-choice questions (to assess overall satisfaction, organization, sense of safety, and confidence regarding falls) and open-ended questions (to gather personal impressions on benefits, challenges, and areas for improvement).

Secondary Outcomes

  • Ability to stand up from the floor(at the beginning of the program (T0) and at the end (T1))
  • Functional mobility(at the beginning of the program (T0) and at the end (T1))
  • Functional lower-limb strength(at the beginning of the program (T0) and at the end (T1))
  • Postural balance(at the beginning of the program (T0) and at the end (T1))
  • Confidence in balance during daily activities(at the beginning of the program (T0) and at the end (T1))
  • Perceived self-efficacy for getting up from the floor(at the beginning of the program (T0) and at the end (T1))
  • Level of physical activity(at the beginning of the program (T0) and at the end (T1))
  • Number of falls(at the beginning of the program (T0) and at the end (T1))

Investigators

Sponsor
Centre Hospitalier Emile Roux
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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