NCT07211334

Brief Summary

The assessment and systematic integration of physical activity into the care pathway of frail elderly people is essential to prevent loss of independence and improve the quality of life of this population. This project, which is part of routine care, aims to evaluate the practices and, in particular, the effects of different types of physical exercise currently in use at the Health and Sport Center of the Grenoble Alpes University Hospital. It therefore aims to optimize professional practices without changing the standard care provided to patients. Recommendations regarding intensity during cardiorespiratory endurance training sessions (moderate to high, taking into account emotional factors) are broad and vary greatly in their application depending on the facilities that work with older adults. This project aims to compare the exercise methods used on ergocycle at Health and Sport Center of Grenoble Alpes University Hospital: high-intensity interval training (HIIT) vs. moderate-intensity continuous training (MICT) to reverse the functional decline that occurs in frail older adults.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Dec 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress19%
Dec 2025Feb 2028

First Submitted

Initial submission to the registry

August 25, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 11, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

May 5, 2026

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

August 25, 2025

Last Update Submit

April 28, 2026

Conditions

Keywords

FrailtyElderlyHigh Intensity Interval TrainingModerate Intensity Continuous TrainingMotivation for Physical ActivitySupport for Changing Behavior Regarding Physical Activity

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory endurance (VO2peak)

    in mL/kg/min with an ergospirometer during a maximal progressive test

    At weeks 0, 8 and 24

Secondary Outcomes (7)

  • Fried's frailty criteria

    At weeks 0, 8 and 24

  • Weight

    At Weeks 0, 8 and 24

  • Height

    At weeks 0, 8 and 24

  • Body composition

    At weeks 0, 8 and 24

  • Health-related quality of life in its physical, psychological, and social dimensions

    At weeks 0, 8 and 24

  • +2 more secondary outcomes

Interventions

Adapted High Intensity Interval Training (HIIT), Moderate-Intensity Continuous training (MICT), therapeutic education workshops to help people become independent regarding their program

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged \>70 years are receiving routine care. They are identified as frail (3 positive criteria out of 5 according to Fried) or pre-frail (1 to 2 positive criteria out of 5 according to Fried) in the Geriatric Department of Grenoble Alpes Universitary Hospital (CHUGA) (Prof. Gavazzi) and are referred to the EXPLORASUD Sport and Health Center at CHU Sud (Dr. Coudurier, Dr. Doutreleau) for support through physical activity.

You may qualify if:

  • Adults aged 70 or older;
  • Patients meeting at least 1 of 5 frailty criteria (Fried criteria; 2001);
  • Patient does not object to the analysis of anonymized data;
  • Person affiliated with social security;
  • Patient's ability to use an ergocycle safely;
  • Patients medically stable patients with no acute illness or recent decompensation that could be aggravated by exercise (at the physician's discretion).

You may not qualify if:

  • Unstable medical conditions that may be aggravated by physical activity (as determined by a physician)
  • Musculoskeletal disorders and severe neurocognitive conditions that make it impossible to safely use the ergocycle or participate in the exercise program
  • individuals participating in other interventional studies or who have recently participated in an interventional study that could influence the results of this study
  • Persons referred to in Articles L1121-5 to L1121-8 of the public health code (corresponds to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to legal protection measures)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Grenoble alpes

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Frailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2025

First Posted

October 7, 2025

Study Start

December 11, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

May 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations