Feasibility and Effectiveness of Concurrent Exercise Training on Frail Older Adults Living in Nursing Homes

Frailty Clinical Trial

Official title:

Feasibility and Effectiveness of a 12-week Concurrent Exercise Training on Physical Performance, Muscular Strength and Circulating Myokines in Frail Older Adults Living in Nursing Homes: a Cluster Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06380127
• Other study ID #: CEFADE012021
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: April 2024
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study is a crossover randomized controlled trial that aims to investigate the effects of concurrent exercise training over usual care on physical performance, muscle strength, and myokines concentrations in frail older adults living in nursing homes.The main questions it aims to answer is: Can a 12-week exercise intervention provide beneficial effects on physical performance, muscle strength and myokines among the most frail participants? Researchers will compare this intervention to usual care. Nursing homes (comprising participants) will be randomly assigned to a sequence of interventions (AB or BA), being A -exercise and B usual care. Participants will be assessed before and after each intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 15, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Classified as frail according to the Fried criteria (e.g., frailty phenotype = 3 criteria);
• Not having participated in any exercise intervention for the last 3 months;
• Being able to ambulate (with/without assistance).

Exclusion Criteria:

• Any contraindication that could affect physical exercise performance or testing procedures, including terminal illness, uncontrolled disease or other unstable medical condition;
• Bone fracture in the past three months;
• having a short physical performance battery score (SPPB) < 3.

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• Exercise training
The exercise intervention will take place at the nursing homes and consists of 12 weeks of supervised concurrent exercise training, performed thrice weekly on nonconsecutive days to avoid overtraining and fatigue. Each session will last 50-60 min and consist of a warm-up, resistance plus aerobic training, and a 5-min cool-down period. The resistance training will comprise 2-3 sets of 10 to 15 repetitions with a load equivalent to 40 to 70% of the 1-repetition maximum (1RM) for upper (i.e., bicep curl) and lower body exercises (i.e., seated knee extension). The sit-to-stand exercise will be performed as fast as possible according to each participant's capacity without external load. The recovery between sets is between 1 and 2 min. Afterwards, participants will perform walking exercises with changes in pace and direction. The duration of the aerobic training will progress from 5-10 min duration in the first weeks to 10-15 min. The sessions will end with stretching exercises.The exercise

Locations

Country	Name	City	State
Portugal	Faculty of Sports, University of Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline on Short Physical Performance Battery (SPBB)	The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).	Assessment at baseline and immediately after 12 weeks of intervention, in each period.
Secondary	Change from Baseline on Handgrip test	Handgrip strength will be obtained with a Jamar Plus + Digital hand dynamometer (Sammons Preston Inc., Bolingbrook, Illinois, USA).Measurements will be carried out following the American Society of Hand Therapists recommendations, and each participant will perform three attempts with a pause of 15s between trials	Assessment at baseline and immediately after 12 weeks of intervention, in each period
Secondary	Change from baseline on isokinetic knee strength	The dynamic concentric muscle strength of the knee flexors and extensors will be measured on an isokinetic dynamometer (Biodex System 4 Pro; Biodex, Shirley, NY).The measurements will follow the manufacturer's instructions for knee extension/flexion at the angular velocity of 60/s (1.05 rad/s). After a few repetitions for familiarization, each participant will perform three maximal repetitions at 60/s with their preferred leg.	Change from baseline and 12 weeks in each intervention, in both periods
Secondary	Change from Baseline on circulating levels of myostatin	Determination of myostatin levels in serum.	Change from baseline and 12 weeks in each intervention, in both periods
Secondary	Change from Baseline on circulating levels of Decorin	Determination of decorin levels in serum.	Assessment at baseline and immediately after 12 weeks of intervention, in each period