Effectiveness of a Multi-component Physical Exercise Online

NCT05895760 | Completed DMC

• 2 other identifiers: SALUD-2021-PHYSICAL EXERCISE35/2020
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: to assess the effectiveness of a multi-component physical exercise online intervention (MPE) on physical performance (PP) in community-dwelling older adults. Methods: a randomized controlled trial, including 110 older adults (68.45±5.54 years), were divided into two parallel groups: an MPE group (n = 55) and a control group (n = 55). The exercise program included endurance, strength, coordination, balance, and flexibility exercises which were carried out for 3 months. The control group received educational sessions on health prevention related to physical exercise. The main endpoint was a change in PP assessed with the short physical performance battery (SPPB). It is also evaluated other variables such as sociodemographic (sex, age, education level), health conditions (cognitive impairment, polypharmacy, comorbidity, frailty, sarcopenia, depressive and anxiety symptoms), functional dependence through scales of activities of daily living (ADL), nutrition (risk of malnutrition, weight, height, body mass index (BMI), calf and waist circumference) and lifestyles (physical activity, alcoholism, and smoking). Comparisons were made in the follow-up measurements between groups by an independent t-test and baseline and follow-up measurements in both groups by a paired t-test.

Conditions

Older Adults

Keywords

older adults; multi-component physical exercise; online; physical performance

Outcome Measures

Primary Outcomes (1)

• Physical performance

  Physical performance was assessed with an short battery physical performance which is an instrument that evaluates three domains of physical performance: balance, gait speed, and lower limb strength to rise from a chair.

  3 months

Study Arms (2)

Multi-component physical exercise online intervention (MPE)

EXPERIMENTAL

The exercise program included endurance, strength, coordination, balance, and flexibility exercises which were carried out for 3 months.

Other: Multi-component physical exercise online intervention

Control group

NO INTERVENTION

The control group received educational sessions on health prevention related to physical exercise.

Interventions

Multi-component physical exercise online intervention OTHER

A multicomponent exercise program was implemented consisting of a combined program of endurance, strength, coordination, balance, and flexibility exercises depending on the level of functional capacity. Three types of physical exercise programs were designed according to the physical performance level of each participant. The first type of exercise program training was performed for frail adults with an SPPB score of 4 to 6, the second was for the pre-frail adults with an SPPB score of 7 to 9 and the third for robust adults with an SPPB of 10 to 12.

Multi-component physical exercise online intervention (MPE)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Gender Eligibility Details: The participants were randomly selected regardless of gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 60 and over years
• Adults who had an electronic device with internet access for video calls.

You may not qualify if:

• Adults self-reported walking disability, with the inability to complete the short physical performance battery (SPPB)
• Adults with severe functional dependence (defined as a Barthel index ≤ 60/100 score)
• Adults with cognitive impairment (defined as a mini-mental state examination (MMSE) score \<24/30)
• Adults with terminal illness
• Adults who were participating in a physical activity or nutritional program
• Adults with a limb loss or use of lower or upper limb prostheses
• Adults with a history of injuries (fractures/falls) of less than one year in hip, knee or ankle joints and with surgery in the last 6 months or contraindications to perform trial activities in the judgment of medical personnel.
• Adults who presented any medical condition or adverse symptoms during the intervention that made it impossible to carry out the physical exercise program
• Adults who did not keep three times consecutive were eliminated from the study.

Sponsors & Collaborators

• Universidad Iberoamericana A.C., Mexico: lead

Study Sites (1)

Iberoamerican University

Mexico City, Mexico City, 01290, Mexico

Location

Study Officials

• Miriam Teresa López Teros, PhD

  Universidad Iberoamericana, A.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled trial, including 110 older adults (68.45±5.54 years), were divided into two parallel groups: an MPE group (n = 55) and a control group (n = 55).

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: June 9, 2023
• Study Start: June 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 31, 2021
• Last Updated: June 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The information will be protected by the principal investigator
• Access Criteria: The information will only be shared with co-investigators of the project and for research purposes.

Locations

ME (1)