Physical Fitness, Sleep Quality, Dynamic Balance and Exercise in Aged People

NCT06646380 | Completed

• 1 other identifier: 501020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Nowadays, the sedentary lifestyles and aging related problem to well-being, have a significant impact on of physical fitness, quality of life, and sleep in elderlies. The regular exercise is of higher importance crucial for maintaining overall health and delay some ageing-related declines in physical fitness. The multicomponent training (MCT) programs, include exercises to promote endurance, strength, flexibility, and balance. The MCT are typically effective to improve physical fitness, quality of life, sleep, and balance in older populations. Notably, in visually impaired older adults, lower limb function is closely linked to fall risk. Improving the muscular strength and bone health enhances the balance and the gait. Additionally, it is possible to find associations between sleep quality, frailty, and quality of life among older adults, highlighting the interplay between sleep, physical health, and overall well-being in aging populations. Another study, highlighted that the socioeconomic status and sleep quality's influence on the prevalence of multimorbidity in older adults, underscoring the broader health implications of sleep disturbances in aging populations. The principal objective of the current PhD research project is to assess the effects of a multicomponent training programs on critical variables such as physical fitness, sleep quality, and dynamic balance in older adults.

Conditions

Aged 60 Years or Older; Aged Healthy Volunteer

Keywords

aged; physical fitness; body composition; sleep quality

Outcome Measures

Primary Outcomes (1)

• Sleep Quality

  Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire developed by and validated for the Portuguese population. The PSQI items are divided into the following components: 1) subjective sleep quality, 2) sleep latency, 3) sleep duration, 4) habitual sleep efficiency, 5) sleep disturbances, 6) use of sleeping medication, and 7) daytime dysfunction. Each item is scored from 0 to 3, with the total score ranging from 0 to 21; higher scores indicate more severe sleep disturbances. A global score of 5 or higher in two components signifies significant sleep difficulties, while a score in three or more components indicates moderate sleep issues. A total score below 5 indicates good sleep quality, whereas a score above 5 indicates poor sleep quality.

  At baseline (0 weeks) and at 32 weeks

Secondary Outcomes (16)

• Handgrip strength

  At baseline (0 weeks) and at 32 weeks

• 2-Minute Step Test

  At baseline (0 weeks) and at 32 weeks

• The Seat-to-Stand Test

  At baseline (0 weeks) and at 32 weeks

• Arm Curl Test

  At baseline (0 weeks) and at 32 weeks

• Time-Up-and-Go Test

  At baseline (0 weeks) and at 32 weeks

Study Arms (2)

Multicomponent Training

EXPERIMENTAL

Participants will be instructed to maintain normal daily life activities to prevent physical inactivity. Inclusion criteria will involve individuals over 65 years old, independent in daily activities, and without chronic diseases requiring pharmacological treatment affecting the experimental protocol, while exclusion criteria included failure to attend more than 25% of training sessions, failure to attend more than four consecutive sessions, or missing evaluation sessions. Participants will be randomly assigned to either the experimental group (EG ≈ 30) or control group (CG ≈ 30). Experimental group will be followed-up during the exercise sessions.

Behavioral: Multicomponent Training

Control Group

PLACEBO COMPARATOR

The CG were instructed to maintain their daily life routines. However, the typical profile of this group was that the participants were regularly physically active people. Most participate in municipal activities like nature walking, physical activity sessions including dance (casually), board and card games, and traditional games (Bocce, Adapted Bowling, and darts).

Other: Maintenance

Interventions

Multicomponent Training BEHAVIORAL

The multicomponent training (MCT) program comprised aerobic, resistance, flexibility, and balance exercises, following recommendations by Carvalho et al. (23). Sessions lasted 50 to 60 minutes, including warm-up, aerobic exercise, resistance training, balance training, and cool-down. Training intensity gradually increased over time. The experimental group will have three 60-minute sessions weekly for 32 weeks, while the control group will not participate in any exercise program, but they will maintain the daily physical activity. Both groups will be evaluated at two time points: initial assessment (M1) at the start of training and final assessment (M2) after 32 weeks

Multicomponent Training

Maintenance OTHER

Participants were instructed to maintain daily life activities regarding physical activity.

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being aged 60 years or older;
• maintaining functional independence in daily tasks;
• having no severe chronic diseases or medications to sleep that could affect the results:
• do not have significant cardiovascular, muscular, metabolic, or joint complications.

You may not qualify if:

• Less than 60 years old.
• Be dependent of caregiver in daily life activities.
• Use medication to sleep or tranquilizers.
• Have cardiovascular, muscular, metabolic or joint diseases.

Sponsors & Collaborators

• Instituto Politécnico de Bragança: lead
• Research Center for Active Living and Wellbeing: collaborator
• University of Alcala: collaborator

Study Sites (1)

Instituto Politécnico de Bragança

Bragança, Braganza District, 5300-253, Portugal

Location

Related Publications (2)

• Solis-Navarro L, Masot O, Torres-Castro R, Otto-Yanez M, Fernandez-Jane C, Sola-Madurell M, Coda A, Cyrus-Barker E, Sitja-Rabert M, Perez LM. Effects on Sleep Quality of Physical Exercise Programs in Older Adults: A Systematic Review and Meta-Analysis. Clocks Sleep. 2023 Mar 23;5(2):152-166. doi: 10.3390/clockssleep5020014.

  PMID: 37092426 BACKGROUND

• Rodrigues F, Jacinto M, Figueiredo N, Monteiro AM, Forte P. Effects of a 24-Week Low-Cost Multicomponent Exercise Program on Health-Related Functional Fitness in the Community-Dwelling Aged and Older Adults. Medicina (Kaunas). 2023 Feb 15;59(2):371. doi: 10.3390/medicina59020371.

  PMID: 36837572 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Maintenance

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Pedro Miguel Forte, PhD

  University of Alcala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 17, 2024
• Study Start: September 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: September 15, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)