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Immediate and Long-term effectiveness of a Therapeutic Exercise Protocol in patients with Dementia

Immediate and Long-term effectiveness of a Therapeutic Exercise Protocol in patients with Dementia

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001475538
Enrollment
10
Registered
2024-12-18
Start date
2025-01-07
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Therapeutic exercise (TE) has been shown to be an effective tool for slowing physical and cognitive decline in patients with dementia; however, the true effectiveness on physical and functional variables and the degree of permanence of the effects of TE when therapy is discontinued are still unknown. For all these reasons, protocolized and minitorized therapeutic exercise could reduce fatigue, improve general functionality, trunk control, balance, gait and independence in activities of daily living in patients with dementia.

Interventions

Subjects will be recruited from collaborating centers and will be informed of the development of this study, carrying out the process of information and informed consent with the subject or with the family member or guardian. In a first interview, compliance with the eligibility criteria will be determined, for which the MMSE questionnaire will be administered and questions related to the health status that imply a possible exclusion from the study due to non-compliance with said criteria will b

Subjects will be recruited from collaborating centers and will be informed of the development of this study, carrying out the process of information and informed consent with the subject or with the family member or guardian. In a first interview, compliance with the eligibility criteria will be determined, for which the MMSE questionnaire will be administered and questions related to the health status that imply a possible exclusion from the study due to non-compliance with said criteria will be asked. Once compliance with the eligibility criteria has been confirmed and the desire to participate in the study has been corroborated, a first complete assessment will be carried out to determine the initial status of each subject. Due to the impossibility of blinding the physiotherapist and the subject, and to minimize the risk of bias, the person responsible for carrying out the initial and final assessments will be completely unaware of the objective and protocol carried out in this study. Once the initial assessment is completed, the intervention process will begin with therapeutic exercise for 12 weeks, in groups of 3 persons, with the following characteristics: - 45 minutes a day - Moderate intensity in aerobic and strength exercises or 60-75% Maximum heart rate or Borg scale: 5-6 o 8-12 repetitions in strength exercises (30-50% 1RM) - 3 days a week, on non-consecutive days: o Day 1: Aerobic exercise + Strength exercise + Balance and flexibility exercises. o Day 2: Aerobic exercise + Strength exercise + Balance and flexibility exercise o Day 3: Aerobic exercise + Balance exercise + Task-oriented training The exercise protocol recommended by the American College of Sports Medicine and current evidence maintains that the intervention should include aerobic exercise, muscle strengthening, balance and flexibility exercises. This protocol will also be accompanied by cognitive components, with the aim of improving executive functions, memory, attention and language. Therefore, during the performance of motor tasks, tasks related to language (listing colors, fruits, animals) and numerical tasks (counting backwards, simple addition or subtraction calculations, etc.) will be included. The cognitive exercises will be performed during the specific physical exercises, working on double tasks. Aerobic exercise will be performed using a bicycle or treadmill. Strengthening exercise will be performed using dumbbells, weights or elastic bands. They will be performed through large muscle groups, including 6-8 exercises, of 8-10 repetitions, with 2-3 sets each. A familiarization phase will be carried out with each exercise, and then the intensity will be adjusted according to the assigned group. Flexibility and balance exercises may include stretching, yoga or Pilates exercises, tandem or semi-tandem tasks, multi-directional movements and body weight transfers. During the development of the session, the physiotherapist will monitor the heart rate to ensure that it is within the established range for moderate intensities. Likewise, the subject will be asked during the development of the exercises, what is the degree of perceived effort using the Borg scale, which must always remain within the corresponding range. At the end of each session, the physiotherapist will record the degree of fatigue and satisfaction with the therapy corresponding to the exercise performed. After 12 weeks of intervention, the complete evaluation will be carried out again, collecting functional, cognitive, depression and functional independence data by an external examiner. Likewise, the physiotherapist satisfaction questionnaire will be administered to determine the degree of acceptance of the applied protocol, and to find out the details or difficulties that may have arisen during its application. The data will be collected in a data notebook with an Excel database. Where adherence to the intervention, attendance at sessions, exercise diary, heart rate, degree of fatigue, etc.

Sponsors

Elena Sánchez Jiménez/ Catholic University of Avila
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

• Mild-moderate cognitive impairment (scores between 10 and 23 on the Mini-Mental State Examination (MMSE) scale).

Exclusion criteria

• Comorbidities with other musculoskeletal or cardiovascular disorders that pose a limitation or contraindication to performing the therapeutic exercise protocol. • Suffering from sequelae derived from SARS-CoV2 infection, or persistent COVID. • Inability to walk independently.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026